PRO1107 in Patients With Advanced Solid Tumors
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.
Conditions:
🦠 Endometrial Cancer 🦠 Ovarian Cancer 🦠 Triple Negative Breast Cancer 🦠 GastroEsophageal Cancer 🦠 Non-small Cell Lung Cancer 🦠 Urothelial Carcinoma
🗓️ Study Start (Actual) 29 January 2024
🗓️ Primary Completion (Estimated) February 2027
✅ Study Completion (Estimated) February 2027
👥 Enrollment (Estimated) 214
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Scottsdale, Arizona, United States
📍 Boston, Massachusetts, United States
📍 Houston, Texas, United States
📍 Salt Lake City, Utah, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 November 2023
  • First Submitted that Met QC Criteria 6 December 2023
  • First Posted 15 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 April 2024
  • Last Update Posted 16 April 2024
  • Last Verified April 2024