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An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant must be at least 18 years of age or the age of maturity per local regulations
• Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \[HER2\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.
• Archival tissue sample for testing
• Measurable disease
• Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Have adequate bone marrow and organ function.
• Able to comply with contraceptive/barrier requirements
Locations
United States
Colorado
Sarah Cannon Research Institute at HealthONE
RECRUITING
Denver
Florida
Florida Cancer Specialists
RECRUITING
Sarasota
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
New York
START New York Long Island, LLC
RECRUITING
Lake Success
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
NEXT Texas LLC - Austin
RECRUITING
Austin
START Dallas Fort Worth, LLC
RECRUITING
Fort Worth
MD Anderson
RECRUITING
Houston
NEXT Texas LLC - Houston
RECRUITING
Houston
NEXT Texas LLC - Dallas
RECRUITING
Irving
NEXT Texas LLC - San Antonio
RECRUITING
San Antonio
START San Antonio, LLC
RECRUITING
San Antonio
Utah
START Mountain Region, LLC
RECRUITING
West Valley City
Virginia
NEXT Texas LLC - Virginia
RECRUITING
Fairfax
Washington
Medical Oncology Associates
RECRUITING
Spokane
Contact Information
Primary
IDEAYA Clinical Trials
IDEAYAClinicalTrials@ideayabio.com
1-855-433-2246
Time Frame
Start Date:2026-02-24
Estimated Completion Date:2027-07-30
Participants
Target number of participants:150
Treatments
Experimental: Part 1:IDE034 Dose Escalation
IDE034 Dose Escalation Successive cohorts of participants will be treated with increasing doses of IDE034 until the maximum tolerated dose or the recommended dose for expansion is determined
Experimental: Part 2: IDE034 Dose Expansion
IDE034 Dose Expansion To further assess the safety, tolerability, and preliminary antitumor activity at one or more dose levels of IDE034 selected from dose escalation