First in Human Study of TORL-1-23 in Participants 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-1-23 in patients with advanced cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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-1-23
Progressive or symptomatic brain metastases
Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
Trial design
Design model
Sequential
Treatments tested in this trial
TORL-1-23
Drugantibody drug conjugate (ADC)
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Monotherapy Dose Finding - Part 1Experimental treatment 1 intervention
Group B: Expansion as Monotherapy - Part 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events and serious adverse events
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Time frame
up to 2 years2
Maximum Tolerated Dose (MTD)
Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Time frame
28 Days3
Recommended Phase 2 Dose (RP2D)
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Time frame
up to 2 yearsSecondary outcomes
1
Objective Response Rate (ORR)
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Time frame
up to 2 years2
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
Time frame
up to 2 years3
Progression Free Survival (PFS)
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
Time frame
up to 2 years4
Time to Response (TTR)
Time from start of treatment to complete response or partial response
Time frame
up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
TORL Biotherapeutics, LLC
Lead sponsor
Translational Research in Oncology
Collaborator
Source ClinicalTrials.gov