A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Conditions

• Metastatic Castration-Resistant Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FG-3246 — DRUG
  FG-3246 will be administered per schedule specified in the arm description.

Study Details

The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.

Key Dates

Start date

Feb 22, 2026

Status verified

May 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

75 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: FG-3246 1.8 mg/kg
  Participants will receive FG-3246 1.8 milligrams (mg)/kilogram (kg) administered via intravenous (IV) infusion on Day 1 of each 21-day treatment cycle (every 3 weeks \[Q3W\]) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study.
• Experimental: FG-3246 2.4 mg/kg
  Participants will receive FG-3246 2.4 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study.
• Experimental: FG-3246 2.7 mg/kg
  Participants will receive FG-3246 2.7 mg/kg administered via IV infusion on Day 1 of each 21-day treatment cycle (Q3W) until radiographic progression, unacceptable safety and tolerability, participant or investigator decision to stop treatment, other withdrawal criteria are met, or sponsor decision to close the study.

Primary Outcome Measure

Radiographic Progression-free Survival (rPFS) By Investigator Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria [ Time Frame: Until radiographic progression is noted (up to approximately 25 months) ]

Central Contacts

• Javier Moreno
  415-978-1466
  [email protected]
• Mairead Carney
  415-978-1337
  [email protected]

Locations (20)

Find similar trials in Goodyear, AZ

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