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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04485013
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : July 31, 2020
Information provided by (Responsible Party):
Tizona Therapeutics, Inc

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: TTX-080 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : February 1, 2022

Arm Intervention/treatment
Experimental: Monotherapy Dose Escalation Drug: TTX-080
Variable dose (Q3W)

Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) [ Time Frame: 1 cycle (each cycle is 21 days) ]
    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 :
  1. Pharmacokinetics (PK) [ Time Frame: Through study completion, an average of 1 year ]
    Serum concentrations of TTX-080 will be tabulated

  2. Immunogenicity [ Time Frame: Through study completion, an average of 1 year ]
    Serum levels of antidrug antibody (ADA) against TTX-080

  3. Objective tumor response [ Time Frame: Through study completion, an average of 1 year ]
    Measure the proportion of subjects with ORR, DoR, and PFS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04485013

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Contact: Tizona Therapeutics, Inc. 888-585-2990

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United States, Nebraska
Nebraska Cancer Center Oncology Hematology West P.C. Recruiting
Omaha, Nebraska, United States, 68130
Contact: Megan Meays, M.A. CCRC    402-691-6971   
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Sarah Gomez    210-580-9521   
Sponsors and Collaborators
Tizona Therapeutics, Inc
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Responsible Party: Tizona Therapeutics, Inc Identifier: NCT04485013    
Other Study ID Numbers: TTX-080-001
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tizona Therapeutics, Inc:
Advanced Solid Tumor
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
Metastatic Solid Tumor
Additional relevant MeSH terms:
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