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  • NCT06997029

Not Yet Recruiting

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors - CA243-0001

Opdateret: 21 maj, 2025   |   ClinicalTrials.gov

Udskriftsvenligt sammendrag

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Udskriv denne side CA243-0001
Hente vejledningen til forsøgsdeltagere

VÆLG SPROG

Forsøgsdetaljer

  • Phase 1

    Fase

  • Køn

  • 18+

    Aldersinterval

  • 13

    Beliggenhed(er)

  • Not Yet Recruiting

Behandlingsmuligheder

Forsøgsgrene
TILDELT INTERVENTION
Experimental: Part 1A Monotherapy Dose Escalation
Drug: BMS-986500
Experimental: Part 1B Combination Dose Escalation
Drug: BMS-986500, Palbociclib, Fulvestrant
Experimental: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study
Drug: BMS-986500
Experimental: Part 2A Monotherapy Dose Expansion
Drug: BMS-986500
Experimental: Part 2B Combination Dose Expansion
Drug: BMS-986500, Palbociclib, Fulvestrant

Primære egnethedskriterier

Inclusion Criteria: - Participants must be ≥ 18 years of age. - Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy. - Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1. - For Part 2A only, participants must have CCNE1-amplified ovarian cancer Exclusion Criteria: - Participants must not have an active brain metastasis. - Participants must not have impaired cardiac function or clinically significant cardiac disease. - Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months. - Participants must not have Grade ≥ 2 peripheral neuropathy. - Other protocol-defined Inclusion/Exclusion criteria apply.

Hvis du vil rapportere en bivirkning, kan du indberette direkte til Lægemiddelstyrelsen via hjemmesiden www.meldenbivirkning.dk
Vi anbefaler at du også kontakter BMS for at rapportere bivirkninger.
Bivirkninger og andre rapporterbare begivenheder er defineret her
Rapporter bivirkninger eller klager over produktkvalitet: Medicinsk information

466-DK-2200001