78278343PBPCR1004
Prostate cancer
A Phase 1b study of pasritamig (KLK2 × CD3 bispecific antibody) in combination with JNJ-95298177 (PSMA-targeting ADC) in participants with mCRPC
Phase
b
Compound
Pasritamig (KLK2 × CD3 bispecific Ab) + JNJ-95298177 (PSMA-targeting ADC)
NCT identifier
NCT07082920
Enrollment
N=~140
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contact details, please visit
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contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- mCRPC with histologic confirmation of adenocarcinoma
- Measurable or evaluable disease
- PSA ≥2 ng/mL at screening
- Prior orchiectomy or medical castration; or receiving ongoing ADT with a GnRHa
- ECOG PS 0 or 1
- No symptomatic leptomeningeal disease or brain metastases
- No treatment with any anticancer or investigational agents within 14 days prior to the first study dose
- No prior KLK2-targeted therapy
- No prior PSMA-targeting therapy
- No prior ADCs with microtubule inhibitor payloads
- No T-cell redirecting treatment (eg, CD3-directed bispecific or CAR T-cell therapy) within 90 days prior to first study dose
Study
design
Primary outcomes:
- DLTs
- AEs by severity
Secondary outcomes:
- Objective response rate
- rPFS
- TTR
- PSA response rate
- DOR
- Serum concentration of pasritamig and JNJ-95298177
- ADAs
*Not a complete list of inclusion and exclusion criteria. †Dose de-escalation in accordance with BOIN.
ADA, antidrug antibody; ADC, antibody-drug conjugate; ADT, androgen deprivation therapy; AE, adverse event; BOIN, Bayesian optimal interval; CAR, chimeric antigen receptor; CD, cluster of differentiation; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GnRHa, gonadotropin-releasing hormone analog; KLK2, human kallikrein-2; mCRPC, metastatic castration-resistant prostate cancer; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; rPFS, radiographic progression-free survival; TTR, time to response.