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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tizona Therapeutics, Inc
• Treatments: Cetuximab; Pembrolizumab

Criteria

Abbreviated Inclusion Criteria:

1. Subject with histological diagnosis of advanced/metastatic cancer

2. Age 18 years or older, is willing and able to provide informed consent

3. Evidence of measurable disease

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Abbreviated Exclusion Criteria:

1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody

2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study

3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy

4. History of severe autoimmune disease

5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment