RightFit
RecruitingPhase 1

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an experimental drug called BMS-986488, alone or with other drugs, in adults with certain advanced cancers. It looks at whether treatment is safe, how well people handle it, and whether it fights cancer.

This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18 or older.
  • A tissue test must confirm a solid tumor that has spread nearby and cannot be removed by surgery, or has spread to other parts of the body.
  • Part 1A accepts clear-cell kidney cancer, clear-cell ovarian cancer, non-small cell lung cancer, colorectal cancer, or pancreatic ductal cancer.
  • Parts 2A, 1D, and 2D accept clear-cell kidney cancer only.
  • Part 1B accepts solid tumors with a gene change called KRAS G12C.
  • Part 2B accepts non-small cell lung cancer with KRAS G12C. Parts 1C and 2C accept colorectal cancer with this gene change.
  • You must be fully active or able to do light work, even if hard physical activity is limited.
  • Your cancer must be measurable using the study's standard rules.

Who can't join

  • Cancer has spread to your brain or spinal cord and has not been treated.
  • Cancer has spread to the lining around your brain and spinal cord.
  • Your heart does not work well, or you have significant heart disease.
  • For parts using adagrasib (1B, 1C, 2B, and 2C): you have a history of lung inflammation or interstitial lung disease, which can cause lung scarring.
  • For parts using adagrasib: you have had a severe skin reaction, including Stevens-Johnson syndrome or toxic epidermal necrolysis.
  • Other study rules may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participant must be ≥ 18 years of age. * Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. * Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). * Parts 2A, 1D, 2D: ccRCC. i) Part 1B: solid tumors with KRAS G12C mutation. ii) Part 2B: NSCLC with KRAS G12C mutation. iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation. * Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1. * Participants must have measurable disease per RECIST v1.1. Exclusion Criteria: * Untreated central nervous system (CNS) metastases. * Leptomeningeal metastasis (carcinomatous meningitis). * Impaired cardiac function or clinically significant cardiac disease. * For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):. i) History of pneumonitis or interstitial lung disease (ILD). ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). \- Other protocol-defined inclusion/exclusion criteria apply.

Study sites (4)

NJ

PA

TN

TX