Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer
Conditions
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 JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Interventions
BIOLOGICALJANX014
JANX014 will be administered via IV dosing
Sponsors
Janux Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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: 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 Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC 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 any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy * Clinically significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) | 2 years |
| Incidence of adverse events (AE) and Serious Adverse Events (SAE) | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve from time 0 to t of JANX014 (AUC0-t) | up to 2 years |
| Maximum observed concentration of JANX014 (Cmax) | up to 2 years |
| Number of participants who develop anti-drug antibodies against JANX014 | up to 2 years |
| Prostate Specific Antigen (PSA) response | up to 2 years |
| Overall Response Rate | up to 2 years |
| Duration of Response | up to 2 years |
| Radiographic Progression Free Survival (rPFS) | up to 2 years |
Countries
United States
Contacts
CONTACTJanux Therapeutics, MD
Outcome results
None listed