BNT142 for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid TumorsBNT142 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, BNT142, for safety and how well it works in patients with tumors that have a protein called Claudin 6.

Eligible Conditions
  • Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: at least 48 months subsequent to first dose, are lost to follow-up, or have died

Day 60
Occurrence of dose reductions and discontinuation of BNT142 due to TEAEs
Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, serious, or fatal TEAEs by causal relationship to trial treatment
Day 21
Part 1: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period (Cycle 1, i.e., 21 days after the first dose) during the dose escalation
Month 48
Disease control rate (DCR)
Duration of response (DOR)
Part 1: ORR
Part 2: Objective response rate (ORR)
Day 60
Anti-drug antibodies (ADAs) response
Part 1: PK parameter: Area under the concentration-time curve in the dosing interval (AUC)
Part 1: PK parameter: Clearance (CL)
Part 1: PK parameter: Concentration prior to next dose (Ctrough)
Part 1: PK parameter: Elimination half-life (t½)
Part 1: PK parameter: Maximum observed concentration (Cmax)
Part 1: PK parameter: Minimum observed concentration (Cmin)
Part 1: PK parameter: Time to maximum observed concentration (Tmax)
Part 1: PK parameter: Volume of distribution (Vd)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

BNT142
1 of 1

Experimental Treatment

288 Total Participants · 1 Treatment Group

Primary Treatment: BNT142 · No Placebo Group · Phase 1 & 2

BNT142
Biological
Experimental Group · 1 Intervention: BNT142 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at least 48 months subsequent to first dose, are lost to follow-up, or have died

Who is running the clinical trial?

BioNTech SELead Sponsor
51 Previous Clinical Trials
90,614 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
28 Previous Clinical Trials
7,118 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Preferred tumor sample is CLDN6-positive, assessed by central testing with a validated IHC assay on FFPE neoplastic tissues or fresh tissue if archival material is not available; most recent one preferred for multiple samples.
Your disease must be measurable according to RECIST 1.1 standards or evaluable by GCIG criteria for ovarian tumors.
Patients with advanced/metastatic ovarian (including fallopian tube and peritoneal), non-squamous NSCLC, endometrial or testicular cancer who have no other available treatment likely to confer clinical benefit, or those not eligible for such therapy; as well as patients with NOS tumors including rare cancers and of unknown primary can enroll upon approval by the medical monitor
Your solid tumor is confirmed to be metastatic or irresectable via a pathology report.