A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTORL Biotherapeutics, LLC
About this trial
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.
For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).
Eligibility criteria
Qualifiers
Advanced solid tumor
Measurable disease, per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate organ function
Disqualifiers
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-4-500
Progressive or symptomatic brain metastases
Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
Trial design
Treatments tested in this trial
- TORL-4-500
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
TORL Biotherapeutics, LLC
Lead sponsor
Translational Research in Oncology
Collaborator
Source ClinicalTrials.gov