PRO1107 for Advanced Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use a strong P450A CYP3A inhibitor within 2 weeks before joining.
What makes the drug PRO1107 unique for treating advanced cancer?
What is the purpose of this trial?
This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1107 (PRO1107) in participants with advanced solid tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion.
Research Team
Study Official
Principal Investigator
Genmab
Eligibility Criteria
This trial is for adults with certain advanced solid tumors, including specific types of breast, ovarian, endometrial, gastroesophageal, bladder cancer and non-small cell lung cancer. Participants must have measurable disease after prior treatments and be in good physical condition (ECOG score 0 or 1). They also need to provide a tumor sample.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Part A: Evaluation of up to 7 dose levels of PRO1107 on Day 1 of a 21-day cycle by IV infusion
Dose Expansion
Part B: Initiation at a dose level based on analysis from Part A in up to 4 different cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- PRO1107
Find a Clinic Near You
Who Is Running the Clinical Trial?
ProfoundBio US Co.
Lead Sponsor
Genmab
Lead Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen