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Experimental cancer drug DS-9606a tested in early trial, but stopped early

NCT ID NCT05394675

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 tested an experimental drug called DS-9606a in 88 people with advanced solid tumors that have a specific protein (Claudin-6). The main goal was to check safety and find the right dose. The trial was terminated, meaning it stopped before completion, so we have limited information on how well it worked.

What this could mean

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

Active substance
DS-9606a (an experimental antibody-drug conjugate given by IV infusion)
What this could lead to
If successful, this could point toward a new treatment option for certain advanced cancers that express Claudin-6.
What could go wrong
This is a very early Phase 1 trial that was terminated, so results are limited. The drug may not be effective or safe enough to continue development.

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

88 people

The number who actually took part.

Started

May 2022

Finished

Feb 2026

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: * At least 18 years old at the time of written informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Availability of archived tumor tissue samples; patients with germ cell tumors without archived tumor samples may be allowed with approval * Has a left ventricular ejection fraction (LVEF) ≥50% as determined by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before the start of study treatment * Adequate bone marrow and organ function within 7 days before the start of study treatment * Life expectancy ≥3 months * Adequate treatment washout period prior to start of study treatment * Male patients with female partners of childbearing potential and female patients of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 6 months (for males) and for at least 7 months (for females) after the last dose of study drug. Males must agree not to freeze or donate sperm throughout the study period for at least 6 months after final administration of study drug. Investigators will advise male patients on the conservation of sperm prior to study treatment. Females must agree not to donate or retrieve ova for own use throughout the study period and for at least 7 months after final study drug administration. * Histologically- or cytologically-documented locally advanced or metastatic cancers, including but not limited to: ovarian cancer (including fallopian tube and primary peritoneal carcinoma), germ cell tumors, uterine and endometrial cancers, pancreatic adenocarcinoma, non-squamous NSCLC, or gastric cancer * Disease progression with standard of care therapies for metastatic disease known to confer benefit, or are intolerant to or refuse standard treatment. Exclusion Criteria: * Has history or current presence of central nervous system metastases, except for participants who have completed radiotherapy or surgery ≥4 weeks before the start of treatment, and fulfill all criteria (no evidence of disease progression in the CNS and no requirement for chronic corticosteroids) within 2 weeks before the start of treatment * Other invasive malignancy within 2 years; prior or concurrent non-invasive malignancies and/or patients with localized malignancies that were treated with curative intent who remain disease-free and are considered low likelihood for recurrence may be enrolled * History of myocardial infarction or unstable angina within 6 months before study treatment * Has a history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment * Has a corrected QT interval by Fridericia's formula (QTcF), of \>470 ms based on the average of triplicate 12-lead electrocardiogram (ECG) per local read * Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Has an uncontrolled infection requiring ongoing or long-term therapy * Has a known active hepatitis or uncontrolled hepatitis B or C infection

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Conditions

The condition(s) this trial relates to.

cancer germ cell tumor metastatic malignant neoplasm neoplasm Neoplasm Metastasis Neoplasms, Germ Cell and Embryonal

As listed by the trial registrant

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

Contacts and locations

Locations

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Florida Cancer Specialists & Research Institute, LLC

    Fort Myers, Florida, 33916, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • SCRI at HealthONE

    Denver, Colorado, 80216, United States

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • The Royal Marsden NHS Trust

    Sutton, SM2 5PT, United Kingdom

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