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Clinical Trials List

Protocol NumberBNT324-01
NCT Number(ClinicalTrials.gov Identfier)NCT06892548
Not yet recruiting

2025-09-01 - 2031-08-14

Phase I/II

Recruiting5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Lung Cancer

Objectives

Part 1: Determine the RP2D of BNT324 in combination with BNT327 by assessing safety and tolerability in participants with advanced lung cancer. Part 2: Primary Indication Groups 1 and 2: Evaluate the safety profile and efficacy of this combination therapy in randomized dose-optimized groups (Group 1: treatment-naïve non-sq NSCLC; Group 2: relapsed/advanced SCLC) to determine the optimal dose of BNT324 in combination with BNT327. Efficacy Signal Search Groups 3–7: Evaluate the efficacy of BNT324 in combination with BNT327 according to RECIST 1.1.

Test Drug

Intravenous infusion solution powder

Active Ingredient

BNT327
BNT324

Dosage Form

246
145

Dosage

200mg

Endpoints

Part 1. By Dose Level:

• Incidence of DLTs during the DLT assessment period (Cycle 1, Day 21).

• Incidence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs from the first dose of IMP to 90 days after the last dose of IMP or until the start of new anticancer therapy (whichever occurs first).

• Incidence of dose interruption, reduction, and discontinuation of treatment due to TEAEs, by dose level, from the first dose of IMP to 90 days after the last dose of IMP or until the start of new anticancer therapy (whichever occurs first).

Part 2 Primary Indications Groups 1 and 2: By Group and Treatment Group:

• Incidence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs during the period from the first dose of IMP to 90 days after the last dose of IMP or until the start of new anticancer therapy (whichever occurs first).

• Incidence of dose interruption, reduction, and discontinuation of treatment due to TEAEs during the period from the first dose of IMP to 90 days after the last dose of IMP or until the start of new anticancer therapy (whichever occurs first).

• ORR, defined as the proportion of participants who observed a confirmed CR or PR as the best overall response (assessed by the trial administrator according to RECIST 1.1).

Part 2. Search for therapeutic signals, groups 3-7:

By group:

•ORR, defined as the proportion of participants who observed a confirmed CR or PR as the best overall response (as assessed by the trial administrator according to RECIST 1.1).

Inclution Criteria

Inclusion Criteria:

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 Criteria

Exclusion Criteria:

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.

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    594 participants

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