A Study of IDP-001 in Advanced or Metastatic Solid Tumors
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- InduPro, Inc.
- Study ID
- NCT07602842
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Advanced Solid Tumor
- Cutaneous Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Metastatic Solid Tumor
- Non Squamous Non Small Cell Lung Cancer
- Squamous Cell Carcinoma
- Squamous Cell Carcinoma of the Anus
- Squamous Cell Carcinoma of the Cervix
- Squamous Cell Carcinoma of the Esophagus
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IDP-001 — DRUGIV infusion
Study Details
This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).
Key Dates
- First listed
- May 22, 2026
- Start date
- Jul 8, 2026
- Status verified
- Jul 2026
- Primary completion
- Jun 30, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 132 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Phase 1 Part 1 Dose EscalationParticipants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion.
- Experimental: Phase 1 Part 2 Indication SelectionParticipants with a single tumor indication will receive IDP-001 as IV infusion
Primary Outcome Measure
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1 [ Time Frame: 3 weeks ]
Central Contacts
- InduPro Inc.617-798-1770
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| START Los Angeles | Los Angeles | California | 90025 | Navid Hafez, M.D. (PRINCIPAL_INVESTIGATOR) |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | 941-377-9993 Manish Patel, M.D. (PRINCIPAL_INVESTIGATOR) |
| Community Cancer Center North | Indianapolis | Indiana | 46250 | Nikhil Shukla, M.D. (PRINCIPAL_INVESTIGATOR) |
| Hackensack Meridian - John Theurer Cancer Center | Edison | New Jersey | 08837 | Miguel Gonzalez-Velez, M.D. (PRINCIPAL_INVESTIGATOR) |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | 1-800-767-9355 Prantesh Jain, M.D. (PRINCIPAL_INVESTIGATOR) |
| START New York Long Island | Lake Success | New York | 11042 | Geraldine O'Sullivan-Coyne, M.D. (PRINCIPAL_INVESTIGATOR) |
| START Dallas Forth Worth | Fort Worth | Texas | 76104 | Salwan Al-Mutar, M.D. (PRINCIPAL_INVESTIGATOR) |
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