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A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

ConditionsCervical CancerGastric/Gastroesophageal Junction AdenocarcinomaMicrosatellite Stable Colorectal CancerNon-Small-Cell Lung CancerSquamous Cell Carcinoma of Head and NeckCarcinoma, Renal CellUrothelial CarcinomaPancreatic AdenocarcinomaMelanomaOvarian NeoplasmsTriple Negative Breast Neoplasms
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 assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.

Eastern Cooperative Oncology Group Performance Status of 0 or 1.

Radiographically documented progressive disease on or after the most recent therapy.

Disqualifiers

Women who are pregnant or breastfeeding.

Primary central nervous system (CNS) malignancy.

Untreated CNS metastases.

Leptomeningeal metastases.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BMS-986340

    Drug

    Specified dose on specified days

  • BMS-936558-01

    Drug

    Specified dose on specified days

  • Docetaxel

    Drug

    Specified dose on specified days

  • Pumitamig

    Drug

    Specified dose on specified days

Treatment groups

1,109 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Part 1A: BMS-986340 Dose EscalationExperimental treatment 1 intervention
Group B: Part 2A: BMS-986340 Dose ExpansionExperimental treatment 1 intervention
Group C: Part 1B: BMS-986340 + Nivolumab Dose EscalationExperimental treatment 2 interventions
Group D: Part 2B: BMS-986340 + Nivolumab Dose ExpansionExperimental treatment 2 interventions
Group E: Part 1C: BMS-986340 + Docetaxel Dose EscalationExperimental treatment 2 interventions
Group F: Part 1A-J: BMS-986340 Dose EscalationExperimental treatment 1 intervention
Group G: Part 1B-J: BMS-986340 + Nivolumab Dose EscalationExperimental treatment 2 interventions
Group H: Part 2C: BMS-986340 + Docetaxel Dose ExpansionExperimental treatment 2 interventions
Group I: Part 2D: BMS-986340 + Pumitamig Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Time frame
Up to 120 weeks
2

Incidence of serious adverse events (SAEs)

Time frame
Up to 120 weeks
3

Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

Time frame
Up to either 21 or 28 days
4

Incidence of AEs leading to discontinuation

Time frame
Up to 120 weeks

Secondary outcomes

1

Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)

Time frame
Up to 120 weeks
2

PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)

Time frame
Up to 120 weeks
3

PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))

Time frame
Up to 120 weeks
4

PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)

Time frame
Up to 120 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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