TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

• ClinicalTrials.gov Identifier: NCT04306900
• Recruitment Status: Active, not recruiting
• First Posted: March 13, 2020
• Last Update Posted: June 14, 2022
• Sponsor: Trishula Therapeutics, Inc.
• Collaborator: AbbVie
• Information provided by (Responsible Party): Trishula Therapeutics, Inc.

Tracking Information

• First Submitted Date: March 4, 2020
• First Posted Date: March 13, 2020
• Last Update Posted Date: June 14, 2022
• Actual Study Start Date: March 30, 2020
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 10, 2020)

Adverse Events [ Time Frame: Through study completion, an average of 1 year ]

Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 10, 2020)

• Objective Response Rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]
  ORR is defined as the proportion of subjects with CR or PR
• Duration of response (DoR) [ Time Frame: Through study completion, an average of 1 year ]
  DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
• Disease control rate (DCR) [ Time Frame: Through study completion, an average of 1 year ]
  DCR is defined as the proportion of subjects with CR, PR, or SD
• Progression-free survival (PFS) [ Time Frame: Through study completion, an average of 1 year ]
  PFS is measured from documentation of progression or death from any cause, whichever occurs first
• Pharmacokinetics (PK) [ Time Frame: Cycles 1-4 (each cycle is 21-28 days) ]
  Serum concentrations of TTX-030 will be tabulated

• 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 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
• Official Title: Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Brief Summary

This is a phase 1/1b study of TTX-030 in combination therapy, 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, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor, Adult

Intervention

• Combination Product: TTX-030, budigalimab and mFOLFOX6
  Dose and schedule per protocol
• Combination Product: TTX-030, budigalimab and docetaxel
  Dose and schedule per protocol
• Combination Product: TTX-030 and mFOLFOX6
  Dose and schedule per protocol
• Combination Product: TTX-030 and budigalimab
  Dose and schedule per protocol
• Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
  Dose and schedule per protocol
• Combination Product: TTX-030 and pembrolizumab
  Dose and schedule per protocol
• Combination Product: TTX-030, nab-paclitaxel and gemcitabine
  Dose and schedule per protocol
• Combination Product: Budigalimab and mFOLFOX6
  Dose and schedule per protocol

Study Arms

• Experimental: Combo 1
  TTX-030 plus budigalimab plus mFOLFOX6
  Intervention: Combination Product: TTX-030, budigalimab and mFOLFOX6
• Experimental: Combo 2
  TTX-030 plus budigalimab plus docetaxel
  Intervention: Combination Product: TTX-030, budigalimab and docetaxel
• Experimental: Combo 3
  TTX-030 plus mFOLFOX6
  Intervention: Combination Product: TTX-030 and mFOLFOX6
• Experimental: Combo 4
  TTX-030 plus pembrolizumab
  Intervention: Combination Product: TTX-030 and pembrolizumab
• Experimental: Combo 5
  TTX-030 plus budigalimab (selected tumors evaluated in expansion)
  Intervention: Combination Product: TTX-030 and budigalimab
• Experimental: Combo 6
  TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine
  Intervention: Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
• Experimental: Combo 7
  TTX-030 plus nab-paclitaxel + gemcitabine
  Intervention: Combination Product: TTX-030, nab-paclitaxel and gemcitabine
• Experimental: Combo 8
  Budigalimab plus mFOLFOX6
  Intervention: Combination Product: Budigalimab and mFOLFOX6

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 23, 2021): 185
• Original Estimated Enrollment (submitted: March 10, 2020): 152
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Abbreviated Inclusion Criteria:

1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
3. Life expectancy > 12 weeks
4. 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 to 110 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of, United States

Administrative Information

• NCT Number: NCT04306900
• Other Study ID Numbers: TTX-030-002
• 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: AbbVie
• Investigators: Not Provided
• PRS Account: Trishula Therapeutics, Inc.
• Verification Date: June 2022