Colorectal Cancer Clinical Trial
Official title:
A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer
Status | Recruiting |
Enrollment | 70 |
Est. completion date | September 15, 2026 |
Est. primary completion date | September 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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-3-600 - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre | Montréal | Quebec |
Canada | University Health Network, Princess Margaret Cancer Centre | Toronto | Ontario |
United States | Mary Crowley Cancer Research | Dallas | Texas |
United States | UCLA - JCCC Clinical Research Unit | Los Angeles | California |
United States | Washington University School of Medicine-Siteman Cancer Center | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
TORL Biotherapeutics, LLC | Translational Research in Oncology |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | up to 2 years | |
Primary | Maximum Tolerated Dose (MTD) | Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants | 28 Days | |
Primary | Recommended Phase 2 Dose (RP2D) | Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data | up to 2 years | |
Secondary | Objective Response Rate (ORR) | Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1 | up to 2 years | |
Secondary | Duration of Response (DOR) | Time from CR or PR to objective disease progression or death to any cause | up to 2 years | |
Secondary | 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 | up to 2 years | |
Secondary | Time to Response (TTR) | Time from start of treatment to complete response or partial response | up to 2 years | |
Secondary | 1 Year Overall Survival (1YOS) | Proportion of participants alive at 1 year from the start of treatment to death from any cause | 1 year | |
Secondary | 2 Year Overall Survival (2YOS) | Proportion of participants alive at 2 years from the start of treatment to death from any cause | 2 years | |
Secondary | Number of anti-drug antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive. | up to 2 years | |
Secondary | Maximum Serum Concentration of TORL-3-600 (Cmax) | PK assessment | 21 days | |
Secondary | Minimum Serum Concentration of TORL-3-600 (Cmin) | PK assessment | 21 days | |
Secondary | Maximum Serum Concentration of TORL-3-600 at Steady State (Cmax,ss) | PK assessment | 63 days | |
Secondary | Minimum Serum Concentration of TORL-3-600 at Steady State (Cmin,ss) | PK assessment | 63 days | |
Secondary | Time of Maximum Serum Concentration of TORL-3-600 (Tmax) | PK assessment | 21 days | |
Secondary | Time of Minimum Serum Concentration of TORL-3-600 (Tmin) | PK Assessment | 21 days | |
Secondary | Time of Minimum Serum Concentration of TORL-3-600 at Steady State (Tmin,ss) | PK Assessment | 63 days | |
Secondary | Terminal Half-life (t1/2) of Serum TORL-3-600-ADC | PK Assessment | 63 days | |
Secondary | Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23 | PK Assessment | 21 days | |
Secondary | Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23 | PK Assessment | 63 days | |
Secondary | Apparent volume of distribution during the terminal phase (Vz) of TORL-3-600 | PK Assessment | 63 days | |
Secondary | Clearance (CL) of TORL-3-600 | PK Assessment | 63 days | |
Secondary | Accumulation ratio (Rac) of TORL-3-600 | PK Assessment | 63 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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