Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

Conditions

• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BNT116 — BIOLOGICAL
  Intravenous injection
• Cemiplimab — BIOLOGICAL
  Intravenous infusion
• Docetaxel — DRUG
  Intravenous infusion
• Carboplatin — DRUG
  Intravenous infusion
• Paclitaxel — DRUG
  Intravenous infusion
• BNT316 — BIOLOGICAL
  Intravenous infusion
• anti-B7-H3 antibody conjugated to topoisomerase I inhibitor — BIOLOGICAL
  Intravenous infusion
• anti-HER3 antibody conjugated to topoisomerase I inhibitor — BIOLOGICAL
  Intravenous infusion
• Bispecific antibody for PD-L1 and VEGF-A — BIOLOGICAL
  Intravenous infusion
• Osimertinib — BIOLOGICAL
  Oral
• ALK-inhibitor or RET-inhibitor — BIOLOGICAL
  Oral

Study Details

This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC). The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.

Key Dates

Start date

Jun 17, 2022

Status verified

Apr 2026

Primary completion

Feb 28, 2030

Completion

Nov 30, 2031

Study Design

Enrollment

320 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1A - BNT116 Monotherapy
• Experimental: Cohort 1B - BNT116 Monotherapy
• Experimental: Cohort 2 - BNT116 + Cemiplimab (PD-1/PD-L1 Inhibitor Refractory/Relapsed Participants)
• Experimental: Cohort 3 - BNT116 + Docetaxel
• Experimental: Cohort 4 - BNT116 + Cemiplimab (Frail Participants)
• Experimental: Cohort 5 - BNT116 + Cemiplimab (After Concurrent Chemoradiotherapy [CRT])
• Experimental: Cohort 6 - BNT116 + Cemiplimab + Carboplatin + Paclitaxel
  BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab
• Experimental: Cohort 7 - BNT116 + BNT316
  Dose finding for the combination of BNT116 with BNT316 (CTLA4 antibody) with dose escalation of BNT316
• Experimental: Cohort 8: BNT116 + Anti-B7-H3 Antibody Conjugated to Topoisomerase I Inhibitor
  Dose finding for the combination of BNT116 with an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor
• Experimental: Cohort 9: BNT116 + Anti-HER3 Antibody Conjugated to Topoisomerase I Inhibitor
  Dose confirmation for the combination of BNT116 with an anti-HER3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-HER3 antibody conjugated to a topoisomerase I inhibitor
• Experimental: Cohort 10: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (Frail Participants)
  Dose confirmation for BNT116 in combination with a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) will be established.
• Experimental: Cohort 11: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (After Concurrent CRT)
  Dose confirmation for BNT116 in combination with a bispecific antibody for PD-L1 and VEGF-A will be established in participants after concurrent CRT.
• Experimental: Cohort EGFR : BNT116 + osimertinib
  Dose confirmation for BNT116 in combination with ongoing osimertinib therapy. Treatment with osimertinib is standard of care. Cohort will enroll only at selected sites in the US.
• Experimental: Cohort ALK/RET: BNT116 + ALK TKI or RET TKI
  Dose confirmation for BNT116 in combination with either ongoing ALK-inhibitor or ongoing RET-inhibitor therapy. Treatment with ALK TKI or RET TKI is standard of care. Cohort will enroll only at selected sites in the US.

Primary Outcome Measure

Cohorts 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, EGFR and ALK/RET: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period [ Time Frame: From first dose of IMP up to 21 days ]

Central Contacts

• BioNTech clinical trials patient information
  +49 6131 9084
  [email protected]

Locations (5)

Find similar trials in Lexington, KY

Related Studies

• Harvesting Cells for Experimental Cancer Treatments
  Enrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
• Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
  PHASE3 · Recruiting · University of Texas Southwestern Medical Center · La Jolla, California
• Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland