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

Description

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.

Conditions

Advanced or Metastatic Solid Tumors

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Study Overview

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Study Details

Study 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 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.

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

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

Condition
Advanced or Metastatic Solid Tumors
Intervention / Treatment

-

Contacts and Locations

San Antonio

Site:001-057, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Day One Biopharmaceuticals, Inc.,

Study Record Dates

2028-12