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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IDP-001 — DRUG
    IV 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 Escalation
    Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion.
  • Experimental: Phase 1 Part 2 Indication Selection
    Participants 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

Locations (7)

FacilityCityStateZIPSite coordinators
START Los AngelesLos AngelesCalifornia90025
Navid Hafez, M.D. (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232
941-377-9993
Manish Patel, M.D. (PRINCIPAL_INVESTIGATOR)
Community Cancer Center NorthIndianapolisIndiana46250
Adam Norris
317-621-3858
Nikhil Shukla, M.D. (PRINCIPAL_INVESTIGATOR)
Hackensack Meridian - John Theurer Cancer CenterEdisonNew Jersey08837
Oncology Clinical Research Referral Office
551-996-1777
Miguel Gonzalez-Velez, M.D. (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14263
1-800-767-9355
Prantesh Jain, M.D. (PRINCIPAL_INVESTIGATOR)
START New York Long IslandLake SuccessNew York11042
Geraldine O'Sullivan-Coyne, M.D. (PRINCIPAL_INVESTIGATOR)
START Dallas Forth WorthFort WorthTexas76104
Salwan Al-Mutar, M.D. (PRINCIPAL_INVESTIGATOR)

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