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Clinical Trials List

Protocol NumberBNT324-01
NCT Number(ClinicalTrials.gov Identfier)NCT06892548
Active

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

    2026/08/19

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

第 1 部分: 透過評估晚期肺癌參與者的安全性和耐受性來確定 BNT324 併用 BNT327 的 RP2D。 第 2 部分主要適應症群組 1 和群組 2：評估在主要群組（群組 1 為未曾治療的 non-sq NSCLC，群組 2 為復發性/惡化性 SCLC）的隨機分配劑量最佳化群組中併用療法的安全性特性和療效，用以確定 BNT324 併用 BNT327 的最佳劑量。 療效訊號搜尋群組 3-7：依照 RECIST 1.1 評估 BNT324 併用 BNT327 的療效。

Test Drug

靜脈輸注液
溶液用粉劑

Active Ingredient

BNT327
BNT324

Dosage Form

246
145

Dosage

200mg

Endpoints

第 1 部分 依劑量水平：
•DLT 評估期間（第 1 週期，21 天）DLTs 的發生率。
•從第一劑 IMP 到最後一劑 IMP 後 90 天或直到開始新的抗癌治療（以先發生者為準）期間，TEAEs、嚴重 TEAEs、治療相關 TEAEs 和治療相關嚴重 TEAEs 的發生率。
•從第一劑 IMP 到最後一劑 IMP 後 90 天或直到開始新的抗癌治療（以先發生者為準）期間，按劑量水平因 TEAEs 而導致劑量中斷、減少和中止治療的發生率。

第 2 部分主要適應症群組 1 和群組 2：
依群組和治療組：
•從第一劑 IMP 到最後一劑 IMP 後 90 天或直到開始新的抗癌治療（以先發生者為準）期間，TEAEs、嚴重 TEAEs、治療相關 TEAEs 和治療相關嚴重 TEAEs 的發生率。
•從第一劑 IMP 到最後一劑 IMP 後 90 天或直到開始新的抗癌治療（以先發生者為準）期間，因 TEAEs 而導致劑量中斷、減少和中止治療的發生率。
•ORR，定義為觀察到確認的 CR 或 PR 做為最佳整體反應的參與者比例（根據試驗主持人依照 RECIST 1.1 評估）。

第 2 部分 療效訊號搜尋群組 3-7：
依群組：
•ORR，定義為觀察到確認的 CR 或 PR 做為最佳整體反應的參與者比例（根據試驗主持人依照 RECIST 1.1 評估）。

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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