A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
Start Date
2/24/2026
Completion Date
7/30/2027
Summary
This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.
Detailed Description
Part 1 - Dose escalation Part 1 will evaluate increasing doses of IDE034 to assess safety, tolerability, and to determine dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in subjects with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7. Part 2 - Dose Expansion Part 2 will evaluate participants with B7-H3 and PTK7 expressing advanced/metastatic solid tumors at 2 or more dose levels determined to be safe and tolerable during dose escalation. The goal of Part 2 is to identify which of the doses evaluated in Part 1 is safe, well tolerated and results in tumor responses. In parallel a basket cohort may be enrolled at one of the expansion dose(s) for which the tumor types and other selection criteria will be based on emerging data from nonclinical and Part 1 clinical evaluations. Additional selection criteria may be applied to the expansion indications (e.g., histological subset or select molecular alterations) based on emerging data.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
IDE034
Conditions
Locations
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
Florida Cancer Specialists
Sarasota, Florida 34232
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
START New York Long Island, LLC
Lake Success, New York 11042
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
NEXT Texas LLC - Austin
Austin, Texas 78758
United States
START Dallas Fort Worth, LLC
Fort Worth, Texas 76104
United States
MD Anderson
Houston, Texas 77030
United States
NEXT Texas LLC - Houston
Houston, Texas 77054
United States
NEXT Texas LLC - Dallas
Irving, Texas 75039
United States
NEXT Texas LLC - San Antonio
San Antonio, Texas 78229
United States
START San Antonio, LLC
San Antonio, Texas 78229
United States
START Mountain Region, LLC
West Valley City, Utah 84119
United States
NEXT Texas LLC - Virginia
Fairfax, Virginia 22031
United States
Medical Oncology Associates
Spokane, Washington 99208
United States