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Clinical Trial Summary

This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).


Clinical Trial Description

This is a Phase 1/2 study of PRO1184, a folate receptor alpha (FRĪ±) targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1184 in patients with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma. The study consists of 4 main parts: Part A: dose-escalation cohorts Part B: tumor-specific monotherapy dose-expansion cohorts Part C: ovarian cancer extension cohort Part D: combination therapy cohorts Patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05579366
Study type Interventional
Source ProfoundBio US Co.
Contact ProfoundBio Trial Support
Phone 1-844-774-4232
Email PRO1184-001@profoundbio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date December 7, 2022
Completion date April 2026

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