Assessing BT-001 with Pembrolizumab for Advanced Solid Tumors
A Phase I/IIa Study of Intra-tumoral BT-001 (TG6030) Administered Alone and in Combination With Pembrolizumab in Patients With Cutaneous or, Subcutaneous Lesions or Easily Injectable Lymph Nodes of Metastatic/Advanced Solid Tumors.
This study is testing a new treatment called BT-001, alone and with another drug called pembrolizumab, to see if it can help people with advanced solid tumors feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Transgene Industry-sponsored |
| Drugs / interventions | pembrolizumab, radiation, prednisone |
| Locations | 5 sites (Brussels and 4 other locations) |
| Trial ID | NCT04725331 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of BT-001, an oncolytic virus, administered directly into tumors, both alone and in combination with pembrolizumab, an immune checkpoint inhibitor. The study is structured in three parts: the first part focuses on BT-001 as a standalone treatment, while the second part examines its combination with pembrolizumab in specific types of metastatic cancers. The trial aims to determine the optimal dosing and assess the treatment's impact on various advanced solid tumors.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced or metastatic soft tissue sarcoma, Merkel cell carcinoma, melanoma, triple negative breast cancer, or non-small cell lung cancer who have failed standard therapies.
Not a fit: Patients with non-injectable tumors or those who have not failed standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced metastatic cancers that have limited treatment alternatives.
How similar studies have performed: Other studies have shown promise with similar approaches using oncolytic viruses and immune checkpoint inhibitors, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have at least 1 injectable measurable cutaneous, subcutaneous or nodal lesion (direct injection or through the use of ultrasound guidance) not exceeding 50mm in longest diameter and whenever possible 1 distant non-injected measurable lesion. * Provision of a fresh tumor sample of the lesion that will be injected first and, whenever possible, from another lesion that is planned to be injected, at baseline and be willing to supply new tumor samples from a biopsy during treatment. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Have adequate hematological, hepatic and renal functions. * Have histologically confirmed, advanced/metastatic sarcoma (soft tissue and bone), Merkel cell carcinoma, melanoma, triple negative breast cancer or non-small cell lung cancer, with cutaneous or, palpable subcutaneous lesions or easily injectable lymph nodes. * Have failed and/or are intolerant to standard therapeutic options. Exclusion Criteria: * Have had major surgery within 4 weeks of first study drug administration. * Have received prior treatment with a vaccinia oncolytic virus. * Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the start of treatment. * Have received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 28 days prior the first dose of study drugs * Have a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Have a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease * Have an active infection requiring systemic therapy * Have a known history of HIV infection * Is taking an anticoagulant medication that cannot be interrupted prior to IT injections * Have had an allogenic tissue/solid organ transplant or allogenic stem cell or bone marrow transplantation * History of severe exfoliative skin conditions (e.g., eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to BT-001 initiation. * Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE). * Have known active CNS metastases and/or carcinomatous meningitis. * Have a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.n. * Woman of childbearing potential who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment. * Have received or receiving any live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.. * History of myocarditis or congestive heart failure, unstable angina, uncontrolled infection, or myocardial infarction 6 months prior to clinical trial entry. * Interstitial lung disease that is symptomatic and may interfere with the detection or management of suspected drug-related pulmonary toxicity * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment * Have severe hypersensitivity to the active substance or, to any of the excipients of (≥Grade 3) to pembrolizumab. and/or any of its excipients
Where this trial is running
Brussels and 4 other locations
- Clinique Universitaire Saint-Luc — Brussels, Belgium (Recruiting)
- Institut Bergonié — Bordeaux, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Hôpital Saint-Louis AP-HP — Paris, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Transgene EU, Clinical Operations Department
- Email: clinicaltrials@transgene.fr
- Phone: + 33.3.88.27.91.00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.