Recruiting
Phase 1
Phase 2

IDP-001

Sponsor:

InduPro, Inc.

Code:

NCT07602842

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Head and Neck Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma

Squamous Cell Carcinoma of the Cervix

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IDP-001

Study Details

Brief summary:

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).

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Head and Neck Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma

Squamous Cell Carcinoma of the Cervix

Study ID

NCT07602842

Start date

Jul 8, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
  • Satisfy requirements for prior treatments per tumor type as outlined in the protocol
  • Measurable disease per RECIST v1.1
  • Participant willing to provide tumor biopsies
  • Adequate organ function
  • Agree to contraception requirements as outlined in the protocol
  • Life expectancy greater than 12 weeks

Exclusion Criteria:

  • Any clinically significant cardiac disease
  • Any clinically significant corneal disorder
  • Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.
  • Active significant neurologic disorders
  • Requires home oxygen
  • Active autoimmune disease
  • History or active skin disease requiring frequent treatment
  • History of major immunologic reaction to prior immunoglobulin G-containing agent
  • Clinically significant ascites or liver disease
  • Uncontrolled diabetes or diabetic neuropathy
  • Active bleeding disorders
  • Participation in a concurrent clinical study in the treatment period
  • Pregnant or lactating or planning to become pregnant
  • Known hypersensitivity to IDP-001 or any of its ingredients
  • Unresolved toxicities from previous anticancer therapy
  • Has had a seizure prior to Screening
  • Prior solid organ transplant or allogeneic stem cell transplant
  • Current endocrinopathy
  • History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis
  • History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids
  • Stroke or transient ischemic attack prior to Screening
  • Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

IDP-001

IV infusion

Primary outcome measure

  • Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1 [ Time Frame: 3 weeks ]
  • Phase 1 Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation [ Time Frame: Approximately 6 months ]
  • Phase 1 Part 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator [ Time Frame: Approximately 6 months ]
  • Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator [ Time Frame: Approximately 6 months ]

Central Contacts and Locations

Central contacts

InduPro Inc.

617-798-1770clinicaltrials@induprotx.com

Locations

START Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

hopeteam@startresearch.com

Principal Investigator:

Navid Hafez, M.D.

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Contacts

941-377-9993clinicaltrials@flcancer.com

Principal Investigator:

Manish Patel, M.D.

Community Cancer Center North

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Adam Norris

317-621-3858anorris@ecommunity.com

Principal Investigator:

Nikhil Shukla, M.D.

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

1-800-767-9355AskRoswell@RoswellPark.org

Principal Investigator:

Prantesh Jain, M.D.

START New York Long Island

Recruiting

Lake Success, New York, United States, 11042

Contacts

hopeteam@startresearch.com

Principal Investigator:

Geraldine O'Sullivan-Coyne, M.D.

START Dallas Forth Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

hopeteam@startresearch.com

Principal Investigator:

Salwan Al-Mutar, M.D.

More Information

Sponsor

InduPro, Inc.

Last update posted

Sep 3, 2026

Last verified

Jul, 2026

Keywords

  • NSCLC
  • Squamous NSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by InduPro, Inc. on 2026-09-03.