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

RecruitingPhase 1

A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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

What is being tested

Sponsor: TORL Biotherapeutics, LLC · Participants: 90 · Started: Nov 17, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT05103683

Locations in the U.S.

CaliforniaProvidence Medical Foundation, Fullerton
UCLA - JCCC Clinical Research Unit, Los Angeles
KentuckyUniversity of Kentucky Medical Center, Lexington
MinnesotaUniversity of Minnesota, Minneapolis
Mayo Clinic in Rochester, Rochester
New YorkMemorial Sloan Kettering Cancer Center, New York
OhioCleveland Clinic, Cleveland
TexasSarah Cannon Research Institute Texas Oncology, Tyler
VirginiaVirginia Cancer Specialists, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.