Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Purpose
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Conditions
- Prostate Cancer
- Metastatic Castration-resistant Prostate Cancer
- Castration Resistant Prostatic Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male ≥18 years of age at the time of signing informed consent - Histologically or cytologically confirmed adenocarcinoma of the prostate - For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible - Adequate organ function - For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible. - For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings - For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor - For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
Exclusion Criteria
- Prior solid organ transplant - Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy - Clinically significant cardiovascular disease - For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting - For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC - For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting - For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC - Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other) - Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation |
IV dosing during 21- or 28-day cycles. Dosage per cohort will increase to determine the maximum tolerable dose. |
|
|
Experimental Backfill Expansion |
IV dosing during 21- or 28-day cycles. Subjects will be dosed at levels previously declared tolerable. |
|
|
Experimental Monotherapy Expansion Parts A - D |
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose (RP2D). |
|
|
Experimental Combination Expansion |
IV dosing during 21- or 28-day cycles. Subjects will be dosed at preliminary recommended phase 2 dose |
|
Recruiting Locations
University of Alabama at Birmingham Hospital
Birmingham, Alabama 35249
Birmingham, Alabama 35249
More Details
- Status
- Recruiting
- Sponsor
- Janux Therapeutics