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A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Malignancies

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523547-35-00
Enrollment
16
Registered
2026-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor Malignancies

Brief summary

How often side effects occur, including serious ones, side effects that meet study rules for a dose-limiting toxicity, and side effects that make people stop study treatment or cause death.

Detailed description

Overall response rate to BMS-986523 and how long that response lasts based on RECIST v1.1 as judged by the study doctor., How BMS-986523 moves through and is processed by the body, including the highest level of the drug in the blood (Cmax), how long it takes to reach that level (Tmax), and overall exposure (AUC), based on blood tests over time.

Interventions

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
How often side effects occur, including serious ones, side effects that meet study rules for a dose-limiting toxicity, and side effects that make people stop study treatment or cause death.

Secondary

MeasureTime frame
Overall response rate to BMS-986523 and how long that response lasts based on RECIST v1.1 as judged by the study doctor., How BMS-986523 moves through and is processed by the body, including the highest level of the drug in the blood (Cmax), how long it takes to reach that level (Tmax), and overall exposure (AUC), based on blood tests over time.

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 10, 2026