RecruitingPhase 1NCT05103683
First in Human Study of TORL-1-23 in Participants With Advanced Cancer
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer
Sponsor
TORL Biotherapeutics, LLC
Enrollment
90 participants
Start Date
Nov 17, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
Exclusion Criteria8
- 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
Interventions
DRUGTORL-1-23
antibody drug conjugate (ADC)
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05103683
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