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

Phase 2

Active, not recruiting

• Conditions: Pancreatic Cancer
• Interventions: Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine; Combination Product: TTX-030, nab-paclitaxel and gemcitabine; Combination Product: Nab-Paclitaxel and gemcitabine

• Registration Number: NCT06119217
• Lead Sponsor: Trishula Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-07
• Study Start: 2024-03-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-02
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 194

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	TTX-030, budigalimab, nab-paclitaxel and gemcitabine	TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
Arm 1	TTX-030, nab-paclitaxel and gemcitabine	TTX-030 plus nab-paclitaxel and gemcitabine
Arm 3	Nab-Paclitaxel and gemcitabine	Nab-Paclitaxel and gemcitabine

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) - Biomarker Enriched Population	Through study completion, an average of 1 year	PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Investigative Site; 🇨🇳 Taoyuan, Taiwan

Investigative SIte; 🇺🇸 Hot Springs, Arkansas, United States