A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
Recruiting
Phase 1
Phase 2
Interventional Study
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Clear Cell Renal Cell Carcinoma (ccRCC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 345 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
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About This Trial
The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.
The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of …
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
mCRPC cohorts (men):
1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.
3. Has received…
Contacts