TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers

• ClinicalTrials.gov Identifier: NCT03884556
• Recruitment Status: Active, not recruiting
• First Posted: March 21, 2019
• Last Update Posted: April 26, 2022
• Sponsor: Trishula Therapeutics, Inc.
• Information provided by (Responsible Party): Trishula Therapeutics, Inc.

Tracking Information

• First Submitted Date: March 16, 2019
• First Posted Date: March 21, 2019
• Last Update Posted Date: April 26, 2022
• Actual Study Start Date: April 10, 2019
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2019)

Recommended Phase 2 Dose (RP2D) [ Time Frame: 1 cycle (each cycle is 21-28 days) ]

Assess the safety profile, dose limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TTX-030 when administered intravenously (IV) as a single agent and in combination with agents in specified regimens to subjects with advanced solid tumor malignancies or lymphoma

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 20, 2019)

• Anti-tumor activity [ Time Frame: Through study completion, an average of 1 year ]
  Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens
• Maximum Plasma Concentration (Cmax) [ Time Frame: Cycles 1-3 (each cycle is 21-28 days) ]
  Pharmacokinetics (PK) of TTX-030
• CD39 Expression [ Time Frame: Through study completion, an average of 1 year ]
  Pharmacodynamic (PD) biomarkers relating to mechanism of action and immune responses

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
• Official Title: Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

Brief Summary

This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.

This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Solid Tumor
• Lymphoma

Intervention

• Drug: TTX-030
  Variable dose and schedule
• Drug: Pembrolizumab
  Dose and schedule per standard of care
• Drug: Gemcitabine
  Dose and schedule per standard of care
• Drug: nab paclitaxel
  Dose and schedule per standard of care

Study Arms

• Experimental: Arm 1, Single Agent
  TTX-030
  Intervention: Drug: TTX-030
• Experimental: Arm 2, Anti-PD-1 Combination
  TTX-030 plus pembrolizumab
  Interventions:

  • Drug: TTX-030
  • Drug: Pembrolizumab
• Experimental: Arm 4, Chemotherapy Combination
  TTX-030 plus gemcitabine plus nab-paclitaxel
  Interventions:

  • Drug: TTX-030
  • Drug: Gemcitabine
  • Drug: nab paclitaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 19, 2022): 56
• Original Estimated Enrollment (submitted: March 20, 2019): 100
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Abreviated Inclusion Criteria

1. Advanced solid tumor malignancy or relapsed/refractory lymphoma, or

   • eligible to receive single-agent pembrolizumab as standard of care, or
   • eligible to receive single-agent docetaxel as standard of care, or
   • advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care.
2. Age 18 years or older, is willing and able to provide informed consent
3. Evidence of measurable disease
4. Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Abbreviated Exclusion Criteria

1. History of allergy or hypersensitivity to study treatment components. Patients 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03884556
• Other Study ID Numbers: TTX-030-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Trishula Therapeutics, Inc.
• Original Responsible Party: Tizona Therapeutics, Inc
• Current Study Sponsor: Trishula Therapeutics, Inc.
• Original Study Sponsor: Tizona Therapeutics, Inc
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Trishula Therapeutics, Inc.
• Verification Date: April 2022