Chemotherapy-naïve extensive-stage small cell lung cancer MedDRA version: 21.1 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
BioNTech SE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety profile (Part 1 and 2) and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) (Part 1) of BNT411 in a mixed population of patients with solid tumors.;Secondary Objective: To establish the PK profile (Part 1 and 2) and evaluate the anti-tumor activity of BNT411 according to RECIST 1.1 (Part 2).;Primary end point(s): Part 1 and 2: -Occurrence of dose limiting toxicities (DLTs) within a patient during the DLT evaluation period -Occurrence of treatment-emergent adverse events (TEAEs) within a patient including grade =3, serious, fatal TEAE by relationship -Occurrence of dose reduction and discontinuation of BNT411 within a patient due to treatment emergent adverse events (TEAE) Part 1: -MTD –defined as the highest tolerated dose -Recommended phase 2 dose (RP2D) based on integrated evaluation of safety, tolerability, clinical benefit, Pharmacokinetic (PK), and Pharmacodynamic (PD) data, for all dose levels tested.;Timepoint(s) of evaluation of this end point: Part 1 and 2: DLTs-during the DLT evaluation period (cycle 1: 21 days) TEAE occurrence- from the first dose of BNT411 until the safety follow-up visit. Occurrence of dose reduction and discontinuation of IMP within a patient due to treatment emergent adverse events (TEAEs) will be assessed from the first dose of BNT411 until the safety follow-up visit. Part 1: MTD-at the end of Part 1A and Part 1B. RP2D-at the end of Part 1A and Part 1B. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 1 and 2: -PK parameters (AUC, CL and VD, Cmax, Tmax, Ctrough, and T1/2) Part 2: -Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) is observed as best overall response. -Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) (assessed at least 6 weeks after first dose) is observed as best overall response. -Duration of response (DOR);Timepoint(s) of evaluation of this end point: Part 1 and 2: PK parameters-ongoing basis detailed in the schedule of PK sampling provided in table 1-3 (Part 1A) and table 1-4 (Part 1B) of the protocol. Part 2: ORR- Efficacy will be assessed by on-treatment imaging at Week 6 (+7 days), every 6 weeks (±7 days) for 48 weeks, and every 12 weeks (±7 days) thereafter until disease progression is assessed by the investigator. DCR-at least 6 weeks after first dose until end of safety follow-up visit. DOR-From the time of occurrence from first objective response (CR or PR) to the date of the first occurrence of objective tumor progression or death from any cause, whichever occurs first. | — |
Countries
Germany, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
BioNTech SE
Outcome results
None listed