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A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants with Advanced Solid Tumors

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503651-10-00
Acronym
CA052-002
Enrollment
163
Registered
2023-08-11
Start date
2022-05-17
Completion date
Unknown
Last updated
2025-12-04

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

Conditions

Male and female participants ≥ 18 years of age with advanced or metastatic cancers

Brief summary

Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death

Detailed description

Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel, Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab or docetaxel, ORR, DCR, DOR, and PFSR

Interventions

DRUGAnti-CCR8 NF mAb
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death

Secondary

MeasureTime frame
Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel, Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab or docetaxel, ORR, DCR, DOR, and PFSR

Countries

Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026