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Closed (no longer recruiting)Last updated: 24 January 2024

BMS-986148: This phase I trial is evaluating two drugs (BMS-986148 and nivolumab) alone and in combination for the treatment of select advanced cancersA Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors

Clinical summary

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-896148 in subjects with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.

Conditions

This trial is treating patients with Mesothelioma, Non Small Cell Lung Cancer, Ovarian, Pancreatic, Stomach (Gastric).

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 75

Phase

I

Trial Acronym

BMS-986148

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors

Eligibility

Inclusion

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

  • Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
  • Expected to have life expectancy of at least 3 months
  • Men and women 18 years old or older (or local age of majority)
  • Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
  • ECOG of 0 to 1

Exclusion

  • Cancer metastases in the brain
  • Moderate eye disorders
  • Active infection or past hepatitis B or C infection
  • Major surgery less than 1 month before the start of the study
  • Uncontrolled heart disease
  • Impaired liver or bone marrow function
  • History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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