Castration Resistant Prostatic Cancer, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer
Conditions
Keywords
Prostate Cancer, Castration-resistant prostate cancer
Brief summary
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).
Interventions
BIOLOGICALJANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
DRUGDarolutamide
Darolutamide is dosed via oral tablets
Sponsors
Janux Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | 3 years |
| Incidence of Dose Limiting Toxicities (DLT) | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 3 years | Time from treatment initiation until death from any cause |
| Duration of Response | Up to 3 years | Time from documentation of complete response or partial response to disease progression using RECIST v1.1 and PCWG3 |
| Prostate Specific Antigen (PSA) response | Up to 3 years | Best reduction in PSA level achieved confirmed by a second PSA test ≥21 days later |
| Area under the concentration time curve to infinity of JANX007 (AUC0-inf) | Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years) | — |
| Maximum observed concentration of JANX007 (Cmax) | Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years) | — |
| Radiographic Progression Free Survival (rPFS) | Up to 3 years | Time from treatment initiation to radiographic evidence of disease progression using RECIST v1.1 and PCWG3 |
| Number of participants who develop anti-drug antibodies against JANX007 | Up to 3 years | — |
| Overall Response Rate | Up to 3 years | Proportion of participants who achieve a complete response or partial response using RECIST v1.1 and PCWG3 |
Countries
Australia, United States
Contacts
CONTACTJanux Therapeutics
STUDY_DIRECTORJanux Therapeutics, MD
Janux Therapeutics
Outcome results
None listed