T3011 + Pembrolizumab for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: ImmVira Pharma Co. Ltd

No Placebo Group

Trial Summary

What is the purpose of this trial?A Phase 1/2a Open-Label Dose Escalation and Dose Expansion Study of T3011 when Administered Intravenously as a Single Agent and in Combination with Other Therapy in Subjects with Advanced Solid Tumors

Eligibility Criteria

Adults with advanced solid tumors, including specific cancers like NSCLC and colorectal cancer, who have not responded to standard treatments. Participants must be in good health otherwise, with proper organ function and no severe immune deficiencies or active infections. Women of childbearing potential must use effective contraception.

Inclusion Criteria

Life expectancy ≥ 12 weeks

I understand and can follow the study's requirements.

I am 18 years old or older.

+26 more

Exclusion Criteria

Positive serological test of hepatitis B virus (HBV) or hepatitis C virus at Screening

You are pregnant or currently breastfeeding.

I have not received any live vaccines in the last 4 weeks.

+21 more

Participant Groups

The trial is testing T3011, both alone and combined with other therapies for treating various advanced solid tumors. It's an early-phase study that gradually increases the dose to find a safe level before expanding to more patients.

1Treatment groups

Experimental Treatment

Group I: Phase 1Experimental Treatment1 Intervention

T3011 Single Agent Dose Escalation in participants with solid tumors

T3011 is already approved in United States, China for the following indications:

🇺🇸 Approved in United States as MVR-T3011 for:

Recurrent or metastatic head and neck squamous cell cancer (HNSCC) with disease progression after platinum-based chemotherapy and at least one prior line of anti–PD-1/PD-L1 therapy

🇨🇳 Approved in China as MVR-T3011 for: