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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07165067




Registration number
NCT07165067
Ethics application status
Date submitted
20/08/2025
Date registered
10/09/2025
Date last updated
10/09/2025

Titles & IDs
Public title
A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1, Open-label Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients With Solid Tumors.
Secondary ID [1] 0 0
AP601-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumours 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AP601

Experimental: Cohort 1 - Cohort 1: 0.5 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days)

Experimental: Cohort 2 - Cohort 2: 1.25 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days)

Experimental: Cohort 3 - Cohort 3: 2.5 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days)

Experimental: Cohort 4 - Cohort 4: 5.0 mg/kg Participants will receive a single infusion of AP601 once every 2 weeks (14 days)

Experimental: Cohort 5 - Cohort 5: 7.5 mg/kg

Experimental: Cohort 6 - Cohort 6: 10.0 mg/kg


Treatment: Drugs: AP601
AP601 is a fully human bispecific antibody designed for the treatment of CD73-expressing solid tumours. Participants will receive a single infusion of AP601 once every 2 weeks (14 days) (Q2W) for up to 12 months. All doses of AP601 will be admistered intraveneously. The infusion time for all doses of AP601 in each patient will be approximately 60 to 120 minutes.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the tolerability (MTD and/or maximum administered dose [MAD] of AP601 in patients with solid tumours.
Timepoint [1] 0 0
Initial 28 days from the first dose of AP601 which is Cycle1Day1 (each cycle is 14 days) until Cycle2Day14 (each cycle is 14 days)
Primary outcome [2] 0 0
To determine the tolerability of Recommend Phase 2 Dose [RP2D])- MTD and/or maximum administered dose [MAD] of AP601 in patients with solid tumours.
Timepoint [2] 0 0
TEAEs and SAEs will be assessed at Screening until 90-day safety follow up visit.
Primary outcome [3] 0 0
To determine the tolerability of Recommend Phase 2 Dose [RP2D])
Timepoint [3] 0 0
Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose (each cycle is 14 days), 0-6 hours, End of Trial Visit.
Primary outcome [4] 0 0
To determine the tolerability of Recommend Phase 2 Dose [RP2D])
Timepoint [4] 0 0
PD will be assessed Cycle 1 - pre-dose, 24 hous, 72 hours, 168 hours. Cycle 2- pre-dose, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Pre-dose (each cycle is 14days) and at End of Trial Visit.
Primary outcome [5] 0 0
To determine the tolerability of Recommend Phase 2 Dose [RP2D]
Timepoint [5] 0 0
Antitumour activity data will collected at End of Trial Visit , Safety Follow Up Visit (End of Trial + 30 days), Safety FUP Visit (End of Trial + 90 days) and at Survival Follow Up.
Primary outcome [6] 0 0
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (haematology)
Timepoint [6] 0 0
Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle 3 Day1 to Cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit (EOT) and Safety Follow Up (EOT+ 30 days)
Primary outcome [7] 0 0
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (clinical chemistry)
Timepoint [7] 0 0
Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 until Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
Primary outcome [8] 0 0
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (Coagulation)
Timepoint [8] 0 0
Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 to last Cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
Primary outcome [9] 0 0
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (Thyroid Function tests )
Timepoint [9] 0 0
Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 - until last Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (EOT+ 30 days)
Primary outcome [10] 0 0
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis)
Timepoint [10] 0 0
Assessed at Screening, Cycle1 Day1 , Cycle2 Day1, Cycle3 Day1 - until last Cycle 24 Day 1 (each cycle is of 14 days), End of Trial Visit and Safety FUP (End of Trial Visit+ 30 days)
Primary outcome [11] 0 0
To determine the tolerability of RP2D - Number of Participants with a Change from baseline in Vital signs measurements Pulse rate [PR], systolic and diastolic blood pressure [BP], temperature and respiratory rate [RR]
Timepoint [11] 0 0
Assessed at Screening, Cycles 1 and 2 - Day 1, Day 2, Day 4, Day 8 Cycle 3 Day 1 - until last cycle 24 Day 1 (each cycle is 14 days), End of Trial Visit (EOT), Safety FUP (EOT + 30 days).
Primary outcome [12] 0 0
To determine the tolerability of RP2D- Number of Participants with a Change from baseline in body weight
Timepoint [12] 0 0
Assessed at Screening, Cycles 1 and 2 - Day 1, Day 2, Day 4, Day 8 Cycle 3 Day 1 - until last cycle 24 Day 1(each cycle is 14 days), End of Trial Visit(EOT), Safety FUP (EOT + 30 days).
Primary outcome [13] 0 0
To determine the tolerability of RP2D- Change from baseline in Eastern Cooperative Oncology Group (ECOG) score
Timepoint [13] 0 0
Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 up until last cycle 24 Day1 (each cycle is of 14 days), End of Trial Visit(EOT)and Safety FUP (EOT + 30 days) Visit.
Primary outcome [14] 0 0
To determine the tolerability of RP2D- Change from baseline in measurements of HR in beats per minute
Timepoint [14] 0 0
Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial Visit(EOT) and Safety FUP (EOT + 30 days).
Primary outcome [15] 0 0
To determine the tolerability of RP2D- Change from baseline in measurements of PR interval via 12-lead electrocardiogram
Timepoint [15] 0 0
Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT ) Visit and Safety FUP (EOT + 30 days).
Primary outcome [16] 0 0
To determine the tolerability of RP2D- Change from baseline in measurements of QT interval via 12-lead electrocardiogram
Timepoint [16] 0 0
Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT) Visit and Safety FUP (EOT + 30 days).
Primary outcome [17] 0 0
To determine the tolerability of RP2D- Change from baseline in measurements of QRS duration via 12-lead electrocardiogram
Timepoint [17] 0 0
Assessed at Screening, Cycle1 Day1, Cycle2 Day1, Cycle3 Day1 until last cycle 24 Day 1(each cycle is of 14 days), End of Trial (EOT) Visit and Safety FUP (EOT + 30 days).
Secondary outcome [1] 0 0
To assess the PK of AP601 in patients with solid tumours - Serum PK concentration of AP601.
Timepoint [1] 0 0
Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24 - Predose (each cycle is 14 days), 0-6 hours and End of Trial Visit.
Secondary outcome [2] 0 0
To assess the PK of AP601 in patients with solid tumours - Individual maximum concentration values, directly determined from the serum concentration time profiles for each participant (Cmax)
Timepoint [2] 0 0
Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cyle 24- Predose(each cycle is 14 days), 0-6 hours and End of Trial Visit.
Secondary outcome [3] 0 0
To assess the PK of AP601 in patients with solid tumours -Serum clearance following IV administration (CL)
Timepoint [3] 0 0
Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 -to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
Secondary outcome [4] 0 0
To assess the PK of AP601 in patients with solid tumours -Area under the serum concentration-time curve (AUC) from time zero to 168 hours post-dose (AUC0-168)
Timepoint [4] 0 0
Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24 Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
Secondary outcome [5] 0 0
To assess the PK of AP601 in patients with solid tumours - AUC from time zero to the last time point with measurable concentration using the linear trapezoidal rule (AUClast)
Timepoint [5] 0 0
Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
Secondary outcome [6] 0 0
To assess the PK of AP601 in patients with solid tumours - The time to attain maximum concentration (Tmax)
Timepoint [6] 0 0
Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose (each cycle is 14days), 0-6 hours and End of Trial Visit.
Secondary outcome [7] 0 0
To assess the PK of AP601 in patients with solid tumours - Terminal elimination half-life (T1/2)
Timepoint [7] 0 0
Cycle 1 - Pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
Secondary outcome [8] 0 0
To assess the PK of AP601 in patients with solid tumours - Volume of distribution (Vz)
Timepoint [8] 0 0
Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hours, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
Secondary outcome [9] 0 0
To assess the PK of AP601 in patients with solid tumours - Trough concentration (Ctrough)
Timepoint [9] 0 0
Cycle 1 - pre-dose, immediately following End of Infusion (EOI), 4 hours, 24 hours, 72 hrs, 168 hours. Cycle 2- pre-dose, EOI, 4 hours, 24hours, 72hours, 168hours, Cycle 3 to Cycle 24- Predose(each cycle is 14days), 0-6 hours and End of Trial Visit.
Secondary outcome [10] 0 0
To assess the Immunogenicity of AP601 in patients with solid tumours.
Timepoint [10] 0 0
Assessed at Cycle1 Day1 - Pre-dose, Cycle2 Day1 - Predose, Cycle3 Day1- Predose until Last Cycle 24 Day 1 (each cycle is of 14 days) and End of Trial Visit.
Secondary outcome [11] 0 0
To assess the antitumor activity of AP601 in patients with solid tumours.
Timepoint [11] 0 0
Antitumour activity data will collected at End of Trial(EOT) Visit , Safety FUP Visit (EOT + 30 days), Safety Follow Up Visit (EOT + 90 days) and at Survival Follow Up.
Secondary outcome [12] 0 0
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Objective Response Rate (ORR)
Timepoint [12] 0 0
Upto 2 years
Secondary outcome [13] 0 0
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Disease Control Rate (DCR)
Timepoint [13] 0 0
Upto 2 years
Secondary outcome [14] 0 0
To evaluate the preliminary efficacy of AP601 in patients with solid tumours- Clinical Benefit Response (CBR)
Timepoint [14] 0 0
Upto 2 years

Eligibility
Key inclusion criteria
1. Patients with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors. Patients must be relapsed or refractory to at least one standard-of-care therapy, and/or have refused standard-of-care therapy.

2. Eastern Cooperative Oncology Group performance status of 0 to 1 at Screening, with an estimated life expectancy of at least 3 months.

3. Disease must have at least 1 assessable (long diameter =1 cm) lesion for evaluation of response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

4. Patients with adequate organ and bone marrow function, in the absence of growth factors, including the specific laboratory findings of Absolute neutophil count, platelet count, Haemoglobin, AST, ALT, Serum total Bilirubin, Alkaline phosphatase, prothrombin time, INR or activated partial thromboplastin time, creatinine and albumin.

5. Female Volunteers must be of nonchild bearing potential i.e, surgically sterilised at least 6 weeks before Screening Visit or postmenopausal.

6. Females of childbearing potential must have a negative pregnancy test, agree not to attempt to become pregnant or donate Ova and agree to use contraception from one month prior to Screening until at least 90 days after last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.

Male Vonuteers:

* Must agree not to donate sperm from signing the ICF until at aleast 90 days after the last dose of the study drug.
* If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception.
* Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has received concurrent antitumor treatment or IPs within 28 days of C1D1. The antitumor treatments include chemotherapy, radiotherapy, immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy.
2. Has received prior CD73-targeted and/or CD137-targeted therapeutics.
3. Has had major surgery within 28 days prior to C1D1 (excluding prior diagnostic biopsy).
4. Any unresolved toxicity (except alopecia) from prior therapy of =CTCAE Grade 1, prior to the day of the first dose of IP. Participants with Grade 2 toxicity that is not CS (e.g., alopecia, vitiligo), or that is deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
5. History of any other malignancy, which has been active or treated within the past 2 years, with the exception of thyroid cancer, cervical intraepithelial neoplasia, basal cell carcinoma and squamous cell carcinoma.
6. Prior history of an irAE with immunotherapy-related toxicities that resulted in discontinuation of prior immunotherapy.
7. Current symptomatic leptomeningeal disease or uncontrolled, untreated brain metastasis.
8. Has received any organ transplantation including allogeneic stem cell transplantation.
9. Has received blood transfusions or growth factor support = 14 days prior to screening.
10. Has any significant acute or chronic infections including:

1. Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of AP601.
2. Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
11. Current active, or history of, any autoimmune disease that may relapse or immunodeficiencies.
12. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before first dose of AP601.
13. Known severe hypersensitivity reactions to monoclonal antibodies.
14. Breastfeeding (or planning to breastfeed) at any time during the study, and for 90 days following study completion.
15. Participants with a current or recent (within the past 12 months) diagnosis of alcohol or non-prescribed drug abuse, as defined by local guidelines.
16. Evidence of cardiac dysfunction (defined as myocardial infarction within the last 6 months, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias, or known left ventricular ejection fraction [LVEF] <55%) or other CS cardiac pathology likely to impair the participants ability to participate in the study.
17. Uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, uncontrolled endocrinopathy, severe active peptic ulcer disease or gastritis.
18. Has received a live (or live attenuated) vaccination within 28 days of the first dose of AP601 and during the study period.
19. Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

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

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
20/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2028
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Pindara Private Hospital - Brisbane
Recruitment hospital [2] 0 0
Epworth HealthCare - Melbourne
Recruitment postcode(s) [1] 0 0
4217 - Brisbane
Recruitment postcode(s) [2] 0 0
3121 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AP Biosciences Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avance Clinical Pty Ltd.
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
Grace Lu
Address 0 0
Country 0 0
Phone 0 0
886-2-2653-2886
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our IPD sharing plan is not yet developed. We will consider data sharing at a later date.


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/NCT07165067