Testing a new cancer treatment in patients with advanced tumors
A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer
This study is testing a new cancer treatment to see if it helps people with advanced tumors, like gastric and pancreatic cancers, feel better and manage their disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TORL Biotherapeutics, LLC Industry-sponsored |
| Locations | 12 sites (Fullerton, California and 11 other locations) |
| Trial ID | NCT05156866 on ClinicalTrials.gov |
What this trial studies
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced solid tumors, including gastric and pancreatic cancers. Participants will receive the investigational drug to assess its effects on their cancer. The study aims to determine how well the treatment works and its potential side effects in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced solid tumors who have measurable disease and meet specific health criteria.
Not a fit: Patients with recent cancer treatments, significant cardiac issues, or certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that currently have limited treatment options.
How similar studies have performed: While this is a first-in-human study, similar approaches targeting claudin18.2 have shown promise in early research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fullerton, California and 11 other locations
- Providence St. Jude Medical Center — Fullerton, California, United States (Recruiting)
- UCLA - JCCC Clinical Research Unit — Los Angeles, California, United States (Recruiting)
- Torrance Memorial Medical — Torrance, California, United States (Recruiting)
- Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (Recruiting)
- Washington University School of Medicine-Siteman Cancer Center — Saint Louis, Missouri, United States (Recruiting)
- Texas Oncology-Austin — Austin, Texas, United States (Recruiting)
- Texas Oncology-Dallas — Dallas, Texas, United States (Recruiting)
- START San Antonio — San Antonio, Texas, United States (Recruiting)
- Texas Oncology-Tyler — Tyler, Texas, United States (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital, Yonsei University Health System — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Bundang Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Ibrahim Qazi, PharmD
- Email: ibrahim.qazi@torlbio.com
- Phone: 310-348-9636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.