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

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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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
21-001886
Category
Bladder Cancer
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Pancreatic Cancer
Sarcoma
Stomach Cancer
Contact
LISA-MARIA YONEMOTO
Location
  • TRIO-US - Ft. Wayne IN
  • TRIO-US - Fullerton
  • TRIO-US - Redondo Beach
  • UCLA San Luis Obispo
  • UCLA Santa Barbara
  • UCLA Santa Monica
For Providers
NCT No.
NCT05159440
For detailed technical eligibility, visit ClinicalTrials.gov.