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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Day One Biopharmaceuticals, Inc.
Study ID
NCT06752681
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DAY301 — DRUG
    DAY301 will be administered as IV infusion

Study Details

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.

Key Dates

Start date
Nov 18, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
254 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DAY301 intravenous (IV) infusion
    DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts.

Primary Outcome Measure

Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs) [ Time Frame: Within 21 days of first infusion (Day 1) ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Site: 001-058New HavenConnecticut06510-
Site: 001-063Lake MaryFlorida32746-
Site: 001-064SarasotaFlorida34232-
Site: 001-060IndianapolisIndiana46202-
Site: 001-059Grand RapidsMichigan49546-
Site: 001-039New YorkNew York10021-
Site: 001-073Oklahoma CityOklahoma73104-
Site: 001-065NashvilleTennessee37203-
Site: 001-069HoustonTexas77030-
Site: 001-057San AntonioTexas78229-

Find similar trials in New Haven, CT

By research site
Site: 001-058· New Haven, CTSite: 001-063· Lake Mary, FLSite: 001-064· Sarasota, FLSite: 001-060· Indianapolis, INSite: 001-059· Grand Rapids, MISite: 001-039· New York, NY

Related Studies