Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000947303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
12/07/2026
Date registered
Help: Date registered
30/07/2026
Date last updated
Help: Date last updated
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Study to evaluate the safety, effects, and early effectiveness of IDB-1829 in combination with Enzalutamide in patients with advanced prostate cancer
Scientific title
A Phase 2a Open-Label, Multicenter, First-in-Human Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDB-1829 in Combination with Enzalutamide in Participants with Metastatic Castration-Resistant Prostate Cancer(mCRPC)
Additional trial identifiers [1] 317859 0
IDB-1829-1001
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Metastatic Castration-Resistant Prostate Cancer 342797 0
Condition category
Condition code
Cancer 338921 338921 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
- Participants will receive IDB-1829 orally once daily in combination with enzalutamide 160 mg orally once daily, administered in continuous 21-day treatment cycles. IDB-1829 will be evaluated using a dose-escalation design, with doses ranging from 1 mg to 7 mg once daily, depending on the participant cohort and dose level assigned.
-Treatment will continue until unacceptable toxicity, disease progression, or study discontinuation criteria (Investigator judgment that continued treatment is not in the participant's best interest, Pregnancy (of a Women of Childbearing Potential (WOCBP) partner), Sponsor decision to terminate the study) are met.
- up to 6 participants will be enrolled in this part.
- Study Duration (per participant): Screening up to 28 days; treatment until disease progression, unacceptable toxicity, or other discontinuation criterion; 30-day safety follow-up (SFU); long-term follow-up every 3 months until 2 years after the last participant ends treatment or end of study (EOS).
Intervention code [1] 334699 0
Treatment: Drugs
Description of the comparator or control
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346138 0
Incidence of combination DLTs, AEs, SAEs, and changes from baseline in laboratory parameters, ECGs, vital signs, and physical examinations. (composite primary outcome)
Timepoint [1] 346138 0
From Screening (-28 days to 0 days) through Safety follow up visit (Day 30) which applies for all the above assessments.
Secondary outcome [1] 464746 0
Pharmacokinetics (PK) profile of IDB-1829
Timepoint [1] 464746 0
2 hours (Pre-dose) and multiple post-dose samples at 0.5, 1, 2, 4, and 8 hours on Cycle 1 Day 1 and Cycle 1Day 15
Secondary outcome [2] 464747 0
Preliminary Antitumor Activity (Composite Secondary Outcome)
Timepoint [2] 464747 0
Baseline (Screening: Day -28 to Day 1); Cycle 1 Day 1, Day 8 (±2 days), Day 15 (±2 days); Cycle 2 Day 1, Day 8(±2 days), Day 15 (±2 days); Day 1 of subsequent cycles (±2 days); Weeks 12, 18, and 24 (for Disease Control Rate and Prostate-Specific Antigen response); and up to End of Treatment (EOT).

Eligibility
Key inclusion criteria
1. Age 18 or older
2. Confirmed diagnosis of prostate cancer (adenocarcinoma) that has spread to other parts of the body(metastatic disease)
3. Cancer has stopped responding to hormone therapy (castration-resistant prostate cancer, or mCRPC)
4. Currently on hormone therapy (androgen deprivation therapy) or has had surgical removal of thetesticles, with testosterone levels at or below 50 ng/dL
5. Cancer has gotten worse on or after the most recent treatment
6. Able to carry out normal daily activities with little or no physical limitation (ECOG performance status 0 or1)
7. Has not received any prior treatment for mCRPC
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Healthy volunteers
No
Key exclusion criteria
1. Received chemotherapy, immunotherapy, targeted therapy, or another investigational cancer treatmentwithin 21 days before starting study treatment (or within 6 weeks for prior radiopharmaceutical therapysuch as lutetium-177 PSMA)
2. Received radiation therapy within 28 days before starting study treatment
3. Prostate cancer with small cell or neuroendocrine features on any prior or current biopsy
4. Stroke or mini-stroke (TIA) within the past 6 months
5. History of organ transplant

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2027
Actual
Date of last participant enrolment
Anticipated
30/07/2027
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 322398 0
Commercial sector/Industry
Name [1] 322398 0
Interdict Bio
Country [1] 322398 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Interdict Bio
Address
Country
United States of America
Secondary sponsor category [1] 325323 0
None
Name [1] 325323 0
Address [1] 325323 0
Country [1] 325323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320897 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 320897 0
Ethics committee country [1] 320897 0
Australia
Date submitted for ethics approval [1] 320897 0
27/05/2026
Approval date [1] 320897 0
26/06/2026
Ethics approval number [1] 320897 0

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

Contacts
Principal investigator
Name 152002 0
Dr Craig Gedye
Address 152002 0
Icon Cancer Centre, 520 South Road Tennyson Centre Kurralta Park Adelaide South Australia 5037
Country 152002 0
Australia
Phone 152002 0
+61 08 84740220
Fax 152002 0
Email 152002 0
[email protected]
Contact person for public queries
Name 152003 0
Cassandra Choe-Juliak
Address 152003 0
Interdict Bio P.O. Box 460369 San Francisco, CA 94114
Country 152003 0
United States of America
Phone 152003 0
+1 347 433 7515
Fax 152003 0
Email 152003 0
[email protected]
Contact person for scientific queries
Name 152004 0
Cassandra Choe-Juliak
Address 152004 0
Interdict Bio P.O. Box 460369 San Francisco, CA 94114
Country 152004 0
United States of America
Phone 152004 0
+1 347 433 7515
Fax 152004 0
Email 152004 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided
Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.