Description:
This is a Phase 1, multicenter, open-label, multiple-dose, dose-escalation and dose-expansion
study to evaluate the safety, tolerability, PK, and pharmacodynamics of TTX-080 monotherapy
in subjects with advanced or metastatic solid tumors known to express HLA-G.
This first-in-human (FIH) study has been designed to evaluate the safety, tolerability, and
preliminary antitumor activity of TTX-080 as monotherapy in adults with unresectable or
metastatic solid tumors known to express HLA-G.
Title
- Brief Title: TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
- Official Title: A First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
TTX-080-001
- NCT ID:
NCT04485013
Conditions
Interventions
Drug | Synonyms | Arms |
---|
TTX-080 | | Monotherapy Dose Escalation |
Purpose
This is a Phase 1, multicenter, open-label, multiple-dose, dose-escalation and dose-expansion
study to evaluate the safety, tolerability, PK, and pharmacodynamics of TTX-080 monotherapy
in subjects with advanced or metastatic solid tumors known to express HLA-G.
This first-in-human (FIH) study has been designed to evaluate the safety, tolerability, and
preliminary antitumor activity of TTX-080 as monotherapy in adults with unresectable or
metastatic solid tumors known to express HLA-G.
Trial Arms
Name | Type | Description | Interventions |
---|
Monotherapy Dose Escalation | Experimental | | |
Eligibility Criteria
Abbreviated Inclusion Criteria:
1. Subject with histological or cytological diagnosis of advanced/metastatic cancer
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
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 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Recommended Phase 2 Dose (RP2D) |
Time Frame: | 1 cycle (each cycle is 21 days) |
Safety Issue: | |
Description: | To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule |
Secondary Outcome Measures
Measure: | Pharmacokinetics (PK) |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Serum concentrations of TTX-080 will be tabulated |
Measure: | Immunogenicity |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Serum levels of antidrug antibody (ADA) against TTX-080 |
Measure: | Objective tumor response |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Measure the proportion of subjects with ORR, DoR, and PFS |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Tizona Therapeutics, Inc |
Trial Keywords
- HLA-G
- TTX-080
- Advanced Solid Tumor
- Cancer
- Ovarian Cancer
- Endometrial Cancer
- Cervical Cancer
- Kidney Cancer
- Head and Neck Squamous Cell Carcinoma
- Squamous Cell Lung Cancer
- Prostate Cancer
- Colorectal Cancer
- Gastric Cancer
- Breast Cancer
- Bladder Cancer
- Lung Adenocarcinoma
- Melanoma
- Metastatic Solid Tumor
Last Updated
July 2, 2021