Testing BI-1808 alone and with pembrolizumab for advanced cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of BI-1808, both as a single agent and in combination with pembrolizumab, in patients with advanced malignancies that have progressed after standard therapies. The study is structured in two phases: Phase 1 focuses on dose escalation to determine the maximum tolerated dose and safety profile, while Phase 2a will assess the drug's effectiveness and safety at the recommended doses. Participants will receive infusions every three weeks, and the study will include various cohorts based on specific cancer types.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able and willing to provide written informed consent.
* Aged 18 years or older.
* Histologically confirmed advanced or metastatic malignancy eligible for an enrolling study cohort.
* Disease progression following, intolerance of, ineligibility for, or refusal of applicable standard therapy.
* At least one measurable lesion according to the response criteria specified in the protocol.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Life expectancy of at least 12 weeks.
* Adequate organ function.
* Willing and medically suitable to provide required tumor or skin biopsies.
* Meets the disease-specific and treatment-history requirements of the applicable Phase 2a cohort.
* For Phase 2a Part C: Histologically confirmed platinum-resistant high-grade serous or clear-cell ovarian carcinoma, prior platinum-based treatment as specified in the protocol, and suitability for paclitaxel treatment.

Exclusion Criteria:

1\. Active central nervous system metastases or carcinomatous meningitis.

* Active or clinically significant autoimmune disease, immunodeficiency, or use of prohibited immunosuppressive treatment.
* Prior treatment-related toxicity not recovered to the level specified in the protocol.
* Prior anticancer therapy, radiotherapy, immunotherapy, investigational treatment, or live vaccine within the protocol-defined washout period.
* History of clinically significant immune-mediated toxicity, including pneumonitis, associated with previous immune-checkpoint inhibitor treatment.
* Uncontrolled or clinically significant cardiovascular disease, serious infection, or another condition that could compromise safety or study participation.
* Major surgery without adequate recovery.
* Prior allogeneic tissue or solid-organ transplantation or active graft-versus-host disease.
* Pregnancy or breastfeeding, or unwillingness to comply with protocol-defined contraceptive requirements.
* Known hypersensitivity to a study treatment or its components.
* Another active malignancy, except for protocol-defined permitted malignancies.
* Participation in another interventional clinical trial that conflicts with this study.
* Unable or unlikely to comply with study procedures and requirements.
* For Phase 2a Part C: Receipt of prohibited colony-stimulating factors within the protocol-defined period before treatment.

Where it's running

• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Herlev Hospital
  Herlev, Denmark Recruiting
• Magyar Honvédség-Egészségügyi Központ
  Budapest, Hungary Recruiting

Study contacts

• Study coordinator: Susanne Gertsson
• Email: susanne.gertsson@bioinvent.com
• Phone: +46462868550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.