Study of BI-1206 with Pembrolizumab for Advanced Solid Tumors (KEYNOTE-A04)

Sponsor: BioInvent International AB

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04219254

Provider View

This clinical trial is testing a new treatment combining BI-1206, a monoclonal antibody, with pembrolizumab in patients with advanced solid tumors who have previously been treated with certain immune therapies.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced solid tumors using BI-1206, a monoclonal antibody, in combination with pembrolizumab. The trial is for patients who have already received treatments targeting PD-1 or PD-L1 proteins but need further options. The study aims to find the best dose and assess the effectiveness of this combination therapy.

Description

The trial is divided into two main parts:

  • Phase 1: This part will test different doses of BI-1206, given either through an IV (intravenous) or under the skin (subcutaneous), to find the safest and most effective dose.

  • Phase 2a: This part will expand the study to include more patients with specific types of advanced solid tumors, such as non-small-cell lung cancer and metastatic melanoma, to further evaluate the treatment's effectiveness.

Participants will initially receive three cycles of the combination therapy. If they show benefits from the treatment at the nine-week mark, they may continue receiving the therapy every three weeks for up to two years or until the cancer progresses.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced solid tumor.
  • Previously treated with at least two doses of PD-1/PD-L1 therapy and experienced cancer progression.
  • Unable to undergo standard cancer treatments or have chosen not to.
  • Have at least one measurable tumor.
  • Able to safely undergo a tumor biopsy before starting the study treatment.
  • Have a life expectancy of at least 12 weeks.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate organ function based on lab tests.

Specific Criteria for Cohorts:

  • Cohort 1 (Non-small cell lung cancer):

    • Tumors with PD-L1 ≥ 50%: Must have had prior anti-PD-1 therapy.
    • Tumors with unknown or PD-L1 < 50%: Must have had prior anti-PD-1/PD-L1 therapy and chemotherapy.
    • Known genetic mutations: Must have had targeted therapy in addition to anti-PD-1/PD-L1 therapy.

  • Cohort 2 (Metastatic Melanoma):

    • Must have had prior anti-PD-1 therapy.
    • Known BRAF mutation: Must have had combination targeted therapy.

  • Cohort 3 (Other Tumor Types):

    • Must have had prior anti-PD-1/PD-L1 therapy.

Exclusion Criteria

  • Need for high doses of steroids (more than 10 mg of prednisolone daily).
  • Active cancer spread to the brain or spinal cord.
  • Allergies to pembrolizumab or BI-1206.
  • Certain heart or kidney conditions.
  • Recent chemotherapy, radiation, or immunotherapy.
  • Unresolved side effects from previous cancer treatments.
  • Severe autoimmune reactions to past treatments.
  • History of lung inflammation requiring steroids.
  • Active autoimmune diseases.
  • Women who are pregnant or breastfeeding.
  • Men with partners who can become pregnant.
  • Recent major surgery.
  • Severe infections or other serious health conditions.
  • History of organ transplant or chronic graft versus host disease.
  • HIV or hepatitis B/C infections.
  • History of tuberculosis.
  • Recent live vaccinations.
  • Uncontrolled heart disease.
  • Mental health or substance abuse issues affecting study participation.
  • Participation in another clinical trial within the last four weeks.
  • Other active cancers or immune system disorders.

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