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

NCT06752681 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DAY301-001
• Study Type: interventional
• Target: 254
• Locations: 2 countries
• Sites: 12

Brief Summary

This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, a PTK7-directed antibody-drug conjugate in participants with advanced or metastatic solid tumors. The study comprises of 2 phases: Phase 1a dose escalation where participants will be administered DAY301 at escalating dose levels to assess safety and tolerability, and to determine the maximum tolerated dose (MTD) and/or the recommended dose (RD); In Phase 1b dose expansion, DAY301 will be evaluated in dose expansion cohorts.

Conditions

Advanced or Metastatic Solid Tumors

Keywords

Advanced or metastatic solid tumors; Dose Escalation; Dose Expansion; DAY301; PTK7-Targeted Antibody-drug Conjugate

Outcome Measures

Primary Outcomes (12)

• Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs)

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

  Within 21 days of first infusion (Day 1)

• Phase 1a: Dose Escalation: Number of participants with reported adverse events (AEs) or serious AEs (SAEs)

  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.

  through the duration of treatment, up to approximately 12 months

• Phase 1a: Dose Escalation: Frequency of dose interruptions

  The frequency at which dose interruptions occur during dose-escalation

  through the duration of treatment, up to approximately 12 months

• Phase 1a: Dose Escalation: Duration of dose interruptions

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

  through the duration of treatment, up to approximately 12 months

• Phase 1a: Dose Escalation: Frequency of dose reductions

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

  through the duration of treatment, up to approximately 12 months

• Phase 1a: Dose Escalation: Duration of dose reductions

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

  through the duration of treatment, up to approximately 12 months

• Phase 1b: Dose Expansion: Objective response rate

  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).

  through the duration of treatment, up to approximately 12 months-up

• Phase 1b: Dose Expansion: Number of participants reporting AEs and SAEs

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

  through the duration of treatment, up to approximately 12 months

• Phase 1b: Dose Expansion: Frequency of dose interruptions

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

  through the duration of treatment, up to approximately 12 months

• Phase 1b: Dose Expansion: Duration of dose interruption

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

  through the duration of treatment, up to approximately 12 months

• Phase 1b: Dose Expansion: Frequency of dose reductions

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

  through the duration of treatment, up to approximately 12 months

• Phase 1b: Dose Expansion: Duration of dose reductions

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

  through the duration of treatment, up to approximately 12 months

Secondary Outcomes (11)

• Phase 1a and Phase 1b: Maximum concentration (Cmax) of DAY301

  Varying timepoints through the duration of treatment, up to approximately 12 months

• Phase 1a and Phase 1b: time to Cmax (Tmax) of DAY301

  Varying timepoints through the duration of treatment, up to approximately 12 months

• Phase 1a and Phase 1b: area under the curve (AUC) of DAY301

  Varying timepoints through the duration of treatment, up to approximately 12 months

• Phase 1a and Phase 1b: terminal half-life (t1/2) of DAY301

  Varying timepoints through the duration of treatment, up to approximately 12 months

• Phase 1a Dose Escalation: Objective response rate

  through the duration of treatment, up to approximately 12 months

Study Arms (1)

DAY301 intravenous (IV) infusion

EXPERIMENTAL

DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts.

Drug: DAY301

Interventions

DAY301 DRUG

DAY301 will be administered as IV infusion

DAY301 intravenous (IV) infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Gastric/gastroesophageal junction adenocarcinoma
• Cervical squamous cell carcinoma
• Endometrial cancers
• (Participants must have been previously treated with standard of care systemic therapy, or for whom no standard therapy is 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.

You may not qualify if:

• Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitor-based antibody-drug conjugate (ADC) (Phase 1b).
• Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)
• Cohort 2: Ovarian cancer that progressed \>6 months after the last dose of platinum-based chemotherapy (platinum-sensitive disease), or disease that did not respond (partial response \[PR\] or complete response \[CR\]) to or progressed ≤91 days after the last dose of first-line platinum-based chemotherapy (primary platinum-refractory disease)
• Cohort 3: nasopharyngeal primary tumors.
• 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.

Sponsors & Collaborators

• Day One Biopharmaceuticals, Inc.: lead

Study Sites (12)

Site: 001-058

New Haven, Connecticut, 06510, United States

RECRUITING

Site: 001-063

Lake Mary, Florida, 32746, United States

RECRUITING

Site: 001-064

Sarasota, Florida, 34232, United States

RECRUITING

Site: 001-060

Indianapolis, Indiana, 46202, United States

RECRUITING

Site: 001-059

Grand Rapids, Michigan, 49546, United States

RECRUITING

Site: 001-039

New York, New York, 10021, United States

RECRUITING

Site: 001-073

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Site: 001-065

Nashville, Tennessee, 37203, United States

RECRUITING

Site: 001-069

Houston, Texas, 77030, United States

RECRUITING

Site: 001-057

San Antonio, Texas, 78229, United States

RECRUITING

Site: 011-013

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Site: 011-005

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Central Study Contacts

Day One Clinical Trials Information

CONTACT

650-484-0899; clinicaltrials@dayonebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

CA (2); US (10)