T3011 + Pembrolizumab for Solid Cancers
Trial Summary
What is the purpose of this trial?
This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must have stopped any previous anticancer therapy at least 21 days before starting the trial treatment.
What data supports the effectiveness of the drug Pembrolizumab in treating solid cancers?
Pembrolizumab has shown effectiveness in treating various solid tumors, including non-small cell lung cancer and advanced cancers with specific genetic features (MSI-H/dMMR), by helping the immune system attack cancer cells. It is approved for use in certain lung cancers and melanoma, indicating its potential benefit in solid cancers.12345
What safety information is available for the treatment T3011 + Pembrolizumab?
Pembrolizumab, also known as Keytruda, has been associated with some side effects, including pneumonitis (lung inflammation) in 1%-5% of patients and a rare risk of type 1 diabetes in 0.2% of cases. Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related side effects can affect organs like the lungs, liver, and thyroid.23567
What makes the drug T3011 + Pembrolizumab unique for treating solid cancers?
Eligibility Criteria
Adults with advanced solid tumors who've had disease progression after standard treatments or are unlikely to benefit from them. They must have a tumor lesion suitable for injection, a life expectancy over 12 weeks, and agree to use contraception. Exclusions include pregnancy, certain allergies, active infections like COVID-19, recent vaccines, immunodeficiencies, organ transplants, some heart conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Dose Escalation
T3011 single agent dose escalation in participants with solid tumors using a 3+3 design to evaluate escalating doses
Phase 2a Part 1
Evaluation of safety, tolerability, and preliminary efficacy of T3011 as a single agent in various cohorts
Phase 2a Part 2
Evaluation of safety, tolerability, and preliminary efficacy of T3011 in combination with pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
- T3011
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
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Who Is Running the Clinical Trial?
ImmVira Pharma Co. Ltd
Lead Sponsor