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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06789172




Registration number
NCT06789172
Ethics application status
Date submitted
13/01/2025
Date registered
23/01/2025

Titles & IDs
Public title
A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors
Scientific title
A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
OKN-4395-121
Universal Trial Number (UTN)
Trial acronym
INVOKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumours 0 0
Sarcoma 0 0
HNSCC 0 0
Non Small Cell Lung Cancer 0 0
Head and Neck Squamous Cell Carcinoma 0 0
NSCLC 0 0
Pancreatic Adenocarcinoma 0 0
Colorectal Cancer (CRC) 0 0
Myxofibrosarcoma (MFS) 0 0
Solitary Fibrous Tumors 0 0
Dedifferentiated Liposarcoma 0 0
Undifferentiated Pleomorphic Sarcoma (UPS) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OKN4395
Other interventions - Pembrolizumab
Other interventions - Fasting
Other interventions - Fed
Treatment: Drugs - H2 Receptor Antagonist

Experimental: Monotherapy Dose Escalation Phase (Phase 1a) - The Monotherapy Escalation Phase will include increasing doses of OKN4395 alone in patients with solid tumors with a COX2-associated immunosuppressive pathway.

Experimental: Combination Dose Confirmation Phase (Phase 1a) - The Combination Dose Confirmation Phase will include increasing or decreasing doses of OKN4395 in combination with pembrolizumab in patients with solid tumors with a COX2-associated immunosuppressive pathway. The first dose level used will be 1 level below the identified OBD/MTD for monotherapy. Subsequent dose levels tested will either be increased or decreased in response to observed toxicity.

Experimental: Phase 1b Cohort 1: Sarcoma Food Effect (Fasted) - Fasted first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.

Experimental: Phase 1b Cohort 1: Sarcoma Food Effect (Fed) - Fed first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.

Experimental: Phase 1b Cohort 2: Pancreas Gastric pH Effect (with H2RA) - Co-administered H2RA (H2 receptor antagonist; famotidine) first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.

Experimental: Phase 1b Cohort 2: Pancreas Gastric pH Effect (without H2RA) - No co-administered H2RA (H2 receptor antagonist; famotidine) first dose, and OBD/MTD (mono) dose of OKN4395 as monotherapy for the remainder of treatment.

Experimental: Phase 1b Cohort 3: NSCLC - OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab

Experimental: Phase 1b Cohort 4: Colorectal Cancer - OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab

Experimental: Phase 1b Cohort 5: HNSCC - OKN4395 (OBD/MTD combination dose) in combination with pembrolizumab


Treatment: Drugs: OKN4395
OKN4395 oral dosing twice per day

Other interventions: Pembrolizumab
200 mg IV every 3 weeks

Other interventions: Fasting
Fasting before first dose of OKN4395

Other interventions: Fed
Food provided to patient before first OKN4395 dose

Treatment: Drugs: H2 Receptor Antagonist
Famotidine 20 mg IV (as a slow push over 2 minutes) administered 3 hours prior to OKN4395
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of DLTs in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab. (Phase 1a)
Timepoint [1] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Primary outcome [2] 0 0
Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Timepoint [2] 0 0
From enrolment of the first participant to the end of Phase 1a; up to 27 months
Primary outcome [3] 0 0
Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Timepoint [3] 0 0
From enrolment of the first participant to the end of Phase 1a; up to 27 months
Primary outcome [4] 0 0
Incidence of dose interruptions, dose reductions, and dose intensities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Timepoint [4] 0 0
From enrolment of the first participant to the end of Phase 1a; up to 27 months
Primary outcome [5] 0 0
Incidence and severity of clinically relevant ECG abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Timepoint [5] 0 0
From enrolment of the first participant to the end of Phase 1a; up to 27 months
Primary outcome [6] 0 0
Incidence and severity of laboratory abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Timepoint [6] 0 0
From enrolment of the first participant to the end of Phase 1a; up to 27 months
Primary outcome [7] 0 0
Incidence and severity of clinically relevant changes in vital signs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1a)
Timepoint [7] 0 0
From enrolment of the first participant to the end of Phase 1a; up to 27 months
Primary outcome [8] 0 0
To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Timepoint [8] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [1] 0 0
To assess the overall response rate in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Timepoint [1] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [2] 0 0
To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Timepoint [2] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [3] 0 0
To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Timepoint [3] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [4] 0 0
To assess the progression-free survival in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Timepoint [4] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [5] 0 0
To assess the time to treatment failure in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Timepoint [5] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [6] 0 0
To assess the overall survival rate at 24 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1a)
Timepoint [6] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [7] 0 0
To characterize the maximum plasma concentration (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Timepoint [7] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [8] 0 0
To characterize the area under the curve (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Timepoint [8] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [9] 0 0
To characterize the terminal half life (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Timepoint [9] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [10] 0 0
To characterize the clearance (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Timepoint [10] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [11] 0 0
To characterize the accumulation index (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1a)
Timepoint [11] 0 0
From enrolment of the first participant until the end of Phase 1a or until the DLT threshold is reached; up to 27 months
Secondary outcome [12] 0 0
To assess the disease control rate at >=12 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Timepoint [12] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [13] 0 0
To assess the duration of response in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Timepoint [13] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [14] 0 0
To assess the progression-free survival in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Timepoint [14] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [15] 0 0
To assess the time to treatment failure in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Timepoint [15] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [16] 0 0
To assess the overall survival rate at 24 weeks in participants treated with OKN4395 as monotherapy and in combination with pembrolizumab in selected cancer types. (Phase 1b)
Timepoint [16] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [17] 0 0
Incidence and severity of TEAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Timepoint [17] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [18] 0 0
Incidence and severity of SAEs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Timepoint [18] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [19] 0 0
Incidence of dose interruptions, dose reductions, and dose intensities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Timepoint [19] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [20] 0 0
To characterize the maximum plasma concentration (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Timepoint [20] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [21] 0 0
Incidence and severity of clinically relevant ECG abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Timepoint [21] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [22] 0 0
Incidence and severity of laboratory abnormalities in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Timepoint [22] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [23] 0 0
Incidence and severity of clinically relevant changes in vital signs in participants treated with OKN4395 as a monotherapy and in combination with pembrolizumab in solid tumors. (Phase 1b)
Timepoint [23] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [24] 0 0
To characterize the area under the curve (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Timepoint [24] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [25] 0 0
To characterize the terminal half life (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Timepoint [25] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [26] 0 0
To characterize the clearance (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Timepoint [26] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b
Secondary outcome [27] 0 0
To characterize the accumulation index (pharmacokinetics) of OKN4395 and its AG metabolite. (Phase 1b)
Timepoint [27] 0 0
From enrolment of first participant in Phase 1b until 24 weeks after the last participant is enrolled in Phase 1b; up to 12 months from beginning of Phase 1b

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed disease, locally advanced or metastatic:

For Phase 1a:

Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.

For Phase 1b:

For all cohorts, in the opinion of the investigator, all appropriate authorised treatment options should be exhausted
* Cohort 1: Sarcoma (fibrous sarcoma [myxofibrosarcoma or solitary fibrous tumor], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.
* Cohort 2: Pancreatic adenocarcinoma, with no more than 3 prior lines of systemic therapy. When known, KRAS and BRCA status should be provided.
* Cohort 3: NSCLC (squamous or adenomatous without EGFR/ALK mutations), with previous platinum-based chemotherapy and a previous PD-(L)1 CPI regimen (unless not eligible/unwilling to receive such therapies), and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.
* Cohort 4: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.
* Cohort 5: HNSCC (oral cavity, oropharynx, larynx, hypopharynx), with a previous regimen containing a PD-(L)1 CPI (unless not eligible/unwilling to receive such therapies), and no more than 3 prior lines of systemic therapy. When known, PD-L1 and HPV status should be provided.
2. ECOG performance status of 0 or 1.
3. Recovery from any medically relevant AE/irAE from previous treatment regimen (defined as recovery to Grade =1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs [not worsened to Grade >2 for >3 months prior to screening]).
4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year [Phase 1a], or within 90 days and after the last administration of the previous systemic therapy [Phase 1b] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).
5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators/radiologists.
6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.
7. The willingness and ability to comply with the food effect (Phase 1b Cohort 1), or gastric pH effect (Phase 1b Cohort 2) evaluation randomizations and requirements.
8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):

1. Hematological variables: absolute neutrophil counts =1.5 × 109 /L, platelet counts =75 × 109 /L, and hemoglobin =8 g/dL
2. Renal variables: creatinine clearance = 60 mL/min1
3. Hepatic variables: total serum bilirubin =1.5 × ULN, AST and ALT =3 × ULN, and ALP =2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin =5× ULN and direct bilirubin =1.5 x ULN)
4. Serum albumin =30 g/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:

1. Chemotherapy, ADCs, or other antibodies < 21 days
2. Immunotherapy or cellular therapy < 28 days
3. Radiation therapy (palliative radiation for bone pain <48 hours; stereotactic or small field brain irradiation <7 days; all other radiation therapy <14 days)
4. TKI or any other anticancer therapy < 5 half-lives or < 7 days, whichever is longer
2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies [including low dose steroids]).
3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.
4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.
5. Known active HBV or HCV infection or positive test(s) as per CDC guidance (Centers for Disease Control and Prevention, 2023, 2024) or HIV infection with CD4 lymphocyte count <350 cells/µL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level < 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening. No testing is required unless medically indicated or mandated by local authorities.
6. Known history of bleeding disorders, INR =1.5 × ULN at screening (or INR and/or aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.
7. Known H. pylori infection without proof of eradication at least 2 months prior to screening.
8. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395.
9. Acute treatment with any systemic steroid therapy (>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.
10. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.
11. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid = 160 mg/day, or 325 mg = 3 times/week is permitted).
12. Systemic treatment with strong inhibitors/inducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.
13. QTcF interval of > 450 ms based on mean of the central triplicate readings.
14. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).
15. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).
16. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).
17. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
166
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [2] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Epkin
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Precision For Medicine
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Epkin
Address 0 0
Country 0 0
Phone 0 0
+31 617676896
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06789172