Open Actively Recruiting

TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers

About

Brief Summary

TTX-080-01 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor) or cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies.

The study is enrolling in the dose expansion cohorts.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

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

Abbreviated Inclusion Criteria:

  • Subject with histological diagnosis of advanced/metastatic cancer
  • Age 18 years or older, is willing and able to provide informed consent
  • Evidence of measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Abbreviated Exclusion Criteria:

  • History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
  • Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study
  • Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
  • History of severe autoimmune disease
  • Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

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Study Stats
Protocol No.
21-001557
Category
Hematology-Oncology
Oncology
Principal Investigator
Randolph Hecht
Contact
Rachel Andes
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04485013
For detailed technical eligibility, visit ClinicalTrials.gov.