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NCT Number: NCT04895709

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

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.

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Key information

Conditions

Cervical Cancer Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric/Gastroesophageal Junction Adenocarcinoma Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Microsatellite Stable Colorectal Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Small-Cell Lung Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Adenocarcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Blacktown Hospital, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
  • Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.

Exclusion criteria

  • Women who are pregnant or breastfeeding.
  • Primary central nervous system (CNS) malignancy.
  • Untreated CNS metastases.
  • Leptomeningeal metastases.
  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.
  • Active, known, or suspected autoimmune disease.
  • Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
  • Prior organ or tissue allograft.
  • Uncontrolled or significant cardiovascular disease.
  • Major surgery within 4 weeks of study drug administration.
  • History of or with active interstitial lung disease or pulmonary fibrosis.
  • Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986340

Drug

Specified dose on specified days

BMS-936558-01

Drug

Specified dose on specified days

Other names: Nivolumab

docetaxel

Drug

Specified dose on specified days

Pumitamig

Drug

Specified dose on specified days

Other names: BMS-986545, BNT327

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

  5. Number of deaths

    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

  5. PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)

    Time frame: Up to 120 weeks

  6. PK parameters of BMS-986340 administered in combination with docetaxel: Cmax

    Time frame: Up to 120 weeks

  7. PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)

    Time frame: Up to 120 weeks

  8. PK parameters of BMS-986340 administered in combination with docetaxel: Tmax

    Time frame: Up to 120 weeks

  9. PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Time frame: Up to 120 weeks

  10. PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)

    Time frame: Up to 120 weeks

  11. PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)

    Time frame: Up to 120 weeks

  12. PK parameters of BMS-986340 administered in combination with docetaxel: Ctau

    Time frame: Up to 120 weeks

  13. PK parameters of BMS-986340 administered in combination with pumitamig: Cmax

    Time frame: Up to 120 weeks

  14. PK parameters of BMS-986340 administered in combination with pumitamig: Tmax

    Time frame: Up to 120 weeks

  15. PK parameters of BMS-986340 administered in combination with pumitamig: AUC(TAU)

    Time frame: Up to 120 weeks

  16. PK parameters of BMS-986340 administered in combination with pumitamig: Ctau

    Time frame: Up to 120 weeks

  17. Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy

    Time frame: Up to 120 weeks

  18. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab

    Time frame: Up to 120 weeks

  19. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel

    Time frame: Up to 120 weeks

  20. Incidence of anti-drug antibodies to BMS-986340 when administered in combination with pumitamig

    Time frame: Up to 120 weeks

  21. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Time frame: At 6 months, 12 months

  22. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Time frame: At 6 months, 12 months

  23. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Time frame: At 6 months, 12 months

  24. Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator

    Time frame: At 6 months, 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
May 20, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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