Study on Intratumoral T3011 Alone and with Pembrolizumab for Advanced or Metastatic Solid Tumors

Sponsor: ImmVira Pharma Co. Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04370587

Provider View

This clinical trial is testing a new treatment called T3011, given directly into tumors, both by itself and with another drug, pembrolizumab, to see if it is safe and effective for people with advanced or metastatic solid tumors.

Patient Parameters

Program Overview

This study is exploring a new treatment, T3011, which is injected directly into tumors. The trial is in two parts: the first part tests T3011 alone, and the second part tests it in combination with pembrolizumab, a drug given through the vein. The goal is to see if these treatments are safe and can help shrink tumors in people with advanced or metastatic solid tumors.

Description

This clinical trial is divided into two phases. In Phase 1, researchers will test different doses of T3011, given directly into tumors, to find the safest dose. This phase will include about 15 to 30 participants. In Phase 2a, the study will expand to include more participants with specific types of cancer, such as melanoma, head and neck cancer, sarcoma, and skin cancer. The goal is to evaluate the safety and effectiveness of T3011 alone and in combination with pembrolizumab. Participants will be monitored for side effects and how well the treatment works. If the cancer progresses on T3011 alone, participants may be eligible to receive the combination treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have cancer that has worsened after standard treatments or is unlikely to benefit from them.
  • Have specific types of advanced or metastatic cancer, such as melanoma, head and neck cancer, sarcoma, or skin cancer.
  • Have measurable disease according to specific criteria.
  • Have at least one tumor that can be injected with T3011.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of more than 12 weeks.
  • Have adequate organ function based on lab tests.
  • Agree to use effective contraception during the study and for six months after the last dose.
  • Have recovered from previous cancer treatments.
  • Be willing to provide tumor samples for research.
  • Understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Have tumors that cannot be injected.
  • Have tumors near major airways or blood vessels.
  • Have had certain prior treatments, such as other oncolytic viruses or gene therapy.
  • Have a history of severe reactions to similar treatments.
  • Have active infections, including hepatitis B, hepatitis C, or HIV.
  • Have autoimmune diseases or require chronic steroid or immunosuppressive therapy.
  • Be pregnant or breastfeeding.
  • Have a history of organ transplantation.
  • Have active central nervous system metastases or seizure disorders.
  • Have significant heart or lung conditions.
  • Have active COVID-19 infection or other conditions that may interfere with the study.

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