Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

Pancreatic Cancer Clinical Trial

Official title:

An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119217
• Other study ID #: TTX-030-003
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: Trishula Therapeutics, Inc.
• Contact: Trishula Therapeutics, Inc.
• Phone: +1 888-480-0554
• Email: clinicaltrials[@]trishulatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Abbreviated Inclusion Criteria:

1. Age 18 years or older, is willing and able to provide informed consent

2. Histologically or cytologically confirmed diagnosis of metastatic PDAC.

3. No prior systemic treatment for metastatic disease.

4. Evidence of measurable disease per RECIST 1.1.

5. Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.

6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Abbreviated Exclusion Criteria:

1. History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody

2. Use of investigational agent within 14 days prior to the first dose of study drug

3. History of autoimmune disease

4. Subject has received live vaccine within 28 days prior to the first dose of study drug

5. Has uncontrolled intercurrent illness

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

Combination Product:
• TTX-030, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
• TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
• Nab-Paclitaxel and gemcitabine
Dose and schedule per protocol

Locations

Country	Name	City	State
Korea, Republic of	Investigative Site	Goyang-si
Korea, Republic of	Investigative Site	Seongam
Korea, Republic of	Investigative Site	Seoul
Korea, Republic of	Investigative Site	Seoul
United States	Investigative Site	Arlington	Virginia
United States	Investigative Site	Asheville	North Carolina
United States	Investigative Site	Atlanta	Georgia
United States	Investigative Site	Columbia	Maryland
United States	Investigative Site	Columbus	Ohio
United States	Investigative Site	Dallas	Texas
United States	Investigative Site	Denver	Colorado
United States	Investigative Site	Florham Park	New Jersey
United States	Investigative Site	Horsham	Pennsylvania
United States	Investigative SIte	Hot Springs	Arkansas
United States	Investigative Site	Los Angeles	California
United States	Investigative Site	Norfolk	Virginia
United States	Investigative Site	Roanoke	Virginia
United States	Investigative Site	Saint Petersburg	Florida
United States	Investigative Site	San Antonio	Texas
United States	Investigative Site	Tallahassee	Florida
United States	Investigative Site	Tucson	Arizona
United States	Investigative Site	Tyler	Texas
United States	Investigative Site	West Palm Beach	Florida

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	Progression-free survival (PFS) - Biomarker Enriched Population	PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first	Through study completion, an average of 1 year
Secondary	Progression-free survival (PFS) - Overall Population	PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first	Through study completion, an average of 1 year
Secondary	Objective Response Rate (ORR)	ORR is defined as the percentage of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR)	Through study completion, an average of 1 year
Secondary	Duration of Response (DoR)	DoR will be defined as the time from the first documentation of disease response (CR or PR) until first documentation of progression or death from any cause, whichever comes first.	Through study completion, an average of 1 year
Secondary	Overall Survival (OS)	OS is defined as the time from randomization until death due to any cause.	Through study completion, an average of 1 year
Secondary	Adverse Events	Type, severity, and frequency of treatment-emergent AEs	Through study completion, an average of 1 year