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Monoclonal Antibodies
TTX-030 Combination Therapy for Cancer
Phase 1
Waitlist Available
Research Sponsored by Trishula Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types
Age 18 years or older, willing and able to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is studying a new drug, TTX-030, to see if it is safe and effective when used in combination with other immunotherapies and/or standard chemotherapies to treat cancer.
Who is the study for?
Adults over 18 with certain advanced solid tumors, able to consent, and have a life expectancy of more than 12 weeks can join. They should be relatively active (ECOG status 0-1). Those with severe autoimmune diseases, allergies to trial drugs, recent other investigational treatments, ongoing steroid or immunosuppressive therapy, or another active cancer needing treatment cannot participate.Check my eligibility
What is being tested?
The study is testing TTX-030 in combination with various immunotherapies and chemotherapies like budigalimab and mFOLFOX6. It's an early-phase trial assessing the safety and how well these combinations work against tumors by altering the immune environment within the tumor.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system due to antibody presence which could lead to inflammation in different body parts. Chemotherapy may cause nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed to be advanced and cannot be removed by surgery.
Select...
I am 18 or older and can give my consent.
Select...
I am fully active or can carry out light work.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DoR)
Objective Response Rate (ORR)
+2 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Combo 8Experimental Treatment1 Intervention
Budigalimab plus mFOLFOX6
Group II: Combo 7Experimental Treatment1 Intervention
TTX-030 plus nab-paclitaxel + gemcitabine
Group III: Combo 6Experimental Treatment1 Intervention
TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine
Group IV: Combo 5Experimental Treatment1 Intervention
TTX-030 plus budigalimab (selected tumors evaluated in expansion)
Group V: Combo 4Experimental Treatment1 Intervention
TTX-030 plus pembrolizumab
Group VI: Combo 3Experimental Treatment1 Intervention
TTX-030 plus mFOLFOX6
Group VII: Combo 2Experimental Treatment1 Intervention
TTX-030 plus budigalimab plus docetaxel
Group VIII: Combo 1Experimental Treatment1 Intervention
TTX-030 plus budigalimab plus mFOLFOX6
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TTX-030, budigalimab and mFOLFOX6
2020
Completed Phase 1
~190
TTX-030 and pembrolizumab
2020
Completed Phase 1
~190
TTX-030, budigalimab and docetaxel
2020
Completed Phase 1
~190
TTX-030, nab-paclitaxel and gemcitabine
2020
Completed Phase 1
~190
TTX-030 and budigalimab
2020
Completed Phase 1
~190
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
2020
Completed Phase 1
~190
TTX-030 and mFOLFOX6
2020
Completed Phase 1
~190
Budigalimab and mFOLFOX6
2020
Completed Phase 1
~190
Find a Location
Who is running the clinical trial?
AbbVieIndustry Sponsor
954 Previous Clinical Trials
500,920 Total Patients Enrolled
Trishula Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
236 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed to be advanced and cannot be removed by surgery.I am 18 or older and can give my consent.I do not have any other active cancers or serious illnesses that are not under control.I am fully active or can carry out light work.I am currently on high-dose steroids or other drugs that weaken my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Combo 1
- Group 2: Combo 7
- Group 3: Combo 2
- Group 4: Combo 3
- Group 5: Combo 4
- Group 6: Combo 5
- Group 7: Combo 8
- Group 8: Combo 6
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Florida
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
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