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New drug hope for patients with advanced cancers

NCT ID NCT04145622

Disease control Sponsor: Daiichi Sankyo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called ifinatamab deruxtecan in people with advanced solid tumors that have not been cured by other treatments. The goal is to find the safest dose and see if the drug can shrink tumors. About 250 participants will take part, and those who benefit may continue treatment as long as it works and side effects are manageable.

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 250 people

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

Started

Nov 2019

Expected to finish

Oct 2029

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 score of 0 or 1. * Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator * Has adequate cardiac, hematopoietic, renal and hepatic functions * Has an adequate treatment washout period prior to start of study treatment * Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. For Expansion Cohort 4 2L ESCC participants only: * Has disease progression a post platinum-based and an immune checkpoint inhibitor (ICI) treatment per global or local guidelines, with a maximum of one prior line of systemic therapy for unresectable advanced or metastatic ESCC. Exclusion Criteria: * Has prior treatment with B7-H3 targeted agent, including I-DXd. * Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities. * Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery. * Uncontrolled significant cardiovascular disease * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen * Has an uncontrolled infection requiring systemic therapy. * Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.

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Conditions

The condition(s) this trial relates to.

breast cancer cancer castration-resistant prostate carcinoma endometrial cancer esophageal squamous cell carcinoma head and neck squamous cell carcinoma melanoma neoplasm non-small cell lung carcinoma sarcoma small cell lung carcinoma urinary bladder carcinoma

As listed by the trial registrant

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

Advanced solid tumor Malignant solid tumor

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

    16 sites in 2 countries. 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

  • Aichi Cancer Center Hospital

    RECRUITING

    Aichi, 464-8681, Japan

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Tokyo, 135-8550, Japan

  • Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute

    WITHDRAWN

    Los Angeles, California, 90048, United States

  • Columbia University Medical Center

    WITHDRAWN

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Florida Cancer Specialists

    WITHDRAWN

    Orlando, Florida, 32804, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Henry Ford Hospital

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48202, United States

  • Hokkaido University Hospital

    RECRUITING

    Hokkaido, 060-8648, Japan

  • John Theurer Cancer Center at Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kagawa University Hospital

    RECRUITING

    Kagawa, 761-0793, Japan

  • Keio University Hospital

    RECRUITING

    Tokyo, 160-8582, Japan

  • Kindai University Hospital

    RECRUITING

    Ōsaka-sayama, 589-8511, Japan

  • Kobe City Medical Center General Hospital

    RECRUITING

    Hyōgo, 650-0047, Japan

  • MDACC (MD Anderson Cancer Center)

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan-Kettering Cancer Center

    ACTIVE_NOT_RECRUITING

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Chiba, 277-8577, Japan

  • SCRI Oncology Partners

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37203, United States

  • Saitama Cancer Center

    RECRUITING

    Saitama, 362-0806, Japan

  • Sarah Cannon Research Institute at HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • Shizuoka Cancer Center

    RECRUITING

    Shizuoka, 411-8777, Japan

  • Showa Medical University Hospital

    RECRUITING

    Tokyo, 142-8666, Japan

  • Sidney Kimmel Cancer Center - Thomas Jefferson

    WITHDRAWN

    Philadelphia, Pennsylvania, 19107, United States

  • Tennessee Oncology

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Ohio State University

    WITHDRAWN

    Columbus, Ohio, 43210, United States

  • The University of Osaka Hospital

    RECRUITING

    Osaka, 565-0871, Japan

  • Washington University

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.