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New drug IDP-001 takes on advanced cancers in early trial

NCT ID NCT07602842

Disease control Sponsor: InduPro, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 9 times

Summary

This study tests an experimental drug called IDP-001 in people with advanced or metastatic solid tumors, including certain lung, head and neck, and other cancers. The trial has two phases: first to check safety and find the right dose, then to see if the drug can shrink tumors. About 132 participants will receive IDP-001 by IV infusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IDP-001 (an experimental drug given by IV infusion)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early phase 1/2 trial with only 132 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anal squamous cell carcinoma anus neoplasm cervical squamous cell carcinoma esophageal squamous cell carcinoma head and neck squamous cell carcinoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis non-small cell lung carcinoma skin squamous cell carcinoma squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck squamous cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Community Cancer Center North

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

    Contact Email: •••••@•••••

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • START Dallas Forth Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • START Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

    Contact Email: •••••@•••••

  • START New York Long Island

    RECRUITING

    Lake Success, New York, 11042, United States

    Contact Email: •••••@•••••

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