A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.

Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Participants must have a life expectancy of at least 3 months at the time of the first dose.

Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed

Disqualifiers

Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.

Participants with known mutations in EGFR will be excluded (Group A,B and E).

Participants must not have a history of serious recurrent infections.

Participants must not have a history of severe heart disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • BMS-986507

    Drug

    Specified dose on specified days

  • Osimertinib

    Drug

    Specified dose on specified days

  • Pembrolizumab

    Drug

    Specified dose on specified days

  • Nivolumab

    Drug

    Specified dose on specified days

  • Pumitamig

    Drug

    Specified dose on specified days

Treatment groups

416 Participants
are divided into 5 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Group C: Group CExperimental treatment 2 interventions
Group D: Group DExperimental treatment 2 interventions
Group E: Group EExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to 3 years
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to 3 years
3

Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera

Time frame
Up to 3 years
4

Number of participants with AEs leading to discontinuation

Time frame
Up to 3 years

Secondary outcomes

1

Maximum observed serum concentration (Cmax)

Time frame
Up to 3 years
2

Time of maximum observed concentration (Tmax)

Time frame
Up to 3 years
3

Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

Time frame
Up to 3 years
4

Area under the serum concentration-time curve within a dosing interval (AUC(TAU))

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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