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New smart drug takes aim at Hard-to-Treat cancers

NCT ID NCT06752681

Disease control Sponsor: Day One Biopharmaceuticals, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called DAY301 in people with advanced solid tumors that have not responded to standard treatments. The drug is designed to deliver a powerful toxin directly to cancer cells while sparing healthy ones. The study aims to find the safest dose and check if the drug can shrink tumors. About 254 adults with specific cancers like ovarian, lung, or breast cancer will take part.

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 300 people

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

Started

Nov 2024

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: * Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors of the following histologies: * Ovarian cancer * Esophageal squamous cell carcinoma * Triple-negative breast cancer * Non-small cell lung cancer * Small cell lung cancer * Head and neck squamous cell carcinoma * Cervical squamous cell carcinoma * Endometrial cancers (Participants must have been previously treated with standard of care systemic therapy, have refused standard therapy, or have no standard therapy available). * Availability of tumor tissue sample (either an archival specimen or a fresh biopsy) at screening * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitors (Phase 1b). * Phase 1b disease-specific exclusion criteria: 1. Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas) 2. Cohort 2: Nasopharyngeal primary tumors. 3. Cohort 3: Ovarian cancer that progressed \>6 months after the last dose of platinum-based chemotherapy (platinum-sensitive disease), or disease that did not respond (PR or complete response \[CR\]) to or progressed ≤91 days after the last dose of first-line platinum-based chemotherapy (primary platinum-refractory disease) .- History of small bowel obstruction requiring hospitalization within 3 months prior to the first dose of study treatment. * Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management, or new onset within 4 weeks prior to the first dose of study treatment. Patients with an indwelling catheter may be considered eligible, after consultation with the medical monitor. * Active or progressing brain metastases or evidence of leptomeningeal disease. * Persistent toxicities from previous systemic antineoplastic treatments of Grade \>1, excluding alopecia and vitiligo. * Systemic antineoplastic therapy within five half-lives or 4 weeks, whichever is shorter, prior to first dose of study treatment, including investigational agents. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

cervical squamous cell carcinoma endometrial cancer esophageal squamous cell carcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma metastatic malignant neoplasm non-small cell lung carcinoma ovarian cancer small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Advanced or metastatic solid tumors

How to take part

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

  1. The places running it

    11 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Site: 001-039

    RECRUITING

    New York, New York, 10065, United States

  • Site: 001-057

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Site: 001-058

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Site: 001-059

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Site: 001-060

    RECRUITING

    Avon, Indiana, 46202, United States

  • Site: 001-064

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Site: 001-065

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Site: 001-069

    RECRUITING

    Houston, Texas, 77030, United States

  • Site: 001-073

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Site: 011-005

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Site: 011-013

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

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