Clinical Trial Radar

Here's an explanation of the clinical trial NCT06764771:

Understanding Trial NCT06764771: Investigating BMS-986488 for Advanced Malignant Tumors

This clinical trial, identified as NCT06764771, is an early-phase study designed to explore a new experimental drug called BMS-986488 for individuals with advanced malignant tumors.

🎯 Purpose of the Study

The primary goal of this Phase 1 study is to determine if BMS-986488, when given alone (as monotherapy) or in various combinations with other anti-cancer drugs, is safe and tolerable for patients. Researchers also want to see if it shows any initial signs of anti-cancer activity.

🔬 The Investigational Treatment: BMS-986488

BMS-986488 is an investigational drug, meaning it's still in the research phase and not yet approved for general use. In this trial, it's being tested in several ways:

• Monotherapy: BMS-986488 by itself.
• Combination Therapies:
  • BMS-986488 with Adagrasib
  • BMS-986488 with Adagrasib and Cetuximab
  • BMS-986488 with Nivolumab

These combinations are designed to target different pathways involved in cancer growth, with Adagrasib, for example, specifically targeting tumors with a KRAS G12C mutation.

🧪 Study Design

This is a Phase 1, interventional, non-randomized, sequential study with no masking (meaning both patients and researchers know which treatment is being given).

• Phase 1: This is the earliest stage of human testing. The main focus is on finding a safe dose, understanding how the drug behaves in the body (pharmacokinetics), and identifying potential side effects. Efficacy (how well it treats the cancer) is a secondary consideration at this stage.
• Interventional: Participants receive specific interventions (the study drugs) according to the protocol.
• Non-Randomized: Participants are not randomly assigned to different treatment groups. Instead, they are typically assigned based on specific criteria or sequentially as the study progresses.
• Sequential: This often means that different groups of patients receive the treatment in a specific order, perhaps with dose escalation or different combinations being tested in sequence.

The study aims to enroll approximately 437 participants and is currently recruiting.

✅ Participation and Eligibility

To be eligible for this trial, participants must be at least 18 years old and have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy. The specific tumor types vary depending on the "part" of the study:

• Part 1A, 2A, 1D, 2D: 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).
• Part 1B, 2B: Solid tumors or NSCLC with a KRAS G12C mutation.
• Part 1C, 2C: Colorectal cancer (CRC) with a KRAS G12C mutation.

Participants must also have a good general health status, indicated by an ECOG Performance Status of 0 or 1, and have measurable disease.

Exclusion criteria include untreated central nervous system (CNS) metastases, impaired cardiac function, and, for combinations involving Adagrasib, a history of pneumonitis or severe skin reactions.

📢 Please check the Trial Radar Card View 'Participation' tab for complete Eligibility details, as other protocol-defined criteria apply.

📊 Outcomes Being Measured

The study will measure several outcomes to assess the safety and potential effectiveness of BMS-986488:

• Primary Outcomes (Safety & Tolerability):

  • Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs).
  • Number of participants with Dose-Limiting Toxicities (DLTs), which are side effects severe enough to limit the amount of drug that can be given.
  • Number of participants who discontinue treatment due to AEs.
  • Number of deaths.

• Secondary Outcomes (Efficacy & Pharmacokinetics):

  • Objective Response Rate (ORR): The proportion of participants whose tumors shrink or disappear (complete or partial response).
  • Disease Control Rate (DCR): The proportion of participants whose disease either shrinks, disappears, or remains stable.
  • Duration of Response (DOR): How long the anti-cancer effect lasts.
  • Pharmacokinetic measures: Such as Cmax (maximum drug concentration in blood), Tmax (time to reach Cmax), and AUC (overall drug exposure), which help understand how the body processes the drug.

📢 Check the Trial Radar Card View 'Study Plan' tab for complete Outcome details.

💡 Why This Trial is Important

This study is crucial for several reasons:

• It's an early step in evaluating a new potential cancer treatment, BMS-986488.
• It explores both single-agent activity and the potential benefits of combining BMS-986488 with other established or investigational therapies.
• By specifically targeting tumors with the KRAS G12C mutation in some arms, it aims to develop more personalized and effective treatments for certain cancer types.

The lead sponsor for this study is Bristol-Myers Squibb, and it is being conducted at sites in the United States, Australia, and Canada.

💬 If you or someone you know is considering participating in a clinical trial, it is always recommended to discuss it thoroughly with your healthcare provider. They can help determine if a trial is appropriate for your specific situation. You can find more details about this study on the Trial Radar Card, including information on the study plan, eligibility, and contacts.

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