Clinical Trials /

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

NCT04485013

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
TTX-080Monotherapy 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

NameTypeDescriptionInterventions
Monotherapy Dose EscalationExperimental
  • TTX-080

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 29, 2020