TAVO412 for Cancer

(TAVO412 Trial)

Not currently recruiting at 1 trial location

Overseen By Isa Fung

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Tavotek Biotherapeutics

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Active infection, Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment, TAVO412, for individuals with advanced or spreading cancers unresponsive to standard treatments. In the first part, researchers aim to determine a safe dose for those with solid tumors. In the second part, they will examine how TAVO412 affects individuals with specific cancers, such as lung or gastric cancer, whose conditions have worsened despite other treatments. This trial may be suitable for those who have not found success with other cancer treatments. As a Phase 1 trial, this research seeks to understand how TAVO412 functions in people, offering participants the chance to be among the first to receive this new treatment.

Do I need to stop my current medications for the TAVO412 trial?

The trial protocol does not specify if you need to stop your current medications. However, there are specific 'washout' periods (time without taking certain medications) for certain treatments before starting the study drug. It's best to discuss your current medications with the study team to understand any potential interactions.

Is there any evidence suggesting that TAVO412 is likely to be safe for humans?

Research shows that TAVO412 may help treat cancer, particularly in challenging cases. Studies have found it can slow tumor growth in various cancer types, suggesting it might be a useful treatment.

However, TAVO412 remains in the early stages of testing, so limited information exists about its safety in humans. Early trials focus on determining the right dose and assessing tolerability. The primary goal is to ensure safety before progressing to larger studies.

Some studies suggest TAVO412 could be safe and effective, but detailed safety data in humans is not yet available. As this is a Phase 1 trial, researchers are primarily assessing its safety and how people respond to it. This marks the first step in understanding its safety for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TAVO412 because it presents a novel approach to cancer treatment by using an intravenous infusion method that may enhance drug delivery directly to the cancer cells. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, TAVO412 is designed to specifically target cancer cells, potentially reducing side effects and improving patient outcomes. Additionally, TAVO412 might work through a unique mechanism that could lead to faster and more effective treatment responses compared to existing options. This distinct approach offers hope for a more precise and less invasive cancer treatment.

What evidence suggests that TAVO412 might be an effective treatment for cancer?

Research has shown that TAVO412 has produced promising results in early studies. It significantly slowed tumor growth in various cancers, including lung and stomach cancer. The treatment blocks certain proteins that aid tumor growth, making it a hopeful option for hard-to-treat solid tumors. In animal studies, TAVO412 demonstrated strong anti-tumor effects, suggesting it might work similarly in humans. While research in humans continues, these findings offer hope for its potential to treat advanced cancers. Participants in this trial will receive an IV infusion of TAVO412 as part of the study. ^{1 2 4 5 6}

Who Is on the Research Team?

Deborah Doroshow, MD, PhD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have colorectal cancer and have been treated with specific chemotherapy and, if applicable, targeted therapy.

My kidneys work well enough (creatinine clearance ≥ 30 mL/min).

I am fully active or can carry out light work.

Exclusion Criteria

Absolute neutrophil count < 1.5 × 109/L

Hemoglobin < 9 g/dL or < 5.6 mmol/L

I do not have an active infection needing treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 will determine the MTD/RP2D of TAVO412 using a standard 3 + 3 design in subjects with advanced or metastatic solid tumors

Approximately 12 months

Bi-weekly visits for treatment

Cohort Expansion

Part 2 will evaluate the recommended dose and administration schedule determined in Part 1 in a new set of subjects

Approximately 12 months

Bi-weekly visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• TAVO412

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 2 Cohorts Experimental Treatment 1 Intervention

IV infusion of TAVO412

Group II: Part 1 Cohort 5 Experimental Treatment 1 Intervention

IV infusion of TAVO412

Group III: Part 1 Cohort 4 Experimental Treatment 1 Intervention

IV infusion of TAVO412

Group IV: Part 1 Cohort 3 Experimental Treatment 1 Intervention

IV infusion of TAVO412

Group V: Part 1 Cohort 2 Experimental Treatment 1 Intervention

IV infusion of TAVO412

Group VI: Part 1 Cohort 1 Experimental Treatment 1 Intervention

IV infusion of TAVO412

Group VII: Part 1 Cohort 0 Experimental Treatment 1 Intervention

IV infusion of TAVO412

Who Is Running the Clinical Trial?

Tavotek Biotherapeutics

Lead Sponsor

Trials

5

Recruited

190+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06761651

A Study of TAVO412 in Patients with Cancer ... TAVO412 Phase 1 is an open-label, non-randomized, 2-part Phase I study to examine the safety, tolerability, pharmacokinetics/pharmacodynamics, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39995668/

Developing transcriptomic biomarkers for TAVO412 ... TAVO412 demonstrated strong in vivo tumor growth inhibition in 23 cell-line derived xenograft (CDX) models representing diverse cancer types, as ...

3. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1505868/full

Developing transcriptomic biomarkers for TAVO412 ... TAVO412 has demonstrated very promising antitumor activities in animal models including non-small cell lung cancer (NSCLC), gastric cancer (GC), pancreatic ...

4. jitc.bmj.com jitc.bmj.com/content/12/Suppl_2/A900

795 Triple inhibition of EGFR, c-Met and VEGF with ... TAVO412 was successfully discovered and developed for hard-to-treat solid tumors. This drug is expected to be safe and efficacious in cancer patients.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05548634

NCT05548634 | A Study of TAVO412 in Patients with Cancer This is an open-label, non-randomized, Phase I study to determine the safety and tolerability, define the MTD/RP2D, and assess the preliminary ...

6. aacrjournals.org aacrjournals.org/cancerres/article/83/5_Supplement/P2-24-05/716810/Abstract-P2-24-05-TAVO412-A-Novel-Trispecific-cMet

Abstract P2-24-05: TAVO412 - A Novel Trispecific cMet x ... CONCLUSIONS: Tavo412 has the potential activity to be a superior multispecific antibody to treat patients with triple negative breast cancer.