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RecruitingLast updated: 22 December 2025

BNT324-01: This study is for people with advanced, metastatic or relapsed/progressive small cell lung cancer or non-small cell lung cancer to investigate the combination treatment of BNT324 and BNT327A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

BNT324-01

Clinical summary

Summary

This study is testing a new combination of two investigational medicines - BNT324 and BNT327 - to see if they are safe and effective for treating advanced lung cancer, including both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).

The study has two main parts.

Part 1 aims to find the right dose of this drug combination. In this part, participants with relapsed or progressive lung cancer (both SCLC and NSCLC) will receive different dose levels of the drug combination to find two safe options. These doses will be called RP2D (recommended phase 2 dose) and RP2D-1 (a slightly lower dose).

Part 2 will further test the safety and effectiveness of these doses. The two doses will be compared in people with advanced metastatic NSCLC who have not had prior treatment for their advance disease, and people with SCLC what has returned or worsened after previous treatment with chemotherapy (with or without immunotherapy).

Researchers will choose the optimal dose based on safety and howe well it works. More participants may be added to further test this optimal dose.

 

Conditions

This trial is treating people with advanced/metastatic or relapsed/progressive small cell lung cancer or non-small cell lung cancer

Eligibility

Inclusion

  • Aged ≥18 years at the time of giving informed consent.

  • Histological or cytological confirmed unresectable advanced/metastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study.

    • Part 1: Participants with NSCLC and SCLC
    • Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
    • Part 2 Cohort 2: Participants with SCLC, 2L+
    • Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+
    • Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L
    • Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+
    • Part 2 Cohort 6: Participants with NSCLC AGA positive
    • Part 2 Cohort 7: Participants with SCLC, 1L
  • Have measurable disease defined by RECIST version 1.1.
  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have a life expectancy of ≥12 weeks.

Exclusion

  • Prior treatment with B7-H3 targeted therapy.
  • Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line/treatment-naïve cohorts in the advanced/metastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced/metastatic setting.
  • Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment.
  • Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply to all or some participants depending on the cohort.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

BioNTech SE

Scientific Title

A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer

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