Study on BI-1808 Alone and with Pembrolizumab for Treating Advanced Cancers

Sponsor: BioInvent International AB

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04752826

Provider View

This clinical trial is testing a new drug, BI-1808, both by itself and with another drug, pembrolizumab, to see if it can help treat advanced cancers that have not responded to standard treatments.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a new treatment, BI-1808, alone and in combination with pembrolizumab, for patients with advanced cancers, including certain skin lymphomas. The trial is divided into two phases, with the first phase focusing on finding the right dose and the second phase expanding the study to more patients. Participants will have regular follow-ups and a final visit 30 days after their last treatment.

Description

This clinical trial is testing a new drug called BI-1808, both on its own and with another drug, pembrolizumab, in people with advanced cancers that have not improved with standard treatments. The study is divided into two main parts: Phase 1 and Phase 2a.

In Phase 1, the study will test different doses of BI-1808 to find the safest and most effective dose. This phase includes two parts: Part A, where BI-1808 is given alone, and Part B, where it is combined with pembrolizumab. Participants will receive the drug every three weeks and will be closely monitored for side effects and how well the treatment is working.

In Phase 2a, the study will expand to include more patients and will continue to test the effectiveness of BI-1808, both alone and with pembrolizumab, in specific types of cancer, such as non-small cell lung cancer (NSCLC) and ovarian cancer (OC). Participants will continue to receive the treatment every three weeks and will be monitored for any benefits or side effects.

Throughout the study, participants will have regular check-ups and tests to assess their health and the impact of the treatment. If the cancer shows signs of improvement, participants may continue the treatment for up to 32 additional doses, unless the cancer progresses or side effects become too severe.

Eligibility Criteria

Inclusion Criteria

  • Must be willing and able to provide written consent to participate.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of advanced cancer.
  • Must have tried standard cancer treatments without success or be unable to receive them.
  • Must have at least one measurable tumor.
  • Must be able to safely undergo a tumor biopsy before starting the study.
  • Must have a life expectancy of at least 12 weeks.
  • Must have a good performance status (ECOG 0-1).
  • Must have adequate organ function based on lab tests.

Additional criteria for Phase 2:

For NSCLC (Cohorts 1 and 4):

  • Must have received prior anti-PD-1 therapy and possibly chemotherapy, depending on PD-L1 status.
  • Must have received targeted therapy if specific genetic mutations are present.

For OC (Cohorts 2 and 5):

  • Must have recurrent ovarian, fallopian tube, or peritoneal cancer.
  • Must have cancer that is resistant or refractory to platinum-based chemotherapy.
  • Must have received at least one line of platinum-based chemotherapy.

For CTCL (Cohort 3):

  • Must have stage IB-IV MF or SS with failure of at least one systemic therapy.
  • Must not have large cell transformation.
  • Must not have had a recent stem cell transplant.
  • Must be on stable doses of steroids if applicable.

Exclusion Criteria

  • Cannot require more than 10 mg of prednisolone daily.
  • Cannot have active brain metastases or meningitis.
  • Cannot have allergies to BI-1808 or pembrolizumab.
  • Cannot have certain heart or kidney conditions.
  • Cannot have received recent chemotherapy, radiation, or immunotherapy.
  • Cannot have unresolved side effects from previous treatments.
  • Cannot have severe autoimmune reactions to previous treatments.
  • Cannot have a history of lung inflammation requiring steroids.
  • Cannot have active autoimmune diseases.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had major surgery recently.
  • Cannot have severe infections or other serious health conditions.
  • Cannot have a history of organ transplant or certain infections like HIV or hepatitis.
  • Cannot have received a live vaccine recently.
  • Cannot have uncontrolled heart disease or mental health issues.
  • Cannot be participating in another clinical trial or have another active cancer.

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