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A clinical study to investigate the efficacy and safety of an investigational combination therapy with BNT324 and BNT327 in patients with advanced lung cancer
EU CTIS ID: 2024-520238-31-01
What this study is testing
Part 1 (Dose Escalation): To determine the recommended phase II dose (RP2D) of BNT324 in combination with BNT327 by assessing the safety and tolerability in participants with advanced lung cancer. Part 2 (Dose Optimization/Signal Seeking): Lead indications Cohort 1 and Cohort 2: To determine the optimal dose of BNT324 in combination with BNT327 by assessing the safety profile and efficacy of the combination therapy in the randomized dose optimization cohorts in the lead cohorts (Cohort 1 treatment naive non-sq non-small cell lung cancer (NSCLC) and Cohort 2 relapsed/progressive small cell lung cancer (SCLC)). Efficacy signal seeking cohorts 3-7: To evaluate the efficacy of BNT324 in combination with BNT327 according to response evaluation criteria in solid tumors (RECIST) v1.1.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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.
You likely can't join if
- 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 study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Turkey
- Korea, Republic of
- Australia
- United Kingdom
- United States
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Turkey; Korea, Republic of; Australia; United Kingdom; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.