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Monoclonal Antibodies

TTX-030 + Chemotherapy for Pancreatic Cancer

Phase 2
Recruiting
Research Sponsored by Trishula Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effectiveness and safety of TTX-030 with or without budigalimab along with chemotherapy in patients with metastatic PDAC who have not received prior treatment for metastatic

Who is the study for?
This trial is for adults over 18 with metastatic pancreatic cancer (mPDAC) who haven't had treatment for their advanced disease yet. They should be able to receive standard chemotherapy and have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory.
What is being tested?
The study tests TTX-030 combined with standard chemo (nab-paclitaxel and gemcitabine), both with and without another drug called budigalimab, against just the chemo alone. It's to see which combination works best for treating mPDAC.
What are the potential side effects?
Possible side effects include reactions related to the immune system, such as inflammation in different body parts, infusion-related reactions from the drugs being administered into the vein, fatigue, nausea, low blood cell counts increasing infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) - Biomarker Enriched Population
Secondary study objectives
Adverse Events
Duration of Response (DoR)
Objective Response Rate (ORR)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment1 Intervention
TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
Group II: Arm 1Experimental Treatment1 Intervention
TTX-030 plus nab-paclitaxel and gemcitabine
Group III: Arm 3Active Control1 Intervention
Nab-Paclitaxel and gemcitabine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
2020
Completed Phase 1
~190
TTX-030, nab-paclitaxel and gemcitabine
2020
Completed Phase 1
~190

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor
1,035 Previous Clinical Trials
522,871 Total Patients Enrolled
Trishula Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
241 Total Patients Enrolled
~120 spots leftby Feb 2027
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