Trial intelligence / Profile preview

PDS01ADC with Docetaxel in mCSPC and mCRPC

NCT04633252Phase 2

Key facts

Status: Recruiting
Start: Feb 2021
Primary completion: Dec 2026
Countries: 1
Sponsor: National Cancer Institute
Modality: Immunomodulatory ADCs, Cytokines & Interferons, Engineered Antibody Formats

Drugs: NHS-IL-12
Conditions: prostate cancer (PCa)metastatic castration-resistant prostate cancer (mCRPC)

Overview

Phase 2, open-label trial of NHS-IL-12 in prostate cancer (PCa) and metastatic castration-resistant prostate cancer (mCRPC) (4 arms), sponsored by National Cancer Institute. Primary endpoints: Clinical Efficacy (PSA <0.2 ng/ml or median PFS) and Safety and Tolerability (DLTs) at 6 weeks. Started Feb 2021; status: recruiting.

Design

4 arms

Study design: Non-randomizedOpen-label

1/Dose Escalation
Docetaxel plus PDS01ADC dose escalation with optional prednisone and ADT
2/Safety Run-in
Docetaxel plus PDS01ADC RP2D plus M7824 with optional prednisone and ADT
3/mCSPC: Dose Expansion
Docetaxel plus PDS01ADC RP2D with optional prednisone, ADT, and abiraterone
4/mCRPC: Dose Expansion
Docetaxel plus PDS01ADC RP2D with optional prednisone and ADT

Who it enrols

Men >=18 years with metastatic castration-sensitive or castration-resistant prostate cancer, adequate organ function, and ECOG PS 0-2. Excludes patients with uncontrolled hypertension, active autoimmune disease, or prior docetaxel for mCRPC.

Endpoints

Primary

Clinical Efficacy (PSA <0.2 ng/ml or median PFS)4-8 weeks
Safety and Tolerability (DLTs)6 weeks

Secondary

Radiographic Response Rates4-8 weeks
Percentage of patients with a 50% PSA decline from baseline4-8 weeks
Radiographic and biochemical time to progression7 months

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