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RecruitingInterventionalPhase 1

A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of the PTK7-Targeted Antibody-drug Conjugate DAY301 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT ID: NCT06752681Sponsor: Day One Biopharmaceuticals, Inc.Last updated: 2025-10-10

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.

Arms & interventions

  • DrugDAY301

    DAY301 will be administered as IV infusion

Outcome measures

Primary

  • 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).

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: through the duration of treatment, up to approximately 12 months

Secondary

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

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

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

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

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

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

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

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

  • Phase 1a Dose Escalation: Objective response rate

    Time frame: through the duration of treatment, up to approximately 12 months

  • Phase 1a and 1b: Clinical Benefit rate (CBR)

    Time frame: through the duration of treatment, up to approximately 12 months

  • Phase 1a and 1b: duration of response (DOR)

    Time frame: through the duration of treatment, up to approximately 12 months

  • Phase 1a and 1b: time to response (TTR)

    Time frame: through the duration of treatment, up to approximately 12 months

  • Phase 1a and 1b: Progression-free survival

    Time frame: through the duration of treatment, up to approximately 12 months

  • Phase 1b: Overall survival

    Time frame: through the duration of treatment, up to approximately 12 months

  • Phase 1a and 1b: Number of participants with positive antidrug antibodies (ADAs)

    Time frame: varying timepoints through the duration of treatment, up to approximately 12 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 * 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. Exclusion Criteria: * 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). * 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: 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) 3. 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study locations (10)

Site: 001-058

New Haven, Connecticut, 06510

Recruiting

Site: 001-063

Lake Mary, Florida, 32746

Recruiting

Site: 001-064

Sarasota, Florida, 34232

Recruiting

Site: 001-060

Indianapolis, Indiana, 46202

Recruiting

Site: 001-059

Grand Rapids, Michigan, 49546

Recruiting

Site: 001-039

New York, New York, 10021

Recruiting

Site: 001-073

Oklahoma City, Oklahoma, 73104

Recruiting

Site: 001-065

Nashville, Tennessee, 37203

Recruiting

Site: 001-069

Houston, Texas, 77030

Recruiting

Site: 001-057

San Antonio, Texas, 78229

Recruiting