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First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

Primary Purpose

Advanced Solid Tumor, Gastric Cancer, Pancreas Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TORL-2-307-ADC
Sponsored by
TORL Biotherapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor focused on measuring claudin18.2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA - JCCC Clinical Research UnitRecruiting
  • Torrance Memorial MedicalRecruiting
  • Fort Wayne Medical Oncology and HematologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Monotherapy Dose Dose Finding - Part 1

Expansion as Monotherapy - Part 2

Arm Description

TORL-2-307-ADC

TORL-2-307-ADC

Outcomes

Primary Outcome Measures

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
Maximum Tolerated Dose (MTD)
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Recommended Phase 2 Dose (RP2D)
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Secondary Outcome Measures

Objective Response Rate (ORR)
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Duration of Response (DOR)
Time from CR or PR to objective disease progression or death to any cause
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 to Response (TTR)
Time from start of treatment to complete response or partial response
1 Year Overall Survival (1YOS)
Proportion of participants alive at 1 year from the start of treatment to death from any cause
2 Year Overall Survival (2YOS)
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
Immunogenicity will be measured by the number of participants that are ADA positive.
Maximum Serum Concentration of TORL-2-307-ADC (Cmax)
PK assessment
Minimum Serum Concentration of TORL-2-307-ADC (Cmin)
PK assessment
Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss)
PK assessment
Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss)
PK assessment
Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax)
PK assessment
Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin)
PK Assessment
Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss)
PK Assessment
Terminal Half-life (t1/2) of Serum TORL-2-307-ADC
PK Assessment
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23
PK Assessment
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23
PK Assessment
Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC
PK Assessment
Clearance (CL) of TORL-2-307-ADC
PK Assessment
Accumulation ratio (Rac) of TORL-2-307-ADC
PK Assessment

Full Information

First Posted
December 1, 2021
Last Updated
March 2, 2023
Sponsor
TORL Biotherapeutics, LLC
Collaborators
Translational Research in Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT05156866
Brief Title
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer
Official Title
A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
January 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TORL Biotherapeutics, LLC
Collaborators
Translational Research in Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Gastric Cancer, Pancreas Cancer, Gastroesophageal Junction Adenocarcinoma
Keywords
claudin18.2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy Dose Dose Finding - Part 1
Arm Type
Experimental
Arm Description
TORL-2-307-ADC
Arm Title
Expansion as Monotherapy - Part 2
Arm Type
Experimental
Arm Description
TORL-2-307-ADC
Intervention Type
Drug
Intervention Name(s)
TORL-2-307-ADC
Intervention Description
antibody drug conjugate
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events and serious adverse events
Description
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
Time Frame
up to 2 years
Title
Maximum Tolerated Dose (MTD)
Description
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Time Frame
28 Days
Title
Recommended Phase 2 Dose (RP2D)
Description
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Time Frame
up to 2 years
Title
Duration of Response (DOR)
Description
Time from CR or PR to objective disease progression or death to any cause
Time Frame
up to 2 years
Title
Progression Free Survival (PFS)
Description
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 years
Title
Time to Response (TTR)
Description
Time from start of treatment to complete response or partial response
Time Frame
up to 2 years
Title
1 Year Overall Survival (1YOS)
Description
Proportion of participants alive at 1 year from the start of treatment to death from any cause
Time Frame
1 year
Title
2 Year Overall Survival (2YOS)
Description
Proportion of participants alive at 2 years from the start of treatment to death from any cause
Time Frame
2 years
Title
Number of anti-drug antibody (ADA) Positive Participants
Description
Immunogenicity will be measured by the number of participants that are ADA positive.
Time Frame
up to 2 years
Title
Maximum Serum Concentration of TORL-2-307-ADC (Cmax)
Description
PK assessment
Time Frame
21 days
Title
Minimum Serum Concentration of TORL-2-307-ADC (Cmin)
Description
PK assessment
Time Frame
21 days
Title
Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss)
Description
PK assessment
Time Frame
63 days
Title
Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss)
Description
PK assessment
Time Frame
63 days
Title
Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax)
Description
PK assessment
Time Frame
21 days
Title
Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin)
Description
PK Assessment
Time Frame
21 days
Title
Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss)
Description
PK Assessment
Time Frame
63 days
Title
Terminal Half-life (t1/2) of Serum TORL-2-307-ADC
Description
PK Assessment
Time Frame
63 days
Title
Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-1-23
Description
PK Assessment
Time Frame
21 days
Title
Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-1-23
Description
PK Assessment
Time Frame
63 days
Title
Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC
Description
PK Assessment
Time Frame
63 days
Title
Clearance (CL) of TORL-2-307-ADC
Description
PK Assessment
Time Frame
63 days
Title
Accumulation ratio (Rac) of TORL-2-307-ADC
Description
PK Assessment
Time Frame
63 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Letrent, PharmD, PhD
Phone
858-342-6652
Email
stephen.letrent@torlbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Letrent, PharmD, PhD
Organizational Affiliation
TORL Biotherapeutics, LLC
Official's Role
Study Director
Facility Information:
Facility Name
UCLA - JCCC Clinical Research Unit
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zev Wainberg, MD
Phone
310-586-2094
Facility Name
Torrance Memorial Medical
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Hool, MD
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Babu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

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