A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- IDEAYA Biosciences
- Study ID
- NCT07503808
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Castration-resistant Prostate Cancer
- Colorectal Cancer
- Endometrium Cancer
- Esophageal Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- High Grade Serous Ovarian Cancer
- Non Small Cell Lung Cancer
- Triple Negative Breast Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IDE034 — DRUGIDE034
Study Details
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.
Key Dates
- First listed
- Mar 31, 2026
- Start date
- Feb 24, 2026
- Status verified
- Mar 2026
- Primary completion
- Jul 30, 2027
- Completion
- Jul 30, 2027
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1:IDE034 Dose EscalationIDE034 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 ExpansionIDE034 Dose Expansion To further assess the safety, tolerability, and preliminary antitumor activity at one or more dose levels of IDE034 selected from dose escalation
Primary Outcome Measure
Safety and tolerability of IDE034 in Part 1 dose escalation [ Time Frame: 21 days following the first dose of IDE034 ]
Central Contacts
- IDEAYA Clinical Trials1-855-433-2246
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | |
| START New York Long Island, LLC | Lake Success | New York | 11042 | |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | |
| NEXT Texas LLC - Austin | Austin | Texas | 78758 | |
| START Dallas Fort Worth, LLC | Fort Worth | Texas | 76104 | |
| MD Anderson | Houston | Texas | 77030 | |
| NEXT Texas LLC - Houston | Houston | Texas | 77054 | |
| NEXT Texas LLC - Dallas | Irving | Texas | 75039 | |
| NEXT Texas LLC - San Antonio | San Antonio | Texas | 78229 | |
| START San Antonio, LLC | San Antonio | Texas | 78229 | |
| START Mountain Region, LLC | West Valley City | Utah | 84119 | |
| NEXT Texas LLC - Virginia | Fairfax | Virginia | 22031 | |
| Medical Oncology Associates | Spokane | Washington | 99208 |
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