First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Part of paid clinical trials in Fullerton, California.

Sponsor
TORL Biotherapeutics, LLC
Study ID
NCT05103683
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • TORL-1-23 — DRUG
    antibody drug conjugate (ADC)

Study Details

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

Key Dates

Start date
Nov 17, 2021
Status verified
Jul 2025
Primary completion
Aug 31, 2026
Completion
Nov 15, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Dose Finding - Part 1
    TORL-1-23
  • Experimental: Expansion as Monotherapy - Part 2
    TORL-1-23

Primary Outcome Measure

Incidence and severity of adverse events and serious adverse events [ Time Frame: up to 2 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Providence Medical FoundationFullertonCalifornia92835
Yung Lyou, MD
UCLA - JCCC Clinical Research UnitLos AngelesCalifornia90095
Gottfried Konecny, MD
310-794-4955
Gottfired Konecny, MD (PRINCIPAL_INVESTIGATOR)
University of Kentucky Medical CenterLexingtonKentucky40536
John Villano, MD
University of MinnesotaMinneapolisMinnesota55455
Boris Winterhoff, MD, PhD
612-624-8003
Boris Winterhoff, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Andrea Wahner Hendrickson, MD
855-776-0015
Andrea Wahner Hendrickson, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Emily Slotkin, MD
Cleveland ClinicClevelandOhio44195
Alex Adjei, MD
Sarah Cannon Research Institute Texas OncologyTylerTexas75702
Heather Pulaski, MD
Heather Pulaski, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Alexander Spira, MD

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By research site
Providence Medical Foundation· Fullerton, CAUCLA - JCCC Clinical Research Unit· Los Angeles, CAUniversity of Kentucky Medical Center· Lexington, KYUniversity of Minnesota· Minneapolis, MNMayo Clinic in Rochester· Rochester, MNMemorial Sloan Kettering Cancer Center· New York, NY

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