Recruiting NCT07545811
Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JANX014.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration-resistant Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer
Overview
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
- Biological JANX014
JANX014 will be administered via IV dosing
Primary outcome measures
- Incidence of Dose Limiting Toxicities (DLTs) [Time frame: 2 years]
- Incidence of adverse events (AE) and Serious Adverse Events (SAE) [Time frame: 2 years]
Secondary outcome measures (7)
- Area under the curve from time 0 to t of JANX014 (AUC0-t) [Time frame: up to 2 years]
- Maximum observed concentration of JANX014 (Cmax) [Time frame: up to 2 years]
- Number of participants who develop anti-drug antibodies against JANX014 [Time frame: up to 2 years]
- Prostate Specific Antigen (PSA) response [Time frame: up to 2 years]
- Overall Response Rate [Time frame: up to 2 years]
- Duration of Response [Time frame: up to 2 years]
- Radiographic Progression Free Survival (rPFS) [Time frame: up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Research Site — Nashville
Identifiers
NCT: NCT07545811 · PRCA-014-001