Advanced Solid TumorPhase 1/2NCT06750185
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
A Phase 1/2 study testing BNT317 DL1, BNT317 DL2 and BNT317 DL3 in people with Advanced Solid Tumor, run by BioNTech SE at 11 sites in 2 countries.
Trial summary
This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BNT317 DL1, BNT317 DL2 and BNT317 DL3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 13 Jan 2025to Apr 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically or cytologically confirmed advanced tumors, who have failed standard therapy, or for whom no standard treatment option is available, or for whom standard therapy is not appropriate.
- Have at least one measurable lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system [CNS] metastasis should not be considered as a measurable lesion).
- Adequate hematologic and organ function, as defined in the protocol.
- Have had an adequate treatment washout period before randomization/enrollment, as defined in the protocol.
- Part B1 only: Histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic clear cell RCC (including those with sarcomatoid features).
- Part B1 2L subgroup only: Had disease progression during or after one line of prior anticancer therapy for recurrent/metastatic disease which must have included immune checkpoint inhibitor and/or tyrosine kinase inhibitor (TKI).
Show all 25Show fewer
- Part B1 3L+ subgroup only: Had disease progression during or after two or more lines of prior anticancer therapy for recurrent/metastatic disease defined as the following:
- Prior treatment should also contain one or two of the following treatments:
- One line of immune checkpoint inhibitor.
- At least one line of a TKI.
- Part B2 only: Undergoing SoC treatment or is willing to start SoC treatment for 2L+ HER2-negative GC/GEJC in accordance with the product label and local treatment guidelines.
- Part B2 only: Histologically and/or cytologically documented metastatic adenocarcinoma and squamous carcinoma of GC/GEJC. (Note: Esophageal squamous cell carcinoma is excluded).
- Part B2 2L subgroup only: Had disease progression during or after one prior line of anticancer therapy for recurrent/metastatic disease which must have included a fluoropyrimidine analogue and a platinum agent with or without programmed death (PD)-1/ PD-ligand 1 (PD-L1). The total of cytotoxic containing regimens must be limited to maximum of 1 line for the recurrent/metastatic setting.
- Part B2 3L+ subgroup only: Had disease progression during or after two or more lines of prior anticancer therapy for recurrent/metastatic disease defined as the following:
- Prior treatment must include one line of treatment containing a fluoropyrimidine analogue and a platinum agent, unless the participant is not a candidate in the opinion of the treating physician.
- Prior treatment should also contain one or two of the following treatments:
- One line of a cytotoxic agent per local SoC.
- One line of a non-cytotoxic agent alone or in combination with cytotoxic chemotherapy.
- Treatment with cytotoxic agents at the recurrent/metastatic setting must be limited to a maximum of two lines.
- Part B2 only: Have a helicobacter pylori status result determined and documented prior to trial screening as part of SoC.
- Part B3 only: Undergoing SoC treatment or is willing to start SoC treatment for 2L+ AGA-negative NSCLC in accordance with the product label and local treatment guidelines.
- Part B3 only: Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous NSCLC.
- Part B3 only: Have no actionable genomic alterations, such as Epidermal Growth Factor Receptor mutations, anaplastic lymphoma kinase rearrangements, or other genomic alterations for which targeted molecular therapies are available. For enrolled participants with predominantly squamous histology tumors, molecular testing will not be required in cases where it is not part of the SoC.
- Part B3 only: Have experienced relapse or progression during or after treatment with standard systemic therapy including platinum-based chemotherapy and/or immune checkpoint inhibitor in the advanced/metastatic setting or discontinued from prior therapy due to intolerance.
- Part B3 only: Participants must have received 1 to 3 or more lines of systemic treatment, which can include anti-PD-1/PD-L1 therapy (if PD-L1 positive), chemotherapy, and anti-angiogenic agents. These treatments may be administered concurrently or sequentially. Prior chemotherapy must be limited to 2 lines or less.
Who cannot join
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Any prior treatment which inhibits cluster of differentiation 39.
- Vaccination with live attenuated vaccine(s) within 4 weeks prior to the first dose of IMP.
- Any investigational product within 4 weeks or 5 half lives (if the half life of the other investigational product is known), whichever is longer, before the first dose of IMP in this study or ongoing participation in the active treatment phase of another interventional clinical study.
- Systemic cytotoxic chemotherapy, immunotherapy within 3 weeks or five half-lives of the chemotherapy (whichever is shorter) prior to the first dose of IMP.
- Radiation therapy (chest, brain or internal organs) within 4 weeks prior to the first dose of IMP.
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- Palliative radiotherapy to metastasis within 2 weeks prior to the first dose of IMP.
- Systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 2 weeks prior to the first dose of IMP. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) is allowed.
- Have any of the following CNS metastases:
- Untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
- Treated CNS metastases who are not neurologically stable or on steroids or anticonvulsants within 2 weeks before initiating IMP of this study.
- Brain metastases treated with radiotherapy that are not confirmed stable by magnetic resonance imaging or contrast-enhanced computer tomography 4 weeks after radiotherapy.
- Participants with known leptomeningeal metastases.
- Have uncontrolled hypertension or poorly controlled diabetes as specified in the protocol.
- Have a history of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Have a history of serious Grade ≥3 immune-related adverse events (irAEs) or irAEs that led to discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 irAEs that did not lead to discontinuation of a prior immunotherapy may be included at the discretion of the investigator. If required by the investigator, after consultation with the sponsor.
- Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States7 sites, 5 recruiting
- Recruiting
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
- Recruiting
Rhode Island Hospital
East Providence, Rhode Island, 02903
- Active, not recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
Carolina BioOncology Institute, LLC
Huntersville, North Carolina, 28078
- Recruiting
Norton Cancer Institute PARENT
Louisville, Kentucky, 40202
- Active, not recruiting
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, 78229
Australia4 sites
- Active, not recruiting
Cancer Research SA
Adelaide, 5000
- Active, not recruiting
Monash Medical Centre Clayton
Clayton, 3168
- Active, not recruiting
Scientia Clinical Research
Randwick, 2031
- Active, not recruiting
Tasman Oncology Research Ltd
Southport, Queensland, 4215
About this study
Official title: A Phase I/II, First-in-human, Open-label Trial of the Safety, Efficacy, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Participants With Advanced Solid Tumors
This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.
Read the detailed description
The study will consist of four parts, Part A, Part B1, Part B2 and Part B3.
Part A will be a dose escalation part to investigate the safety and tolerability of BNT317 in participants with advanced solid tumors and may enroll additional participants with advanced solid tumors to specific dose levels (DLs), based on the emerging safety, PK, and pharmacodynamic data. Part A will evaluate up to six DLs of BNT317 monotherapy.
Part B will include dose optimization and dose expansion components to further investigate the safety and tolerability of BNT317 and to investigate preliminary antitumor activity, i.e.:
- Part B1 will further evaluate BNT317 monotherapy in participants with second-line of therapy or higher (2L+) clear cell renal cell carcinoma (ccRCC). Participants will be randomized 1:1 into two dose groups which will evaluate two DLs (as selected from Part A).
- Part B2 will further evaluate BNT317 when added to standard of care (SoC) treatment in participants with 2L+ human epidermal growth factor receptor 2 (HER2)-negative gastric cancer (GC)/gastroesophageal junction cancer (GEJC). Participants will be randomized 1:1 into two dose groups which will evaluate two DLs (as selected from Part A).
- Part B3 will further evaluate BNT317 when added to SoC treatment in participants with 2L+ actionable genomic alteration (AGA)-negative non-small cell lung cancer (NSCLC) at the higher of the two BNT317 dose groups being investigated in Parts B1 and B2.
Participants may receive investigational medicinal product (IMP) for up to 2 years or until they experience disease progression, unacceptable toxicities, withdrawal of consent, study discontinuation or investigator decision. The total duration of the study for a single participant may be up to 2 years, plus follow-up until the last participant has completed 1 year of survival follow-up (excluding screening).
In Part A (dose escalation), an accelerated titration design for DL1 and a Bayesian Optimal Interval (BOIN) design for dose groups DL2 and above will be used to evaluate dose limiting toxicities (DLTs).
Additional dosing schedules and/or intermediate or higher DLs may be evaluated based on the available safety, antitumor activity, PK, and pharmacodynamic data.
- Conditions
- Advanced Solid Tumor
- Being tested
- BNT317 DL1, BNT317 DL2, BNT317 DL3, BNT317 DL4, BNT317 DL5
- Keywords
- Malignant solid tumors, Immunotherapy, Standard of care (SoC) treatment, Clear cell renal cell carcinoma (ccRCC), Human epidermal growth factor receptor 2 (HER2) negative, Gastric cancer (GGC), Gastroesophageal junction cancer (GEJC), Non-small cell lung cancer (NSCLC), Actionable genomic alteration (AGA)- negative
- Medical subject headings
- Carcinoma, Renal Cell, Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT317 DL1Biological
Intravenous infusion
BNT317 DL2Biological
Intravenous infusion
BNT317 DL3Biological
Intravenous infusion
BNT317 DL4Biological
Intravenous infusion
BNT317 DL5Biological
Intravenous infusion
BNT317 DL6Biological
Intravenous infusion
BNT317 selected DLABiological
Intravenous infusion
BNT317 selected DLBBiological
Intravenous infusion
SoC chemotherapy 1Drug
Intravenous infusion
SoC chemotherapy 2Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A - BNT317 DL1 | Experimental | BNT317 monotherapy Receives: Biological: BNT317 DL1 |
| Part A - BNT317 DL2 | Experimental | BNT317 monotherapy Receives: Biological: BNT317 DL2 |
| Part A - BNT317 DL3 | Experimental | BNT317 monotherapy Receives: Biological: BNT317 DL3 |
| Part A - BNT317 DL4 | Experimental | BNT317 monotherapy Receives: Biological: BNT317 DL4 |
| Part A - BNT317 DL5 | Experimental | BNT317 monotherapy Receives: Biological: BNT317 DL5 |
| Part A - BNT317 DL6 (optional) | Experimental | BNT317 monotherapy Receives: Biological: BNT317 DL6 |
| Part B1 - BNT317 selected DLA | Experimental | BNT317 monotherapy, DL as selected from Part A. Receives: Biological: BNT317 selected DLA |
| Part B1 - BNT317 selected DLB | Experimental | BNT317 monotherapy, DL as selected from Part A. Receives: Biological: BNT317 selected DLB |
| Part B2 - BNT317 selected DLA plus SoC chemotherapy 1 | Experimental | BNT317 combination therapy, DL as selected from Part A. Receives: Biological: BNT317 selected DLA; Drug: SoC chemotherapy 1 |
| Part B2 - BNT317 selected DLB plus SoC chemotherapy 1 | Experimental | BNT317 combination therapy, DL as selected from Part A. Receives: Biological: BNT317 selected DLB; Drug: SoC chemotherapy 1 |
| Part B3 - BNT317 selected DLB plus SoC chemotherapy 2 | Experimental | BNT317 combination therapy, DL as selected from Parts B1 and B2. Receives: Biological: BNT317 selected DLB; Drug: SoC chemotherapy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - Occurrence of DLTs
Per dose group. During the DLT observation period.
Measured: Up to 28 days after initiating BNT317 administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)
All parts - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related adverse events (TRAEs), treatment-related Grade ≥3 TEAEs, and treatment-related SAEs
Per dose group.
Measured: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - Occurrence of dose interruption, reductions, and discontinuation of BNT317 due to TEAEs
Per dose group.
Measured: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Parts B1, B2 & B3: Objective Response Rate (ORR)
Per dose group. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator's assessment) is observed as best overall response.
Measured: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Secondary outcomes (10)
Part A - ORR
Per dose group. Defined as the proportion of participants in whom a confirmed CR or PR (per RECIST v1.1 based on the investigator's assessment) is observed as best overall response.
Measured: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - Duration of Response
Per dose group. Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - Disease Control Rate
Per dose group. Defined as the proportion of participants in whom a confirmed CR or PR or stable disease (per RECIST v1.1) is observed as best overall response per investigator's assessment.
Measured: From at least 6 weeks (±7 days) after the first BNT317 dose up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All Parts - PK assessment: The maximum (peak) serum concentration (Cmax) of BNT317
Per dose group. If data permits.
Measured: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - PK assessment: Time to reach maximum (peak) serum concentration (Tmax) of BNT317
Per dose group. If data permits.
Measured: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - PK assessment: Elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time-curve (t1/2) of BNT317
Per dose group. If data permits.
Measured: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - PK assessment: The area under the curve (AUC) from time zero to infinity (AUCinf) of BNT317
Per dose group. If data permits.
Measured: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - PK assessment: The AUC from time zero to the end of the dosing period of BNT317
Per dose group. If data permits.
Measured: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - Anti-drug antibody (ADA) prevalence
Per dose group. The proportion of participants who are ADA positive (either baseline or post-baseline). If data permits.
Measured: From first dose of BNT317 up to 31 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - ADA incidence
Per dose group. The proportion of participants having treatment-emergent ADA). If data permits.
Measured: From first dose of BNT317 up to 31 days after last dose of IMP or until a new anticancer therapy is initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start13 Jan 2025
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750185
- Sponsor's protocol ID
- BNT317-01
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, First-in-human, Open-label Trial of the Safety, Efficacy, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06750185
- Acronym / sponsor ID
- BNT317-01
- Conditions
- Advanced Solid Tumor
- Keywords
- Malignant solid tumors, Immunotherapy, Standard of care (SoC) treatment, Clear cell renal cell carcinoma (ccRCC), Human epidermal growth factor receptor 2 (HER2) negative, Gastric cancer (GGC), Gastroesophageal junction cancer (GEJC), Non-small cell lung cancer (NSCLC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.
Detailed description
The study will consist of four parts, Part A, Part B1, Part B2 and Part B3.
Part A will be a dose escalation part to investigate the safety and tolerability of BNT317 in participants with advanced solid tumors and may enroll additional participants with advanced solid tumors to specific dose levels (DLs), based on the emerging safety, PK, and pharmacodynamic data. Part A will evaluate up to six DLs of BNT317 monotherapy.
Part B will include dose optimization and dose expansion components to further investigate the safety and tolerability of BNT317 and to investigate preliminary antitumor activity, i.e.:
- Part B1 will further evaluate BNT317 monotherapy in participants with second-line of therapy or higher (2L+) clear cell renal cell carcinoma (ccRCC). Participants will be randomized 1:1 into two dose groups which will evaluate two DLs (as selected from Part A).
- Part B2 will further evaluate BNT317 when added to standard of care (SoC) treatment in participants with 2L+ human epidermal growth factor receptor 2 (HER2)-negative gastric cancer (GC)/gastroesophageal junction cancer (GEJC). Participants will be randomized 1:1 into two dose groups which will evaluate two DLs (as selected from Part A).
- Part B3 will further evaluate BNT317 when added to SoC treatment in participants with 2L+ actionable genomic alteration (AGA)-negative non-small cell lung cancer (NSCLC) at the higher of the two BNT317 dose groups being investigated in Parts B1 and B2.
Participants may receive investigational medicinal product (IMP) for up to 2 years or until they experience disease progression, unacceptable toxicities, withdrawal of consent, study discontinuation or investigator decision. The total duration of the study for a single participant may be up to 2 years, plus follow-up until the last participant has completed 1 year of survival follow-up (excluding screening).
In Part A (dose escalation), an accelerated titration design for DL1 and a Bayesian Optimal Interval (BOIN) design for dose groups DL2 and above will be used to evaluate dose limiting toxicities (DLTs).
Additional dosing schedules and/or intermediate or higher DLs may be evaluated based on the available safety, antitumor activity, PK, and pharmacodynamic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A - BNT317 DL1 | Experimental | Biological: BNT317 DL1BNT317 monotherapy |
| Part A - BNT317 DL2 | Experimental | Biological: BNT317 DL2BNT317 monotherapy |
| Part A - BNT317 DL3 | Experimental | Biological: BNT317 DL3BNT317 monotherapy |
| Part A - BNT317 DL4 | Experimental | Biological: BNT317 DL4BNT317 monotherapy |
| Part A - BNT317 DL5 | Experimental | Biological: BNT317 DL5BNT317 monotherapy |
| Part A - BNT317 DL6 (optional) | Experimental | Biological: BNT317 DL6BNT317 monotherapy |
| Part B1 - BNT317 selected DLA | Experimental | Biological: BNT317 selected DLABNT317 monotherapy, DL as selected from Part A. |
| Part B1 - BNT317 selected DLB | Experimental | Biological: BNT317 selected DLBBNT317 monotherapy, DL as selected from Part A. |
| Part B2 - BNT317 selected DLA plus SoC chemotherapy 1 | Experimental | Biological: BNT317 selected DLA, Drug: SoC chemotherapy 1BNT317 combination therapy, DL as selected from Part A. |
| Part B2 - BNT317 selected DLB plus SoC chemotherapy 1 | Experimental | Biological: BNT317 selected DLB, Drug: SoC chemotherapy 1BNT317 combination therapy, DL as selected from Part A. |
| Part B3 - BNT317 selected DLB plus SoC chemotherapy 2 | Experimental | Biological: BNT317 selected DLB, Drug: SoC chemotherapy 2BNT317 combination therapy, DL as selected from Parts B1 and B2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Have histologically or cytologically confirmed advanced tumors, who have failed standard therapy, or for whom no standard treatment option is available, or for whom standard therapy is not appropriate.
- Have at least one measurable lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system [CNS] metastasis should not be considered as a measurable lesion).
- Adequate hematologic and organ function, as defined in the protocol.
- Have had an adequate treatment washout period before randomization/enrollment, as defined in the protocol.
- Part B1 only: Histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic clear cell RCC (including those with sarcomatoid features).
Key exclusion criteria (18 listed)
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Have any of the following CNS metastases:
- Have uncontrolled hypertension or poorly controlled diabetes as specified in the protocol.
- Have a history of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Have a history of serious Grade ≥3 immune-related adverse events (irAEs) or irAEs that led to discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 irAEs that did not lead to discontinuation of a prior immunotherapy may be included at the discretion of the investigator. If required by the investigator, after consultation with the sponsor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT317 DL1Intravenous infusion | Biological | Part A - BNT317 DL1 |
| BNT317 DL2Intravenous infusion | Biological | Part A - BNT317 DL2 |
| BNT317 DL3Intravenous infusion | Biological | Part A - BNT317 DL3 |
| BNT317 DL4Intravenous infusion | Biological | Part A - BNT317 DL4 |
| BNT317 DL5Intravenous infusion | Biological | Part A - BNT317 DL5 |
| BNT317 DL6Intravenous infusion | Biological | Part A - BNT317 DL6 (optional) |
| BNT317 selected DLAIntravenous infusion | Biological | Part B1 - BNT317 selected DLA, Part B2 - BNT317 selected DLA plus SoC chemotherapy 1 |
| BNT317 selected DLBIntravenous infusion | Biological | Part B1 - BNT317 selected DLB, Part B2 - BNT317 selected DLB plus SoC chemotherapy 1, Part B3 - BNT317 selected DLB plus SoC chemotherapy 2 |
| SoC chemotherapy 1Intravenous infusion | Drug | Part B2 - BNT317 selected DLA plus SoC chemotherapy 1, Part B2 - BNT317 selected DLB plus SoC chemotherapy 1 |
| SoC chemotherapy 2Intravenous infusion | Drug | Part B3 - BNT317 selected DLB plus SoC chemotherapy 2 |
Primary outcome
Part A - Occurrence of DLTs
Time frame: Up to 28 days after initiating BNT317 administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)
Per dose group. During the DLT observation period.
All parts - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related adverse events (TRAEs), treatment-related Grade ≥3 TEAEs, and treatment-related SAEs
Time frame: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Per dose group.
All parts - Occurrence of dose interruption, reductions, and discontinuation of BNT317 due to TEAEs
Time frame: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Per dose group.
Parts B1, B2 & B3: Objective Response Rate (ORR)
Time frame: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Per dose group. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator's assessment) is observed as best overall response.
10 secondary outcomes
Part A - ORR
Time frame: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - Duration of Response
Time frame: From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - Disease Control Rate
Time frame: From at least 6 weeks (±7 days) after the first BNT317 dose up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All Parts - PK assessment: The maximum (peak) serum concentration (Cmax) of BNT317
Time frame: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - PK assessment: Time to reach maximum (peak) serum concentration (Tmax) of BNT317
Time frame: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - PK assessment: Elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time-curve (t1/2) of BNT317
Time frame: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - PK assessment: The area under the curve (AUC) from time zero to infinity (AUCinf) of BNT317
Time frame: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - PK assessment: The AUC from time zero to the end of the dosing period of BNT317
Time frame: From pre-dose Cycle 1 to pre-dose Cycle 4 (each cycle is 14 days)
All parts - Anti-drug antibody (ADA) prevalence
Time frame: From first dose of BNT317 up to 31 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - ADA incidence
Time frame: From first dose of BNT317 up to 31 days after last dose of IMP or until a new anticancer therapy is initiated
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BioNTech Responsible Person study director
BioNTech SE
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BNT317 DL1, BNT317 DL2 and BNT317 DL3 in people with Advanced Solid Tumor, run by BioNTech SE at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A - Occurrence of DLTs (time frame: Up to 28 days after initiating BNT317 administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.