A study to investigate the safety and efficacy of BNT411 in cancer patients with solid tumor types. The study will also assess the safety and efficacy of BNT411 when taken on its own and in combination with standard chemotherapy treatments in patients with late stage small cell lung cancer who have not taken chemotherapy before.
- Conditions
- Chemotherapy-naïve extensive-stage small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003593-17-DE
- Lead Sponsor
- BioNTech SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
For Part 1A:
• Histologically confirmed solid tumor (cytology is allowed for non small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and pancreatic cancer) that is metastatic or unresectable and for which there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy.
For Part 1B:
• Histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC)(per the Veterans Administration Lung Study Group [VALG] staging system) who received no prior chemotherapy for extensive stage disease.
• Those treated with prior chemo/radiotherapy with curative intent for limited stage small cell lung cancer (LS-SCLC) should be treatment-free for at least 6 months since last chemo/radiotherapy.
• No interstitial lung disease or active, non-infectious pneumonitis.
For Both Part 1A and Part 1B
• Male and female = 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Measurable disease according to RECIST 1.1.
• Adequate hematologic, coagulation, renal and hepatic functions.
Please refer to the protocol for a full list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
• Has received prior systemic therapy with a TLR7 agonist.
• Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of trial treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of trial treatment; any live vaccine within 4 weeks of the start of trial treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment.
• Receives concurrent systemic (oral or intravenous) steroid therapy >10 mg prednisone daily or its equivalent for an underlying condition.
• Receives concurrent strong inhibitors or inducers of the cytochrome P450 enzymes.
• Has had major surgery within the 4 weeks before the first dose of BNT411
• Has ongoing or active infection requiring intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose of trial treatment.
• Has side effects of any prior therapy or procedures for any medical condition not recovered to NCI CTCAE v.5 Grade =1
• Has any contraindication to atezolizumab, carboplatin or etoposide as per USPI or SmPC in Part 1B.
Please refer to the protocol for a full list of exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method