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

Conditions

• Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TTX-080 — DRUG
  Variable dose (Q3W)
• TTX-080 — DRUG
  Specified dose (Q3W)
• pembrolizumab — DRUG
  Specified dose (Q3W)
• cetuximab — DRUG
  Specified dose on specified days
• FOLFIRI — DRUG
  Specified dose (Q2W)
• cetuximab — DRUG
  Specified dose (Q2W)
• TTX-080 — DRUG
  Specified dose (Q2W)

Study Details

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.

Key Dates

Start date

Jul 14, 2020

Status verified

Dec 2025

Primary completion

Jun 1, 2027

Completion

Jun 1, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a, Monotherapy Dose Escalation
• Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC)
  Arm 1 will enroll subjects with advanced/metastatic, prior checkpoint inhibitor treated Head and Neck Squamous Cell Carcinoma (HNSCC) \[Closed\]
• Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC)
  Arm 2 will enroll subjects with advanced/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) \[Closed\]
• Experimental: Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC)
  Arm 3 will enroll subjects with advanced/metastatic colorectal cancer (CRC) \[Closed\]
• Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), prior anti-EGFR therapy
  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 \[Closed\]
• Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), no prior anti-EGFR therapy
  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 \[Closed\]
• Experimental: Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)
  Arm 6 will enroll subjects with advanced/metastatic non-small cell lung cancer (NSCLC) \[Closed\]
• Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC)
  Arm 7 will enroll subjects with advanced/metastatic prior checkpoint inhibitor treated non-small cell lung cancer (NSCLC) \[Closed\]
• Experimental: Phase 1b, Dose Expansion: TTX-080 as monotherapy OR in combination with pembrolizumab
  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 \[Closed\]
• Experimental: TTX-080 in combination with FOLFIRI plus cetuximab
  Arm 9: TTX-080 in combination with FOLFIRI plus cetuximab Randomized Arms in subjects with metastatic RAS, BRAF and HER2 wild type colorectal cancer (CRC) who have been received oxaliplatin and 5-FU based chemotherapy in the first line or adjuvant (relapse within 6 months) setting. Prior bevacizumab allowed. No prior EGFR inhibitor.
• Experimental: FOLFIRI plus cetuximab
  Arm 10: FOLFIRI plus cetuximab Randomized Arms in subjects with metastatic RAS, BRAF and HER2 wild type colorectal cancer (CRC) who have been received oxaliplatin and 5-FU based chemotherapy in the first line or adjuvant (relapse within 6 months) setting. Prior bevacizumab allowed. No prior EGFR inhibitor.

Primary Outcome Measure

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 [ Time Frame: Up to 48 months ]

Central Contacts

• Tizona Therapeutics, Inc.
  888-585-2990
  [email protected]

Locations (41)

Find similar trials in Tucson, AZ

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