First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer
Study Details
Study Description
Brief Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Monotherapy Dose Dose Finding - Part 1 TORL-2-307-MAB |
Drug: TORL-2-307-MAB
monoclonal antibody
|
| Experimental: Expansion as Monotherapy - Part 2 TORL-2-307-MAB |
Drug: TORL-2-307-MAB
monoclonal antibody
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse events and serious adverse events [up to 2 years]
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
- Maximum Tolerated Dose (MTD) [28 Days]
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
- Recommended Phase 2 Dose (RP2D) [up to 2 years]
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Secondary Outcome Measures
- Objective Response Rate (ORR) [up to 2 years]
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
- Duration of Response (DOR) [up to 2 years]
Time from CR or PR to objective disease progression or death to any cause
- Progression Free Survival (PFS) [up to 2 years]
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
- Time to Response (TTR) [up to 2 years]
Time from start of treatment to complete response or partial response
- 1 Year Overall Survival (1YOS) [1 year]
Proportion of participants alive at 1 year from the start of treatment to death from any cause
- 2 Year Overall Survival (2YOS) [2 years]
Proportion of participants alive at 2 years from the start of treatment to death from any cause
- Number of anti-drug antibody (ADA) Positive Participants [up to 2 years]
Immunogenicity will be measured by the number of participants that are ADA positive.
- Maximum Serum Concentration of TORL-2-307-MAB (Cmax) [21 days]
PK assessment
- Minimum Serum Concentration of TORL-2-307-MAB (Cmin) [21 days]
PK assessment
- Maximum Serum Concentration of TORL-2-307-MAB at Steady State (Cmax,ss) [63 days]
PK assessment
- Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Cmin,ss) [63 days]
PK assessment
- Time of Maximum Serum Concentration of TORL-2-307-MAB (Tmax) [21 days]
PK assessment
- Time of Minimum Serum Concentration of TORL-2-307-MAB (Tmin) [21 days]
PK Assessment
- Time of Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Tmin,ss) [63 days]
PK Assessment
- Terminal Half-life (t1/2) of Serum TORL-2-307-MAB [63 days]
PK Assessment
- Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23 [21 days]
PK Assessment
- Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23 [63 days]
PK Assessment
- Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-MAB [63 days]
PK Assessment
- Clearance (CL) of TORL-2-307-MAB [63 days]
PK Assessment
- Accumulation ratio (Rac) of TORL-2-307-MAB [63 days]
PK Assessment
Eligibility Criteria
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-2-307-MAB
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA - JCCC Clinical Research Unit | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- TORL Biotherapeutics, LLC
- Translational Research in Oncology
Investigators
- Study Director: Stephen Letrent, PharmD, PhD, TORL Biotherapeutics, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TORL2307MAB-001