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

Solid Tumor, Adult Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306900
• Other study ID #: TTX-030-002
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2020
• Est. completion date: March 27, 2024

Study information

• Verified date: April 2024
• Source: Trishula Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: March 27, 2024
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Gangnam-gu	Seoul
Korea, Republic of	National Cancer Center	Ilsandong-gu	Goyang-si, Gyeonggi-do
Korea, Republic of	Severance Hospital Yonsei University	Seodaemun-gu	Seoul
Korea, Republic of	National Cancer Center	Seogu	Busan
Korea, Republic of	Seoul National University	Seongnam-si Bundan-gu	Kyunggi-do
Korea, Republic of	Asan Medical Center	Songpa-gu	Seoul
United States	Montefiore Medical Center	Bronx	New York
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	IACT Health - John B. Amos Cancer Center	Columbus	Georgia
United States	City of Hope Medical Center Clinical Trials Office	Duarte	California
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	West Cancer Center and Research Institute	Germantown	Tennessee
United States	Prisma-Health Cancer Institute	Greenville	South Carolina
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UCLA Hematology/Oncology	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine	Miami	Florida
United States	Froedtert Hospital & Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Ocala Oncology Center PL	Ocala	Florida
United States	Nebraska Cancer Center Oncology Hematology West P.C.	Omaha	Nebraska
United States	Chao Family Comprehensive CC, UCI	Orange	California
United States	Orlando Health UF Health Cancer Center	Orlando	Florida
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	Hunstman Cancer Intitute	Salt Lake City	Utah
United States	NEXT Oncology	San Antonio	Texas
United States	HonorHealth Research Institute	Scottsdale	Arizona
United States	University of Toledo	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Trishula Therapeutics, Inc.	AbbVie

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	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.	Through study completion, an average of 1 year
Secondary	Objective Response Rate (ORR)	ORR is defined as the proportion of subjects with CR or PR	Through study completion, an average of 1 year
Secondary	Duration of response (DoR)	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.	Through study completion, an average of 1 year
Secondary	Disease control rate (DCR)	DCR is defined as the proportion of subjects with CR, PR, or SD	Through study completion, an average of 1 year
Secondary	Progression-free survival (PFS)	PFS is measured from documentation of progression or death from any cause, whichever occurs first	Through study completion, an average of 1 year
Secondary	Pharmacokinetics (PK)	Serum concentrations of TTX-030 will be tabulated	Cycles 1-4 (each cycle is 21-28 days)