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Virus Therapy
TAVO412 for Cancer (TAVO412 Trial)
Phase 1
Recruiting
Led By Deborah Doroshow, MD
Research Sponsored by Tavotek Biotherapeutics
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 approximately 12 months
Awards & highlights
Summary
This trial tests TAVO412, a new drug, in patients with advanced cancers that haven't improved with standard treatments. The drug is given through an IV, and researchers will find the best dose and see if it helps shrink the tumors.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including gastric cancer and NSCLC, who have not responded to standard treatments. Participants must be over 18, have measurable disease progression, and an ECOG status of 0 or 1. Women of childbearing potential must test negative for pregnancy and agree to contraception measures.
What is being tested?
TAVO412's safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy are being tested in two parts: first to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D), then further evaluation in new subjects with specific cancers that didn't respond to standard care.
What are the potential side effects?
While the specific side effects of TAVO412 are not listed here as it is a Phase I study primarily assessing safety and tolerability; generally such early-phase trials may involve risks like infusion reactions, fatigue, nausea, blood count changes among others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Tolerability of TAVO412 according to Adverse Events and Number of Participants With Dose Limiting Toxicity (DLT) using National Cancer Institute CTCAE v5.0
Secondary study objectives
Area Under the Serum Concentration-Time Curve From 0-1 (AUC[t0-t1])
Duration of Disease Control (CR, PR, and SD)
Duration of Response (DOR)
+5 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Part 2 CohortsExperimental Treatment1 Intervention
IV infusion of TAVO412
Group II: Part 1 Cohort 5Experimental Treatment1 Intervention
IV infusion of TAVO412
Group III: Part 1 Cohort 4Experimental Treatment1 Intervention
IV infusion of TAVO412
Group IV: Part 1 Cohort 3Experimental Treatment1 Intervention
IV infusion of TAVO412
Group V: Part 1 Cohort 2Experimental Treatment1 Intervention
IV infusion of TAVO412
Group VI: Part 1 Cohort 1Experimental Treatment1 Intervention
IV infusion of TAVO412
Group VII: Part 1 Cohort 0Experimental Treatment1 Intervention
IV infusion of TAVO412
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for advanced or metastatic solid tumors, like those being studied in the TAVO412 trial, include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects.
Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, thereby minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells.
Understanding these mechanisms is crucial for patients as it helps them comprehend how treatments work, potential side effects, and the rationale behind choosing a specific therapy.
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Who is running the clinical trial?
Tavotek BiotherapeuticsLead Sponsor
3 Previous Clinical Trials
92 Total Patients Enrolled
Deborah Doroshow, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have colorectal cancer and have been treated with specific chemotherapy and, if applicable, targeted therapy.I do not have an active infection needing treatment.I haven't had any cancer except for skin cancer in the last 5 years.My kidneys work well enough (creatinine clearance ≥ 30 mL/min).I am 18 years old or older.I haven't received blood products or colony stimulating factors in the last 14 days.I am fully active or can carry out light work.My kidneys are not functioning well (creatinine clearance < 30 mL/min).I have active brain metastases or carcinomatous meningitis.I haven't taken any cancer drugs or experimental medications recently.I still have side effects from previous treatments that are not mild.I have an autoimmune disease that needed treatment.I agree to give extra blood or tissue samples for research.My cancer has come back or hasn't responded to treatment and can't be surgically removed with the aim of curing it.My cancer can be measured and has grown in previously treated areas.I agree to use birth control during and for 60 days after the study.My hepatitis C virus levels are undetectable while on treatment.I've been vaccinated for hepatitis B and only have antibodies showing I was exposed.I have liver issues but can tolerate normal medication doses.I haven't had AIDS-related infections in the last year.I have not had serious heart issues or surgeries in the last 6 months.I have had a condition where my lymphocytes grow abnormally.I am a woman who can have children and have a negative pregnancy test.I agree to use birth control methods for 90 days after my last dose.I have had or currently have another type of cancer besides the one being treated.I have not received a live vaccine in the last 30 days.My TNBC has worsened despite treatment with specific drugs.I am willing to have tumor biopsies before and during treatment.I have a history of cancer.My brain metastases are stable, and I haven't needed steroids in the last 14 days.My cancer has worsened after treatment, or I can't tolerate/choose not to have standard treatment.My CD4+ T-cell count is 350 or higher.I have lung inflammation not caused by an infection or a history of lung tissue disease.I am on antiviral therapy for my active chronic HBV before starting cancer treatment.I have stable Hepatitis C and my cancer treatment won't worsen it.I have gastric or gastroesophageal cancer and have been treated with chemotherapy, immune therapy, and possibly HER2 or other targeted therapy.My NSCLC progressed despite EGFR TKIs, or I've had anti-PD1 and platinum-based treatments for cMET alterations.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Cohort 0
- Group 2: Part 1 Cohort 1
- Group 3: Part 1 Cohort 2
- Group 4: Part 1 Cohort 3
- Group 5: Part 1 Cohort 4
- Group 6: Part 1 Cohort 5
- Group 7: Part 2 Cohorts
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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