Clinical trial · Interventional
TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
| TTX-080 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- Phase 1a, Monotherapy Dose Escalation
- interventionNames
- Drug: TTX-080
- type
- EXPERIMENTAL
- label
- Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC)
- description
- Arm 1 will enroll subjects with advanced/metastatic, prior checkpoint inhibitor treated Head and Neck Squamous Cell Carcinoma (HNSCC) \[Closed\]
- interventionNames
- Drug: TTX-080
- Drug: pembrolizumab
- type
- EXPERIMENTAL
- label
- Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC)
- description
- Arm 2 will enroll subjects with advanced/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) \[Closed\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available