PRO1107 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ProfoundBio US Co.

Criteria

Inclusion Criteria

• Pathologically confirmed diagnosis of one of the following tumor types:

• Ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer)

• Endometrial cancer (any subtype excluding sarcoma)

• Triple negative breast cancer (TNBC)

• Non-small cell lung cancer (NSCLC)

• Gastric or gastroesophageal junction (GEJ) adenocarcinoma

• Esophageal squamous cell carcinoma (ESCC)

• Urothelial cancers (bladder, ureter, or renal pelvis)

• Metastatic or unresectable locally advanced, recurrent, disease not amenable to further local therapy following prior systemic therapies known to confer clinical benefit. Measurable disease at baseline as defined per RECIST, Version 1.1 (Eisenhauer et al. 2009)

• Willing to provide a pre-treatment tumor specimen (archival or fresh biopsy samples).

• ECOG performance status score 0 or 1.

Exclusion Criteria

• Prior treatment with anti-PTK7 directed therapy.

• Had progressive disease as best response while on treatment with an auristatin (vedotin, pelidotin)-based antibody drug conjugate (ADC) as the most recent line of therapy.

• Other malignancy within 3 years

• Active CNS metastases (treated, stable CNS metastases are allowed)

• Uncontrolled infection within 2 weeks.

• Positive for HBV, HCV or HIV

• Use of a strong P450A CYP3A inhibitor within 2 weeks

• Additional protocol defined inclusion/exclusion criteria may apply