TAVO412 for Cancer

(TAVO412 Trial)

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

50 Participants Needed

Trial Summary

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.

How does the drug TAVO412 differ from other cancer treatments?

TAVO412 is unique because it may involve the use of vascular disrupting agents (VDAs) like OXi4503, which can make tumors that don't respond to immune therapy become sensitive to it. This approach is different from standard treatments as it targets the blood vessels within tumors to enhance the effectiveness of immune checkpoint inhibitors. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Deborah Doroshow, MD, PhD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I clinical and pharmacokinetic evaluation of the vascular-disrupting agent OXi4503 in patients with advanced solid tumors. [2012]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Trabectedin : a review of its use in the management of soft tissue sarcoma and ovarian cancer. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical utility of trabectedin for the treatment of ovarian cancer: current evidence. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Trabectedin for the therapy of ovarian cancer. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Tumors Resistant to Checkpoint Inhibitors Can Become Sensitive after Treatment with Vascular Disrupting Agents. [2021]