Open
Actively Recruiting
TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
About
Brief Summary
TTX-080-001 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 arms.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 AND life expectancy of at least 12 weeks
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
Colorectal Cancer
Liver Cancer
Lung Cancer
Other Cancer
Prostate Cancer
Stomach Cancer
Principal Investigator
Randolph Hecht
Contact
Location
- UCLA Santa Monica
- UCLA Torrance
- UCLA Westlake Village
- UCLA Westwood