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

This study is testing a new medicine called IDP-001, given as an IV infusion, for people with advanced or metastatic (spread to other parts of the body) solid tumors. This includes specific types like head and neck, cutaneous (skin), and cervical squamous cell carcinoma. The main goals are to see how safe IDP-001 is, how well your body handles it, and if it can shrink tumors. You might be able to join if you have certain advanced solid tumors that haven't responded to other treatments, are at least 18 years old, and have a good general health status. The study plans to enroll about 132 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive IDP-001. It plans to enroll about 132 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for approximately 6 months, and tumor response will also be assessed for approximately 6 months.

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NCT07602842

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
InduPro, Inc.
~132 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:IDP-001

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1
Measured over 3 weeks
+3 more outcomes measured

Conditions

Advanced Solid Tumor
Metastatic Solid Tumor
Head and Neck Squamous Cell Carcinoma
Cutaneous Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Cervix
Non Squamous Non Small Cell Lung Cancer
Squamous Cell Carcinoma of the Esophagus
Squamous Cell Carcinoma of the Anus
Squamous Cell Carcinoma

Explore related trials

Anal Squamous Cell CarcinomaCervical Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaLung Non-Small Cell Squamous CarcinomaSkin Squamous Cell CarcinomaSolid NeoplasmSquamous Cell Carcinoma

Where it's being run

7 sites across 6 states
New York2
California1
Florida1
Indiana1
New Jersey1
Texas1

Who to contact

InduPro Inc.
[email protected]
617-798-1770
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 13 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 DiscontinuationApproximately 6 months
  • Phase 1 Part 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by InvestigatorApproximately 6 months
  • Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by InvestigatorApproximately 6 months