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New drug IDE034 targets Hard-to-Treat cancers in early trial

NCT ID NCT07503808

Disease control Sponsor: IDEAYA Biosciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study is testing an experimental drug called IDE034 in 150 adults with advanced solid tumors (such as lung, ovarian, or colorectal cancer) that have not responded to standard treatments. The main goals are to check the drug's safety, find the right dose, and see if it can shrink tumors. Participants must have tumors that show certain markers (B7-H3 and PTK7).

Why investors are watching

Ideaya Biosciences is running a Phase 1 trial of IDE034, a drug for patients with advanced solid tumors that show two specific markers, B7-H3 and PTK7. For a small company, this early-stage readout matters because it is the first test of whether the drug is safe and shows any sign of shrinking tumors, which could validate its pipeline. The result is consequential because a small company's value often hinges on a single experimental drug's progress.

If it works: If the trial shows IDE034 is safe and controls tumor growth, Ideaya could advance the drug to later-stage studies and attract partnership interest. A positive signal would strengthen the company's position as a developer of targeted cancer therapies.

If it fails: Phase 1 trials fail often, and IDE034 could prove unsafe or ineffective, which would likely end the program and hurt the company's prospects. Delays in enrollment or safety issues could also stall progress and raise doubts about the drug's future.

AI-written from the trial record. Speculative, and not investment advice.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 150 people

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

Started

Feb 2026

Expected to finish

Jul 2027

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: 1. Participant must be at least 18 years of age or the age of maturity per local regulations 2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \[HER2\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies. 3. Archival tissue sample for testing 4. Measurable disease 5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Have adequate bone marrow and organ function. 7. Able to comply with contraceptive/barrier requirements Exclusion Criteria: 1. Known symptomatic brain metastases or leptomeningeal metastasis 2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose. 3. Have uncontrolled tumor-associated pain 4. Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose 5. Active uncontrolled infection 6. Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose. 7. Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization. 8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening. 9. Participants with known or suspected viral hepatitis 10. Have history of active tuberculosis within 1 year before enrollment 11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms 12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP 13. Administration of any of the following 1. Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers 2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC). 3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP 4. Have received radiotherapy within 2 weeks prior to study entry 5. Have undergone major surgery or trauma within 4 weeks prior to study entry. 6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment. 7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP. 8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody/fusion protein drugs. 9. Participants with complications in the eye including ulcers in the eye, and severe dry eye

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm esophageal squamous cell carcinoma head and neck squamous cell carcinoma non-small cell lung carcinoma ovarian serous adenocarcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

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

Castration-resistant prostate cancer Colorectal cancer Endometrium cancer Esophageal squamous cell carcinoma Head and neck squamous cell carcinoma High grade serous ovarian cancer Non-small cell lung cancer Triple-negative breast cancer

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

    15 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

Locations

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

  • Medical Oncology Associates

    RECRUITING

    Spokane, Washington, 99208, United States

  • NEXT Texas LLC - Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Texas LLC - Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Texas LLC - Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT Texas LLC - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Texas LLC - Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

    Contact Email: •••••@•••••

  • START Dallas Fort Worth, LLC

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • START Mountain Region, LLC

    RECRUITING

    West Valley City, Utah, 84119, United States

    Contact Email: •••••@•••••

  • START New York Long Island, LLC

    RECRUITING

    Lake Success, New York, 11042, United States

    Contact Email: •••••@•••••

  • START San Antonio, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • Sarah Cannon Research Institute at HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

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