Clinical trial · Interventional
Phase 1 Trial to Study JANX013 and JANX007 Combination in mCRPC
A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant Prostate Cancer
NCT07813637CI-TRIAL-00126215PSMA-013-001recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-Resistant Prostate Cancer (CRPC) | Castration-Resistant Prostate Carcinoma | ALIAS | 0.85 |
| Metastatic Castration-Resistant Prostate Cancer Patients | Prostate Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JANX007 | Drug | — | UNRESOLVED |
| JANX013 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Participants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort
- interventionNames
- Drug: JANX013
- Drug: JANX007
- type
- EXPERIMENTAL
- label
- Dose Expansion
- description
- Participants receive JANX013 in combination with JANX007. Participants will be dosed at levels previously declared tolerable.
- interventionNames
- Drug: JANX013
- Drug: JANX007
Primary outcomes (2)
- measure
- Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.