BNT326 for Cancer

Recruiting at 17 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioNTech SE

Must be taking: PD-1 inhibitors

Must not be taking: Topoisomerase inhibitors

Disqualifiers: Active infection, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 24 months

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, BNT326 (a potential cancer therapy), for individuals with advanced solid tumors that have recurred or spread after other treatments. The study aims to determine the safety and effectiveness of BNT326, both alone and in combination with other immune-targeting drugs. It is open to those with specific advanced cancers, such as melanoma or breast cancer, where no other curative treatment is available. Participants must have a confirmed diagnosis of these conditions and have experienced progression despite previous treatments. As a Phase 1 trial, this research focuses on understanding how BNT326 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking an EGFR TKI (a type of cancer medication), you may continue it until 5 days before starting the trial treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BNT326 has been tested for safety in people with cancer. Early results indicate it is generally well-tolerated, with mostly mild to moderate side effects observed. A previous study temporarily paused to address safety concerns, but treatment resumed after implementing changes.

For the combination of BNT326 and BNT327, research is ongoing, but early findings suggest this combination is also manageable. Side effects, typical for cancer treatments, include tiredness and nausea, but they are usually not severe.

Studies have examined possible interactions when BNT326 is combined with itraconazole or paroxetine. BNT326 with itraconazole requires careful monitoring due to potential interactions, but adjustments have been made to manage any risks. The combination with paroxetine is still under study for safety.

Overall, these treatments are in the early stages of research, with close monitoring for safety and adjustments made as needed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BNT326 and BNT327 because they represent a new approach to cancer treatment. Unlike existing therapies that often target cancer cells broadly, BNT326 and BNT327 are designed to work more specifically, potentially minimizing damage to healthy cells. This precision targeting could lead to fewer side effects and improved effectiveness. Additionally, the combination of these two treatments might enhance their overall impact, offering a novel strategy that could be more effective than current options like chemotherapy or radiation.

What evidence suggests that this trial's treatments could be effective for advanced solid tumors?

Research shows that BNT326, one of the treatments in this trial, has shown promising early results in treating advanced solid tumors when used alone. Some patients have responded positively, and researchers remain hopeful about its potential effectiveness. In this trial, BNT327 serves as another treatment option. When combined with other treatments, it demonstrated an impressive response rate of 85.4% in small cell lung cancer (SCLC), indicating significant improvement in treatment outcomes. BNT327 targets specific proteins that aid tumor growth, effectively blocking their action. Early findings suggest that using BNT326 and BNT327 together, as tested in this trial, could be a powerful approach to tackling difficult-to-treat cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

This trial is for people with advanced malignant tumors, such as skin or lung cancer, that have spread or come back and can't be treated definitively anymore. Participants should have tried other treatments that didn't work.

Inclusion Criteria

I am 18 years old or older.

Have measurable disease defined by RECIST 1.1

My lung cancer is advanced and cannot be cured with surgery or local treatments.

Exclusion Criteria

I have a specific type of liver cancer.

I've had severe side effects from certain cancer drugs like topotecan.

My heart's pumping ability is below 50%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BNT326 as monotherapy or in combination with other immunotherapeutic agents

up to 24 months

Safety Follow-up

Participants are monitored for safety after the last dose of investigational medicinal product

42 days (Part 1) and 90 days (Part 2) post last dose

Efficacy Follow-up

Participants are monitored for efficacy outcomes such as progression-free survival and overall response rate

up to 38 months (Part 1) and 48 months (Part 2)

Long-term Survival Follow-up

Participants are monitored for long-term survival outcomes

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• BNT326
• BNT327

Trial Overview The study tests BNT326 alone (Part 1) and combined with other experimental drugs like BNT327 (Part 2), to find the safest and most effective dose for treating advanced solid tumors.

How Is the Trial Designed?

Group I: Part 2 (Cohort 2B) - BNT326 + BNT327 Experimental Treatment 2 Interventions

Combination therapy of BNT326 (DL1 or DL2) and BNT327 (DL1 or DL2) Optionally, combinations with lower doses of BNT326 and/or BNT327 may be explored.

Group II: Part 2 (Cohort 2A) - BNT326 + BNT327 Experimental Treatment 2 Interventions

Combination therapy of BNT326 (DL1 or DL2) and BNT327 (DL1 or DL2) Optionally, combinations with lower doses of BNT326 and/or BNT327 may be explored.

Group III: Part 1 (Cohort 1F, drug-drug interaction [DDI]) - BNT326 + itraconazole Experimental Treatment 2 Interventions

BNT326 (DL1 or DL2) + itraconazole

Group IV: Part 1 (Cohort 1F, DDI) - BNT326 + paroxetine Experimental Treatment 2 Interventions

BNT326 (DL1 or DL2) + paroxetine

Group V: Part 1 (Cohort 1E) - BNT326 monotherapy Experimental Treatment 1 Intervention

BNT326 (DL2)

Group VI: Part 1 (Cohort 1D) - BNT326 monotherapy Experimental Treatment 1 Intervention

BNT326 (DL2)

Group VII: Part 1 (Cohort 1C) - BNT326 monotherapy Experimental Treatment 1 Intervention

BNT326 (DL1 or DL2)

Group VIII: Part 1 (Cohort 1B) - BNT326 monotherapy Experimental Treatment 1 Intervention

BNT326 (DL1 or DL2)

Group IX: Part 1 (Cohort 1A) - BNT326 monotherapy Experimental Treatment 1 Intervention

BNT326 (dose level \[DL1\] or DL2)

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07111520

Study Details | NCT07111520 | A Clinical Trial to Test if an ... This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS8129

A global phase III, double-blind, randomized trial of ... This Phase III trial will further assess the efficacy and safety of BNT327 in combination with chemo for previously untreated pts with ES-SCLC ...

3. jto.org jto.org/article/S1556-0864(25)00524-6/fulltext

Updated phase II efficacy and safety results of BNT327 ... 332P: Updated phase II efficacy and safety results of BNT327/PM8002 combined with paclitaxel as second-line (2L) therapy in small cell lung cancer (SCLC).

4. targetedonc.com targetedonc.com/view/bnt327-with-chemotherapy-elicits-strong-results-in-es-sclc

BNT327 With Chemotherapy Elicits Strong Results in ES- ... BNT327 combined with chemotherapy showed an overall response rate of 85.4% when used as a first-line treatment for extensive-stage small cell lung cancer.

5. investors.biontech.de investors.biontech.de/news-releases/news-release-details/biontech-present-clinical-and-preclinical-data-across-mrna-and

BioNTech to Present Clinical and Preclinical Data Across ... BNT327 showed a high binding affinity to PD-L1 and VEGF-A and efficient blocking of PD-1/PD-L1 and VEGF-A/VEGFR2 signaling. Anti-tumor activity ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07070232

NCT07070232 | A Clinical Study to Test if an ... This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with ...

7. clinicaltrials.biontech.com clinicaltrials.biontech.com/trials/BNT326-02

A Clinical Trial to Test if an Investigational Combination ... A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non‑small ...

8. mskcc.org mskcc.org/cancer-care/clinical-trials/25-247

A Phase 1-2 Study of BNT326 Alone or With BNT327 in ... Only people with melanoma or breast cancer may be offered the combination of BNT326 and BNT327. Who Can Join. To join this study, there are a few conditions.

9. clinicaltrials.eu clinicaltrials.eu/trial/study-of-bnt326-alone-and-with-bnt327-in-patients-with-advanced-solid-tumors-testing-safety-and-effectiveness-of-new-cancer-treatments/

Study of BNT326 alone and with BNT327 in patients ... The purpose of this research is to determine if BNT326 is safe and potentially helpful when used alone or in combination with other cancer treatments, including ...

10. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-06009

A Clinical Study to Test if an Investigational Treatment ... This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with ...