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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
Must not have
Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any other active cancers or serious illnesses that are not under control.
Select...
I am currently on high-dose steroids or other drugs that weaken my immune system.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Secondary study objectives
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 and pembrolizumab
2020
Completed Phase 1
~190
TTX-030, budigalimab and mFOLFOX6
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
1,006 Previous Clinical Trials
516,700 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.
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