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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 below
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My cancer is confirmed to be advanced and cannot be removed by surgery.
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I am 18 or older and can give my consent.
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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:
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I do not have any other active cancers or serious illnesses that are not under control.
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I am currently on high-dose steroids or other drugs that weaken my immune system.

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
Adverse Events
Secondary study objectives
Disease control rate (DCR)
Duration of response (DoR)
Objective Response Rate (ORR)
+2 more

Trial 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

Budigalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04306900 — Phase 1
Solid Tumors Research Study Groups: Combo 1, Combo 7, Combo 2, Combo 3, Combo 4, Combo 5, Combo 8, Combo 6
Solid Tumors Clinical Trial 2023: Budigalimab Highlights & Side Effects. Trial Name: NCT04306900 — Phase 1
Budigalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04306900 — Phase 1
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