What side effects are associated with this type of intervention?

Common treatments for advanced or metastatic solid tumors, such as those being studied in the TAVO412 trial, often have a range of side effects. For TAVO412, specific side effects are not detailed, but similar treatments like buparlisib can cause fatigue, nausea, hyperglycemia, decreased appetite, and diarrhea. Durvalumab is associated with pneumonia, diarrhea, pneumonitis, rash, and pruritus. Paclitaxel can lead to neuropathy and myelosuppression, while PLD is known for causing less severe side effects like mucositis and hand-foot syndrome. Trastuzumab's side effects include chills, fever, nausea, vomiting, and potential cardiac dysfunction. These side effects highlight the importance of monitoring and managing adverse reactions in patients undergoing treatment for advanced cancers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of advanced or metastatic solid tumors. Pembrolizumab, an anti-PD-1 therapy, is approved for various cancers, including melanoma and non-small cell lung cancer (NSCLC). Ipilimumab, an anti-CTLA-4 therapy, is approved for unresectable or metastatic melanoma. Additionally, combination therapies such as nivolumab plus ipilimumab have shown efficacy in treating advanced melanoma. These treatments, like TAVO412, target advanced stages of cancer and aim to improve patient outcomes through immunotherapy and targeted approaches.

What other types of research exist?

Promising novel alternatives to TAVO412 for cancer patients in 2024 include: <ol> <li>Bevacizumab - Active against various cancers including renal cancer and mesothelioma.</li> <li></li> </ol> Sorafenib, Sunitinib, and Temsirolimus - Targeting renal cancer and other malignancies. 3. Pembrolizumab and Nivolumab - Immune checkpoint inhibitors used in glioblastoma and other cancers. 4. Regorafenib - Effective in colorectal and gastric cancers. 5. Apatinib - VEGFR-2 inhibitor for advanced gastric cancer. 6. Dabrafenib and Trametinib - Targeting BRAFV600E mutations in melanoma and other cancers.

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Virus Therapy

TAVO412 for Cancer (TAVO412 Trial)

Phase 1

Waitlist Available

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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Do I qualify?Apply below to find out

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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