TrialPath
← Back to searchRecruiting

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

NCT05103683 · TORL Biotherapeutics, LLC
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
About this study
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
Eligibility criteria
Inclusion Criteria: * Advanced solid tumor * Measurable disease, per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function Exclusion Criteria: * Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements * Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23 * Progressive or symptomatic brain metastases * Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection * History of significant cardiac disease * History of myelodysplastic syndrome (MDS) or AML * History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded * If female, is pregnant or breastfeeding
Study design
Enrollment target: 90 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-11-17
Estimated completion: 2026-11-15
Last updated: 2026-02-13
Interventions
Drug: TORL-1-23
Primary outcomes
  • Incidence and severity of adverse events and serious adverse events (up to 2 years)
  • Maximum Tolerated Dose (MTD) (28 Days)
  • Recommended Phase 2 Dose (RP2D) (up to 2 years)
Sponsor
TORL Biotherapeutics, LLC · industry
With: Translational Research in Oncology
Contacts & investigators
ContactNora Ku, MD · contact · nora.ku@torlbio.com · 310-348-9636
ContactIbrahim Qazi · contact · 310-348-9636
InvestigatorNora Ku, MD · study_chair, TORL Biotherapeutics, LLC
All locations (14)
Providence Medical FoundationRecruiting
Fullerton, California, United States
UCLA - JCCC Clinical Research UnitRecruiting
Los Angeles, California, United States
University of Kentucky Medical CenterRecruiting
Lexington, Kentucky, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Mayo Clinic in RochesterRecruiting
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Sarah Cannon Research Institute Texas OncologyRecruiting
Tyler, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
St. Vincent's Hospital, The Catholic University of KoreaRecruiting
Suwon, Gyeonggi-do, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
First in Human Study of TORL-1-23 in Participants With Advanced Cancer · TrialPath