NCT04485013 TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
| NCT ID | NCT04485013 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Tizona Therapeutics, Inc |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2020-07-14 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 240 participants in total. It began in 2020-07-14 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.
Eligibility Criteria
Abbreviated Inclusion Criteria: 1. Subject with histological diagnosis of advanced/metastatic cancer \[currently enrolling in CRC only\] 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 AND life expectancy of at least 12 weeks 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04485013 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04485013 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04485013 currently recruiting?
Yes, NCT04485013 is actively recruiting participants. Contact the research team at clinicaltrials@tizonatx.com for enrollment information.
Where is the NCT04485013 trial being conducted?
This trial is being conducted at Tucson, United States, Los Angeles, United States, Newport Beach, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT04485013 clinical trial?
NCT04485013 is sponsored by Tizona Therapeutics, Inc. The trial plans to enroll 240 participants.
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