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

Phase 1

Completed

• Conditions: Solid Tumor, Adult
• Interventions: Combination Product: TTX-030 and mFOLFOX6; Combination Product: TTX-030, budigalimab and mFOLFOX6; Combination Product: TTX-030 and pembrolizumab; Combination Product: TTX-030, nab-paclitaxel and gemcitabine; Combination Product: TTX-030, budigalimab and docetaxel; Combination Product: TTX-030 and budigalimab; Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine; Combination Product: Budigalimab and mFOLFOX6

• Registration Number: NCT04306900
• Lead Sponsor: Trishula Therapeutics, Inc.

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Study Start: 2020-03-30
• Primary Completion: 2022-11-30
• Study Completion: 2024-03-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adverse Events	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.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	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)	Through study completion, an average of 1 year	PFS is measured from documentation of progression or death from any cause, whichever occurs first
Duration of response (DoR)	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.
Pharmacokinetics (PK)	Cycles 1-4 (each cycle is 21-28 days)	Serum concentrations of TTX-030 will be tabulated
Objective Response Rate (ORR)	Through study completion, an average of 1 year	ORR is defined as the proportion of subjects with CR or PR

Trial Locations

Locations (31)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Toledo; 🇺🇸 Toledo, Ohio, United States

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States

Virginia Cancer Specialists; 🇺🇸 Fairfax, Virginia, United States

National Cancer Center; 🇰🇷 Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of

City of Hope Medical Center Clinical Trials Office; 🇺🇸 Duarte, California, United States

Ocala Oncology Center PL; 🇺🇸 Ocala, Florida, United States

Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Chao Family Comprehensive CC, UCI; 🇺🇸 Orange, California, United States

West Cancer Center and Research Institute; 🇺🇸 Germantown, Tennessee, United States

UCLA Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

Hunstman Cancer Intitute; 🇺🇸 Salt Lake City, Utah, United States

Froedtert Hospital & Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

IACT Health - John B. Amos Cancer Center; 🇺🇸 Columbus, Georgia, United States

UC Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

Orlando Health UF Health Cancer Center; 🇺🇸 Orlando, Florida, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Severance Hospital Yonsei University; 🇰🇷 Seodaemun-gu, Seoul, Korea, Republic of

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Seoul National University; 🇰🇷 Seongnam-si Bundan-gu, Kyunggi-do, Korea, Republic of

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Samsung Medical Center; 🇰🇷 Gangnam-gu, Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Songpa-gu, Seoul, Korea, Republic of

Nebraska Cancer Center Oncology Hematology West P.C.; 🇺🇸 Omaha, Nebraska, United States

Prisma-Health Cancer Institute; 🇺🇸 Greenville, South Carolina, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States