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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    200
  • sponsor
    Tizona Therapeutics, Inc
Updated on 29 July 2022
cancer
measurable disease
metastasis
EGFR
cetuximab
primary cancer
solid tumour
histological diagnosis

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.

The study is enrolling in the dose expansion cohorts.

Description

TTX-080 is a fully human mAb designed to block the interaction of HLA-G with its known ligands, ILT2 and ILT4 molecules. The Phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD or OBD and the RP2D of TTX-080 when administered as a single agent. The Phase 1b is a dose expansion of TTX-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory/resistant solid malignancies, including Head and Neck squamous cell carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Colorectal cancer (CRC), and triple negative breast cancer (TNBC). Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of TTX-080, and preliminary efficacy of TTX-080 as a monotherapy and in combination with pembrolizumab or cetuximab.

The study is enrolling in the dose expansion cohorts.

Details
Condition Cancer
Treatment Cetuximab, Pembrolizumab, TTX-080
Clinical Study IdentifierNCT04485013
SponsorTizona Therapeutics, Inc
Last Modified on29 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject with histological diagnosis of advanced/metastatic cancer
Age 18 years or older, is willing and able to provide informed consent
Evidence of measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria

History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study
Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
History of severe autoimmune disease
Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
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