PRO1107 in Patients With Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, PK, and antitumor activity of PRO1107 in patients with advanced solid tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion.

Clinical Trial Description

This is a Phase 1/2 study of PRO1107, a PTK7 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1107 in patients with advanced solid tumors, including ovarian cancer, endometrial cancer, triple negative breast cancer, non-small cell lung cancer, gastroesophageal cancer, and urothelial cancer. This study consists of 2 parts, Part A: Dose Escalation and Part B: Dose Expansion. Part A may evaluate up to 7 dose levels of PRO1107 on Day 1 of a 21 day cycle by IV infusion. Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, PD and activity data from Part A in up to 4 different cohorts of up to 40 patients per cohort. 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

Clinical Trial Details

NCT number	NCT06171789
Study type	Interventional
Source	ProfoundBio US Co.
Contact	ProfoundBio Trial Support
Phone	1-844-774-4232
Email	clinicaltrialinfo@profoundbio.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	January 29, 2024
Completion date	February 2027

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