At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BNT326 (drug), Pumitamig (drug), Itraconazole (drug), Paroxetine (drug)
- How long the study runs
- Study runs about 55 months (dates as stated)
- About the drug or intervention
- BNT326 — drug: Intravenous (IV) infusion · Pumitamig — drug: IV infusion · Itraconazole — drug: Oral administration · Paroxetine — drug: Oral administration
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,438
- Started
- 2025-08-12
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for advanced solid tumor
- • Phase1/Phase2 - 1,438 participants
- • This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced solid tumor
Where?
- • Birmingham - Queen Elizabeth Hospital
- • Cardiff - Velindre Cancer Centre
- • Glasgow - Beatson West of Scotland Cancer Centre
- • Liverpool - The Clatterbridge Cancer Centre
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.
More detail
Both parts (Part 1 and Part 2) will start enrolling study participants independent of each other. In Part 1, participants with histologically or cytologically confirmed advanced solid tumors will receive BNT326 monotherapy in the following cohorts: * Cohort 1A: Cutaneous melanoma (second-line or higher treatment \[2L+\]). * Cohort 1B: Actionable oncogenic alterations (AGA)-negative non-small cell lung cancer (NSCLC) 2L+. * Cohort 1C: Epidermal growth factor receptor mutated (EGFRm) NSCLC 2L+. * Cohort 1D: Rare melanoma (acral/uveal/mucosal melanoma) 2L+. * Cohort 1E: Other advanced solid tumors 2L+. * Cohort 1F (drug-drug interaction \[DDI\] Cohort): Advanced solid tumors. * Cohort 1G: Cervical cancer 2L+. In Part 2, BNT326 will be studied as monotherapy or in combination with other immunotherapeutic agents. The first combination treatment will be BNT326 with BNT327 (also known as pumitamig or PM8002). The following cohorts are planned: * Cohort 2A: BNT326 + pumitamig for cutaneous melanoma 2L+. * Cohort 2B: BNT326 + pumitamig for human epidermal growth factor receptor 2 (HER2)-negative breast cancer 2L+/first line treatment (1L). * Cohort 2C (Optional): BNT326 + pumitamig for cutaneous melanoma first-line or higher treatment (1L+). This cohort may be added if BNT326 + pumitamig for cutaneous melanoma 2L+ is tolerated, and shows signs of efficacy. * Cohort 2D: BNT326 + pumitamig for gastric cancer (GC)/gastroesophageal junction cancer (GEJC) 2L+. * Cohort 2E: BNT326 + pumitamig for colorectal cancer 2L+. * Cohort 2F: BNT326 + pumitamig for cervical cancer 2L+. Participants in Cohorts 1A, 1B, and 1C (dose optimization cohorts) will be randomized to one of two dose levels (DLs) of BNT326 in a 1:1 ratio. An additional, non-randomized dose level arm (DL3) is included in Cohort 1A. During the dose randomization phase of Cohorts 2A and 2B, participants will be randomized 1:1 to one of two combination DLs. During the randomized dose optimization and contribution of components of Cohorts 2D and 2E, participants will be randomized in a 1:1:1 ratio to one of three treatment arms (BNT326 monotherapy at DL2 or BNT326 DL2 with pumitamig \[DL1 or DL2\] combination treatment). An additional, non-randomized dose level arm is included in Cohorts 2D and 2E (BNT326 DL3 in combination with pumitamig DL1 or DL2). No randomization is planned for Cohorts 1D, 1E, 1F, 1G, 2C and 2F. The study will consist of a screening period, a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up period. Study treatment will be continued for up to 24 months or until disease progression, withdrawal of consent, termination of the study by the sponsor, or unacceptable toxicity. If a participant continues to derive clinical benefit at the end of study, study treatment continuation can be considered case-by-case after discussion with the sponsor's medical monitor. For each participant, the treatment and follow-up periods are projected to be completed within \~38 months (Part 1) and \~48 months (Part 2), unless participants are continuing to benefit from treatment per investigator's recommendation and upon sponsor approval.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ regimen that included vemurafenib
- ✓ in cases where it is not part of the SoC
- ✓ due to intolerance
- ✓ or discontinued from pri
What the study is looking for
- ✓Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):
- ✓Aged ≥18 years at the time of giving agreement to take part. Local laws will be followed if the age of consent is older.
- ✓Have cancer that can be measured on scans defined by (standard scan measurements).
- ✓Have Fit enough for normal activity (ECOG 0) or 1.
- ✓Have adequate organ and bone marrow function (as specified in the protocol) within 7 days before...
See the full criteria
Where Is This Study? (12 UK sites)
Queen Elizabeth Hospital
Birmingham B15 2TH, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
The Clatterbridge Cancer Centre
Liverpool L7 8YA, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
Royal Marsden Hospital-London
London SW3 6JJ, United Kingdom
Imperial College London
London W12 0HS, United Kingdom
University College London Hospitals
London W1T 7HA, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie Hospital
Manchester M20 4BX, United Kingdom
Northern Centre for Cancer Care
Newcastle upon Tyne NE7 7DN, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
How to Get in Touch
BioNTech clinical trials patient information
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