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NCT Number: NCT06752681

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

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 (ADC) 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site: 011-013, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)
  • Cohort 2: Nasopharyngeal primary tumors.
  • 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.

Treatment and study plan

DAY301

Drug

DAY301 will be administered as IV infusion

Primary outcomes

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

    Time frame: 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).

  2. Phase 1a: Dose Escalation: Number of participants with reported adverse events (AEs) and serious AEs (SAEs)

    Time frame: 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.

  3. Phase 1a: Dose Escalation: Frequency of dose interruptions

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

    The frequency at which dose interruptions occur during dose-escalation

  4. Phase 1a: Dose Escalation: Duration of dose interruptions

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

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

  5. Phase 1a: Dose Escalation: Frequency of dose reductions

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

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

  6. Phase 1a: Dose Escalation: Duration of dose reductions

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

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

  7. Phase 1b: Dose Expansion: Objective response rate

    Time frame: through 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).

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

    Time frame: through 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.

  9. Phase 1b: Dose Expansion: Frequency of dose interruptions

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

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

  10. Phase 1b: Dose Expansion: Duration of dose interruption

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

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

  11. Phase 1b: Dose Expansion: Frequency of dose reductions

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

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

  12. Phase 1b: Dose Expansion: Duration of dose reductions

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

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

Secondary outcomes

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

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

    Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters.

  2. 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

    Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters.

  3. 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

    Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters.

  4. 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

    Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters.

  5. Phase 1a Dose Escalation: Objective response rate

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

    Objective response rate based on BOR will be assessed by investigators according to RECIST v1.1.

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

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

    Clinical Benefit rate will be assessed by investigators according to RECIST v1.1.

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

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

    Duration of response will be assessed by investigators according to RECIST v1.1.

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

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

    Time to response will be assessed by investigators according to RECIST v1.1.

  9. Phase 1a and 1b: Progression-free survival

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

    Progression-free survival will be assessed by investigators according to RECIST v1.1.

  10. Phase 1b: Overall survival

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

    Overall survival will be assessed by investigators.

  11. 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

    Assessed by the measure of anti-drug antibodies in serum.

Study contacts

Contact information is provided by the study sponsor or research team.

Day One Clinical Trials Information

CONTACT

[email protected]

650-484-0899

Sponsors and collaborators

Lead sponsor

Day One Biopharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 31, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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