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

Sponsor

Trishula Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06119217

Collaborator

AbbVie (Industry)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Combination Product: TTX-030, nab-paclitaxel and gemcitabine Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine Combination Product: Nab-Paclitaxel and gemcitabine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, Parallel Group StudyRandomized, Parallel Group Study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2027

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 TTX-030 plus nab-paclitaxel and gemcitabine	Combination Product: TTX-030, nab-paclitaxel and gemcitabine Dose and schedule per protocol
Experimental: Arm 2 TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine	Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine Dose and schedule per protocol
Active Comparator: Arm 3 Nab-Paclitaxel and gemcitabine	Combination Product: Nab-Paclitaxel and gemcitabine Dose and schedule per protocol

Arm

Intervention/Treatment

Experimental: Arm 1

TTX-030 plus nab-paclitaxel and gemcitabine

Combination Product: TTX-030, nab-paclitaxel and gemcitabine

Dose and schedule per protocol

Experimental: Arm 2

TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine

Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine

Dose and schedule per protocol

Active Comparator: Arm 3

Nab-Paclitaxel and gemcitabine

Combination Product: Nab-Paclitaxel and gemcitabine

Dose and schedule per protocol

Outcome Measures

Primary Outcome Measures

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

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)
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Abbreviated Inclusion Criteria:

Age 18 years or older, is willing and able to provide informed consent
Histologically or cytologically confirmed diagnosis of metastatic PDAC.
No prior systemic treatment for metastatic disease.
Evidence of measurable disease per RECIST 1.1.
Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Abbreviated Exclusion Criteria:

History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody
Use of investigational agent within 14 days prior to the first dose of study drug
History of autoimmune disease
Subject has received live vaccine within 28 days prior to the first dose of study drug
Has uncontrolled intercurrent illness