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NCT Number: NCT07602842

A Study of IDP-001 in Advanced or Metastatic Solid Tumors

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IDP-001

Drug

IV infusion

Primary outcomes

  1. Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1

    Time frame: 3 weeks

  2. 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

  3. 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

  4. Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator

    Time frame: Approximately 6 months

Secondary outcomes

  1. Area Under the Concentration Time Curve (AUC) of IDP-001

    Time frame: Approximately 6 months

  2. Maximum Observed Plasma Concentration (Cmax) of IDP-001

    Time frame: Approximately 6 months

  3. Number of Participants with Anti-drug Antibodies (ADAs) in Blood

    Time frame: Approximately 6 months

  4. Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator

    Time frame: Approximately 6 months

  5. Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator

    Time frame: Approximately 6 months

  6. Phase 1 Part 2: 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

  7. Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator

    Time frame: Approximately 6 months

  8. Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator

    Time frame: Approximately 6 months

  9. Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator

    Time frame: Approximately 6 months

  10. Phase 1 Part 2: Overall Survival (OS)

    Time frame: Approximately 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

InduPro Inc.

CONTACT

[email protected]

617-798-1770

Sponsors and collaborators

Lead sponsor

InduPro, Inc.

Industry

Registry information

Official study title

A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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