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

Phase 1RecruitingNCT06752681

Day One Biopharmaceuticals, Inc.300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Advanced or Metastatic Solid Tumors

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Site: 001-058

New Haven, Connecticut, United States

RECRUITING

Site: 001-064

Sarasota, Florida, United States

RECRUITING

Site: 001-060

Avon, Indiana, United States

RECRUITING

Site: 001-059

Grand Rapids, Michigan, United States

RECRUITING

Site: 001-039

New York, New York, United States

RECRUITING

Site: 001-073

Oklahoma City, Oklahoma, United States

RECRUITING

Site: 001-065

Nashville, Tennessee, United States

RECRUITING

Site: 001-069

Houston, Texas, United States

RECRUITING

Site: 001-057

San Antonio, Texas, United States

RECRUITING

Site: 011-013

Vancouver, British Columbia, Canada

RECRUITING

...and 1 more locations

Outcomes

Primary Outcomes

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) and 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

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 Outcomes

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

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

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

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

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

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

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

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

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

Phase 1a Dose Escalation: Objective response rate

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

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

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

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

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

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

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (11)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts