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A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics,and Efficacy of BMS-986369 (Golcadomide)in Participants with Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

A Phase 1/2 Study of BMS-986369(Golcadomide)in Participants with Relapsed or Refractory T-cell Lymphomasin Japan (CA0731008)

Naka Ryosuke

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Naka Ryosuke

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Not Recruiting

Sept. 27, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Have T-cell Lymphoma with relapsed or refractory disease, as assessed by the investigator
- Phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or
for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator.
- Phase 2 participants must have been treated by at least 1 prior line of systemic therapy.
- Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2.

- Have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in
the study.
- Have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study.
- Have a life expectancy <=3 months.

Both

Relapsed or Refractory T-cell Lymphoma

Drug: BMS-986369(Other Names:Golcadomide/CC-99282)
Specified dose on specified days

Phase 1: To assess the safety and tolerability and establish the RP2D of BMS-986369 in participants with R/R TCL.
Phase 2 (ATL cohort): To assess the efficacy of BMS-986369 in participants with R/R ATL.
Phase 2 (PTCL cohort): To assess the efficacy of BMS-986369 in participants with R/R PTCL.

- To characterize the PK of BMS-986369 in participants with R/R TCL.
- To assess the preliminary efficacy of BMS-986369 in participants with R/R TCL.
- To assess the safety and tolerability of BMS-986369 in participants with R/R ATL and R/R PTCL.
- To characterize the PK of BMS-986369 in participants with R/R ATL and R/R PTCL.
- To assess the efficacy parameters of BMS-986369 including ORR (investigator assessment), DCR, CR rate, TTR, DOR, PFS, TTNT, and OS in participants with R/R ATL and R/R PTCL.

+81-86-223-7151

Aug. 16, 2023

No

none