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NCT05156866 | RECRUITING | Advanced Solid Tumor

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

TORL Biotherapeutics, LLC

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

Condition or disease

Advanced Solid Tumor

Gastric Cancer

Pancreas Cancer

Gastroesophageal Junction Adenocarcinoma

Intervention/treatment

TORL-2-307-ADC

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer
Actual Study Start Date : 2022-02-02
Estimated Primary Completion Date : 2026-02-15
Estimated Study Completion Date : 2027-02-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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-ADC
  • * 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
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

Location Details

NCT05156866

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Providence St. Jude Medical Center

Fullerton, California, United States, 92835

RECRUITING

United States, California

UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Torrance Memorial Medical

Torrance, California, United States, 90505

RECRUITING

United States, Indiana

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States, 46804

RECRUITING

United States, Missouri

Washington University School of Medicine-Siteman Cancer Center

Saint Louis, Missouri, United States, 63310

RECRUITING

United States, Texas

Texas Oncology-Austin

Austin, Texas, United States, 78705

RECRUITING

United States, Texas

Texas Oncology-Dallas

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

START San Antonio

San Antonio, Texas, United States, 78229

RECRUITING

United States, Texas

Texas Oncology-Tyler

Tyler, Texas, United States, 75702

RECRUITING

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

RECRUITING

Korea, Republic of,

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

Seoul National University Bundang Hospital

Seoul, Korea, Republic of, 13620