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Monoclonal Antibodies

Arm 1 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) - Biomarker Enriched Population

Secondary outcome measures

Adverse Events

Duration of Response (DoR)

Objective Response Rate (ORR)

+2 more

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, nab-paclitaxel and gemcitabine

2020

Completed Phase 1

~190

TTX-030, budigalimab, nab-paclitaxel and gemcitabine

2020

Completed Phase 1

~190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

958 Previous Clinical Trials

502,210 Total Patients Enrolled

Trishula Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

241 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"Indeed, the information on clinicaltrials.gov denotes that this trial is presently seeking participants. The study was first listed on March 1st, 2024 and most recently updated on March 14th, 2024. Recruitment aims to enroll a total of 180 patients across ten different sites."

Answered by AI

What is the total number of participants being recruited for this clinical investigation?

"Affirmative, the details on clinicaltrials.gov indicate that this investigation is actively enrolling participants. Initially shared on March 1st, 2024, with the last update made on March 14th, 2024; it aims to enroll a total of 180 patients distributed among ten locations."

Answered by AI

Has the second arm of this study been granted approval by the FDA?

"In this Phase 2 clinical trial, Arm 2 has been rated a 2 for safety by our team at Power. This score indicates that while there is some existing safety data, efficacy evidence is yet to be established."

Answered by AI

Are multiple medical facilities in the area conducting this particular research study?

"Currently, the trial is ongoing at 10 sites. These include Florham Park, Tucson, and West Palm Beach among other cities in different regions. Opting for a center close to your location will help reduce travel requirements if you decide to take part."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06119217.

All > Tucson