Study on BI-1910 Alone and with Pembrolizumab for Treating Advanced Solid Tumors

Sponsor: BioInvent International AB

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06205706

Provider View

This clinical trial is testing a new drug, BI-1910, both by itself and with another drug, pembrolizumab, to see if it is safe and effective for people with advanced solid tumors that have not responded to standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out if BI-1910, a new drug, is safe and well-tolerated when given alone or with pembrolizumab to patients with advanced solid tumors that have worsened after standard treatments. The study will also determine the best dose to use in future research. Participants will receive the treatment every three weeks.

Description

This study is in its early stages and is divided into two main parts: Phase 1 and Phase 2a.

In Phase 1, the study will test different doses of BI-1910 alone (Part A) and with pembrolizumab (Part B) to find the safest and most effective dose.

In Phase 2a, the study will further evaluate the safety and effectiveness of BI-1910 alone (Part A) and with pembrolizumab (Part B) at the doses determined in Phase 1. The study will also look at how the drug behaves in the body and its preliminary effects on tumors.

Participants will receive the treatment every three weeks and will be monitored for side effects and how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Must be willing and able to sign a consent form to participate.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of advanced or metastatic solid tumor.
  • Must have tried standard treatments and either not responded, cannot tolerate them, or are not eligible for them.
  • Must have at least one tumor that can be measured.
  • Must be willing to provide tumor samples as required.
  • Must have a life expectancy of at least 12 weeks.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have adequate organ function as shown by lab tests.

Exclusion Criteria

  • Cannot take more than 10 mg of prednisolone or equivalent steroids daily during the trial.
  • Cannot have active cancer spread to the brain or spinal cord.
  • Cannot have allergies to BI-1910 or pembrolizumab.
  • Cannot have certain heart or kidney conditions.
  • Cannot have had recent chemotherapy, radiation, or immunotherapy within specified timeframes before starting the study.
  • Cannot have severe side effects from previous treatments that have not improved.
  • Cannot have a history of severe autoimmune reactions to similar treatments.
  • Cannot have a history of lung inflammation requiring steroids.
  • Cannot have active autoimmune diseases.
  • Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control.
  • Men with partners who can become pregnant must agree to use condoms and effective birth control.
  • Cannot have had major surgery without full recovery.
  • Cannot have serious infections or other major health issues.
  • Cannot have had a tissue or organ transplant.
  • Cannot have HIV, chronic hepatitis B or C, or active tuberculosis.
  • Cannot have received a live vaccine recently.
  • Cannot have uncontrolled heart disease.
  • Cannot have mental health or substance abuse issues that affect participation.
  • Cannot be in another clinical trial or have used investigational treatments recently.
  • Cannot have another type of cancer, except for certain treated skin cancers or prostate cancer under specific conditions.
  • Cannot have immune system disorders or be on immunosuppressive therapy recently.

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