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HLA-G Inhibitor

TTX-080 +/− Cetuximab/Pembrolizumab for Cancer

Phase 1
Waitlist Available
Research Sponsored by Tizona Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks
Subject with histological diagnosis of advanced/metastatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial is testing a new drug (TTX-080) to see if it is safe and effective in treating cancer. The drug is being tested alone and in combination with two other drugs (pembrolizumab and cetuximab) to see if it improves treatment.

Who is the study for?
This trial is for adults with advanced or metastatic cancer who are in fairly good health (able to perform daily activities without significant assistance) and have a life expectancy of at least 12 weeks. They must be able to consent to the study, not have severe allergies to treatment components, no recent use of other investigational drugs, no high-dose steroids or immunosuppressants, and no uncontrolled illnesses.Check my eligibility
What is being tested?
The TTX-080 clinical trial is testing the safety and optimal dosing of a new drug called TTX-080 alone or combined with pembrolizumab or cetuximab in patients with resistant cancers. It's an early-phase study where researchers gradually increase doses to find what's safe and potentially effective.See study design
What are the potential side effects?
Possible side effects include allergic reactions related to the treatments' components, immune system-related issues due to HLA-G inhibition by TTX-080, infusion reactions from monoclonal antibodies like pembrolizumab/cetuximab, fatigue, skin reactions from EGFR inhibition by cetuximab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am mostly active and my doctor expects me to live at least 12 more weeks.
Select...
My cancer is advanced and has spread to other parts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1. To determine the anti-tumor activity of TTX-080 by objective response rate [complete response + partial response) for each tumor arm per RECIST 1.1
Secondary outcome measures
AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for TTX-080
AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for TTX-080
Adverse events (AEs) as characterized by the incidence, type, frequency, severity (graded according to NCI-CTCAE v5.0), timing, seriousness, and relationship to investigational product, and/or combination therapy, and/or individual approved therapies
+6 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)Experimental Treatment1 Intervention
Arm 6 will enroll subjects with advanced/metastatic non-small cell lung cancer (NSCLC)
Group II: Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC)Experimental Treatment1 Intervention
Arm 3 will enroll subjects with advanced/metastatic colorectal cancer (CRC)
Group III: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC)Experimental Treatment2 Interventions
Arm 7 will enroll subjects with advanced/metastatic prior checkpoint inhibitor treated non-small cell lung cancer (NSCLC)
Group IV: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC)Experimental Treatment2 Interventions
Arm 1 will enroll subjects with advanced/metastatic, prior checkpoint inhibitor treated Head and Neck Squamous Cell Carcinoma (HNSCC)
Group V: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC)Experimental Treatment2 Interventions
Arm 2 will enroll subjects with advanced/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Group VI: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), prior anti-EGFR therapyExperimental Treatment2 Interventions
Arm 4 will enroll subjects with advanced/metastatic MSI-L/MSS, KRAS wild-type colorectal cancer (CRC) who have progressed on a prior anti-EGFR therapy
Group VII: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), no prior anti-EGFR therapyExperimental Treatment2 Interventions
Arm 5 will enroll subjects with advanced/metastatic MSI-L/MSS, KRAS wild type colorectal cancer (CRC) who have not received a prior anti-EGFR therapy
Group VIII: Phase 1b, Dose Expansion: TTX-080 as monotherapy OR in combination with pembrolizumabExperimental Treatment2 Interventions
Arm 8: TTX-080 monotherapy: Advanced/metastatic, prior checkpoint inhibitor treated renal cell carcinoma with predominance of clear cell component Advanced/metastatic acral melanoma Arm 8: TTX-080 in combination with pembrolizumab: • Advanced/metastatic triple-negative breast cancer (estrogen and progesterone receptor negative and HER2 negative) who has received a prior checkpoint inhibitor
Group IX: Phase 1a, Monotherapy Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cetuximab
2000
Completed Phase 3
~7290
pembrolizumab
2017
Completed Phase 3
~5750

Find a Location

Who is running the clinical trial?

Tizona Therapeutics, IncLead Sponsor

Media Library

TTX-080 (HLA-G Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04485013 — Phase 1
Cancer Research Study Groups: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), prior anti-EGFR therapy, Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), no prior anti-EGFR therapy, Phase 1b, Dose Expansion: TTX-080 as monotherapy OR in combination with pembrolizumab, Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC), Phase 1a, Monotherapy Dose Escalation, Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC), Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC), Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC), Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)
Cancer Clinical Trial 2023: TTX-080 Highlights & Side Effects. Trial Name: NCT04485013 — Phase 1
TTX-080 (HLA-G Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04485013 — Phase 1
~50 spots leftby Jun 2025
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