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DAY301 for Advanced or Metastatic Solid Tumors

This study is testing a new treatment called DAY301 for people with advanced or metastatic (spread to other parts of the body) solid tumors. DAY301 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells. The study aims to find out how safe DAY301 is, what side effects it might cause, and how well it works against different cancers like ovarian, breast, lung, and head and neck cancers. Researchers will also look at how your body handles DAY301. This study is currently recruiting about 300 participants.

Study design
This is an open-label, Phase 1a/1b study, meaning both you and your doctors will know you are receiving DAY301. It involves increasing doses to find the safest and most effective amount.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events and dose interruptions through the duration of treatment, up to approximately 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06752681

To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Day One Biopharmaceuticals, Inc.
~300 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:DAY301

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs)
Measured over Within 21 days of first infusion (Day 1)
+11 more outcomes measured

Conditions

Advanced or Metastatic Solid Tumors

Explore related trials

Breast CarcinomaCervical Squamous Cell CarcinomaEndometrial CarcinomaEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaLung Small Cell CarcinomaMalignant Ovarian NeoplasmSolid Neoplasm

Where it's being run

11 sites across 10 states
Texas2
Connecticut1
Florida1
Indiana1
Michigan1
New York1
Oklahoma1
Tennessee1

Who to contact

Day One Clinical Trials Information
[email protected]
650-484-0899
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitors (Phase 1b).
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.

What this trial measures

  • Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs)Within 21 days of first infusion (Day 1)

    To evaluate adverse events (AEs) considered dose limiting toxicities that occur in the first cycle of treatment (within a DLT observation period).

  • Phase 1a: Dose Escalation: Number of participants with reported adverse events (AEs) and serious AEs (SAEs)through the duration of treatment, up to approximately 12 months

    The type, incidence, and severity of AEs and SAEs will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  • Phase 1a: Dose Escalation: Frequency of dose interruptionsthrough the duration of treatment, up to approximately 12 months

    The frequency at which dose interruptions occur during dose-escalation

  • Phase 1a: Dose Escalation: Duration of dose interruptionsthrough the duration of treatment, up to approximately 12 months

    The duration of dose interruptions that occur during dose-escalation.

  • Phase 1a: Dose Escalation: Frequency of dose reductionsthrough the duration of treatment, up to approximately 12 months

    The frequency at which dose reductions occur during dose-escalation.

  • Phase 1a: Dose Escalation: Duration of dose reductionsthrough the duration of treatment, up to approximately 12 months

    The duration of dose reductions that occur during dose-escalation.

  • Phase 1b: Dose Expansion: Objective response ratethrough the duration of treatment, up to approximately 12 months

    Objective response rate based on best overall response (BOR) will be assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

  • Phase 1b: Dose Expansion: Number of participants reporting AEs and SAEsthrough the duration of treatment, up to approximately 12 months

    The type, incidence, and severity of AEs and SAEs will be determined using the NCI CTCAE v5.0.

  • Phase 1b: Dose Expansion: Frequency of dose interruptionsthrough the duration of treatment, up to approximately 12 months

    The frequency at which dose interruptions occur during dose-expansion.

  • Phase 1b: Dose Expansion: Duration of dose interruptionthrough the duration of treatment, up to approximately 12 months

    The duration of dose interruptions that occur during dose-expansion.

  • Phase 1b: Dose Expansion: Frequency of dose reductionsthrough the duration of treatment, up to approximately 12 months

    The frequency at which dose reductions occur during dose-expansion.

  • Phase 1b: Dose Expansion: Duration of dose reductionsthrough the duration of treatment, up to approximately 12 months

    The duration of dose reductions that occur during dose-expansion.