Clinical trial NCT06752681: To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Keywords: Advanced or metastatic solid tumors
Dose Escalation
Dose Expansion
DAY301
PTK7-Targeted Antibody-drug Conjugate
Lead sponsor: Day One Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 patients with advanced or metastatic solid tumors. The study comprises of 2 phases: Phase 1a dose escalation where patients 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.


Eligibility criteria: Inclusion Criteria:

* Patients with 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

(Patients 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 (RECIST v1.1).
* ECOG performance status of 0 or 1.
* Adequate organ function.

Exclusion Criteria:

* Prior use of PTK7 targeting treatment.
* 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 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study drug, including investigational agents.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs)
timeFrame: Within 21 days of first infusion (Day 1)
measure: Phase 1a: Dose Escalation: Number of participants with reported adverse events (AEs) or serious AEs (SAEs)
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a: Dose Escalation: Frequency of dose interruptions
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a: Dose Escalation: Duration of dose interruptions
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a: Dose Escalation: Frequency of dose reductions
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a: Dose Escalation: Duration of dose reductions
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1b: Dose Expansion: Overall response rate
timeFrame: through the duration of treatment, up to approximately 12 months-up
measure: Phase 1b: Dose Expansion: Number of participants reporting AEs and SAEs
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1b: Dose Expansion: Frequency of dose interruptions
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1b: Dose Expansion: Duration of dose interruption
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1b: Dose Expansion: Frequency of dose reductions
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1b: Dose Expansion: Duration of dose reductions
timeFrame: through the duration of treatment, up to approximately 12 months
Secondary outcomes:
measure: Phase 1a and Phase 1b: Maximum concentration (Cmax) of DAY301
timeFrame: Varying timepoints through the duration of treatment, up to approximately 12 months
measure: Phase 1a and Phase 1b: time to Cmax (Tmax) of DAY301
timeFrame: Varying timepoints through the duration of treatment, up to approximately 12 months
measure: Phase 1a and Phase 1b: area under the curve (AUC) of DAY301
timeFrame: Varying timepoints through the duration of treatment, up to approximately 12 months
measure: Phase 1a and Phase 1b: terminal half-life (t1/2) of DAY301
timeFrame: Varying timepoints through the duration of treatment, up to approximately 12 months
measure: Phase 1a Dose Escalation: Overall response rate
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a and 1b: Clinical Benefit rate (CBR)
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a and 1b: duration of response (DOR)
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a and 1b: time to response (TTR)
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a and 1b: Progression-free survival
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a and 1b: Overall survival
timeFrame: through the duration of treatment, up to approximately 12 months
measure: Phase 1a and 1b: Number of participants with positive antidrug antibodies (ADAs)
timeFrame: varying timepoints through the duration of treatment, up to approximately 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Site: 001-060
state: Indiana
city: Grand Rapids
country: United States
facility: Site: 001-059
state: Michigan
city: San Antonio
country: United States
facility: Site: 001-057
state: Texas
Study officials:
References: