Castration-Resistant Prostate Cancer (CRPC), Metastatic Castration-Resistant Prostate Cancer Patients, Metastatic Prostate Cancer, Prostate Cancer
Conditions
Keywords
mCRPC, Metastatic Castration-Resistant Prostate Cancer, PSMA, Prostate-Specific Membrane Antigen, CD3 T cell engager, T cell engager, Bispecific antibody, Immunotherapy, Prostate cancer metastatic
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 JANX013 in combination with JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Interventions
DRUGJANX013
JANX013 will be administered via IV dosing.
DRUGJANX007
JANX007 will be administered via IV dosing.
Sponsors
Janux Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are assigned to sequential cohorts in a dose-escalation phase followed by dose-expansion cohorts evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JANX013 in combination with JANX007 in participants with metastatic castration-resistant prostate cancer.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male participants ≥ 18 years of age at the time of signing informed consent * Histologically or cytologically confirmed adenocarcinoma of the prostate For Dose Escalation: \- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) in any setting and have received at least 1 taxane regimen (in any setting), or who are medically unsuitable or have actively refused treatment with a taxane regimen. For Dose Expansion: * Must be in the first-line or second-line setting for mCRPC or metastatic androgen pathway modulation resistant disease and must have received 1 novel ARPI in any setting. * Adequate organ function Key
Exclusion criteria
* Prior treatment with any chimeric antigen receptor (CAR) T-cell therapy, any approved or investigational TCE, or any T-cell costimulatory agent * Clinically significant cardiovascular disease * Prior solid organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) | 2 years | — |
| Incidence of cytokine release syndrome (CRS) | 2 years | Cytokine release syndrome (CRS) assessed according to ASTCT criteria. |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve from 0 to t of JANX013 and JANX007 | Up to 2 years |
| Maximum observed concentration of JANX013 and JANX007 | Up to 2 years |
| Time to maximum concentration of JANX013 and JANX007 | Up to 2 years |
| Number of participants who develop anti-drug antibodies (ADAs) against JANX013 and JANX007 | Up to 2 years |
| Prostate-specific antigen (PSA) response | Up to 2 years |
| Radiographic progression-free survival (rPFS) | Up to 2 years |
| Duration of response (DOR) | Up to 2 years |
| Disease control rate (DCR) | Up to 2 years |
Countries
United States
Contacts
CONTACTJanux Therapeutics, MD
Outcome results
None listed