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New treatment option for Advanced Solid Tumor
Official title A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT07070232
What this study is testing
What is BNT326?
BNT326 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key (applicable to all participants and all parts unless otherwise specified):
- Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older.
- Have histologic or cytologic documented advanced disease, either at relapse or upon diagnosis of metastatic disease. This requirement may be...
- Have measurable disease defined by RECIST v1.1.
- All participants must provide a tumor tissue sample (Formalin-fixed paraffin-embedded [FFPE] slides) from archival tissue. The archival tissue can be...
You likely can't join if
- (applicable to all participants and all parts unless otherwise specified):
- Have a history of intolerance to treatment with a topoisomerase I inhibitor or intolerance to an ADC that consists of a topoisomerase I inhibitor...
- Have an uncontrolled concomitant or intercurrent illness that contra-indicates study participation, limits compliance with study procedures or...
- Bleeding diathesis or active hemorrhage,
- Active infection,
- Child-Pugh class B or C cirrhosis,
See the full eligibility criteria
Who can join
- Key (applicable to all participants and all parts unless otherwise specified):
- Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older.
- Have histologic or cytologic documented advanced disease, either at relapse or upon diagnosis of metastatic disease. This requirement may be considered met when advanced disease derives from unequivocal progression of a...
- Have measurable disease defined by RECIST v1.1.
- All participants must provide a tumor tissue sample (Formalin-fixed paraffin-embedded [FFPE] slides) from archival tissue. The archival tissue can be an FFPE block or freshly cut slides derived from the advanced setting...
- Have ECOG performance status of 0 or 1.
- Have adequate organ and bone marrow function (as specified in the protocol) within 7 days before randomization/enrollment.
- Cohort 1A:
- Have histologically or cytologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma not amenable to local therapy.
- Participants must have previously received a PD-1 or PD-L1 inhibitor, and, for participants with human gene that encodes a protein called B-Raf (BRAF) gene mutant melanoma, a prior treatment regimen that included...
- Cohort 1B and 1C: Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous NSCLC.
- Cohort 1B:
- Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase rearrangements, or other genomic alterations for which targeted molecular therapies are available. For enrolled participants...
- 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...
- Participants must have received 1 to 3 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...
- Cohort 1C:
- Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).
- Participants must have received one or two prior lines of systemic therapy for advanced and/or metastatic disease, which must include treatment with an approved EGFR Tyrosine Kinase Inhibitors (TKI), with at least one...
- Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.
- Prior chemotherapy and amivantamab are permitted only if administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first line) treatment for advanced/metastatic disease...
- Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance.
- Cohort 1D:
- Have histologically or cytologically confirmed diagnosis of unresectable or metastatic acral/uveal/mucosal melanoma not amenable to local therapy.
- Participants must have:
- Previously been treated with a PD-1 or PD-L1 inhibitor, if clinically indicated and available per local SoC, and/or
- For participants with Human Leukocyte Antigen Alleles (HLA-A)\ 02:01 serotype-positive disease (only applicable for uveal melanoma), previously been treated with tebentafusp-tebn if clinically indicated and available...
- Experienced progression during or after the previous treatment or discontinued from prior therapy due to intolerance.
- Cohorts 1E and 1F (DDI):
- Have histologically or cytologically confirmed diagnosis of unresectable or metastatic advanced solid tumor not amenable to ablative or curative approach including, but not limited to:
- Cholangiocarcinoma, including tumors of the intra- and extrahepatic biliary tract and gallbladder
- Hepatocellular carcinoma (HCC).
- Renal cell carcinoma
- Endometrial carcinoma, excluding those classified as true sarcomas
- Pancreatic ductal adenocarcinoma (PDAC) (see below other related inclusion criterion)
- Neuroendocrine tumor of pancreatic, gastrointestinal, lung, and thymus that is well differentiated, Grade 1 to 3.
- NSCLC (Cohort 1F only)
- Have experienced disease progression on at least one and no more than three lines of prior therapy or, for Cohort 1E only, discontinued from prior therapy due to intolerance.
- (For participants with PDAC only) Have received one or two lines of systemic therapy for metastatic tumors, and have experienced progression or intolerance to the treatment during or following therapy.
- Cohort 2A: Have histologically or cytologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma not amenable to local therapy.
- Cohort 2B: Have histologically or cytologically confirmed diagnosis of recurrent unresectable or metastatic breast cancer that is documented as HER2-negative and either HR-negative or HR-positive per American Society of...
- Cohort 2D:
- Histologically and/or cytologically documented metastatic adenocarcinoma and squamous carcinoma of GC/GEJC. (Note: ESCC is excluded).
- (2L subgroup): Had disease progression during or after one prior line of anti-cancer therapy for recurrent/metastatic disease.
- (3L subgroup): Has received two or more lines of prior anti-cancer therapy for recurrent/metastatic disease.
- (HER2-expression positive subgroup): Has received at least one prior line of systemic therapy for recurrent or metastatic disease, including a HER2-targeted agent in accordance with local SoC.
- Cohort 2E:
- Histologically and/or cytologically documented recurrent unresectable metastatic colorectal adenocarcinoma.
- Must have received at least one line to a maximum of three lines of prior SoC treatment for recurrent/metastatic disease.
- Cohort 1G and 2F:
- Histologically and/or cytologically documented recurrent unresectable metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology.
- Must have received platinum-based chemotherapy, with or without an anti-PD-(L)1 agent and bevacizumab for metastatic/recurrent disease, unless the patient is not a candidate in the opinion of the treating physician. Key
What rules you out
- (applicable to all participants and all parts unless otherwise specified):
- Have a history of intolerance to treatment with a topoisomerase I inhibitor or intolerance to an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and deruxtecan...
- Have an uncontrolled concomitant or intercurrent illness that contra-indicates study participation, limits compliance with study procedures or substantially increases the risk of incurring adverse events, including:
- Bleeding diathesis or active hemorrhage,
- Active infection,
- Child-Pugh class B or C cirrhosis,
- Pulmonary disease with significant impact in lung function
- Oncologic emergencies or complications (e.g., malignant hypercalcemia, superior vena cava syndrome, carcinoid syndrome that is unstable and with available alternative therapies),
- Psychiatric or abuse condition
- Infectious colitis Grade ≥2 not resolved to Grade 1 within 72 hours within the past 3 months.
- Have LVEF \<50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment.
- Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment.
- Have a history of (non-infectious) interstitial lung disease (ILD) /pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening...
- Are a participant of child-bearing potential who are pregnant or breastfeeding or are planning pregnancy within 225 days (\~7.5 months) after receiving last dose of BNT326 and within 6 months after last dose of BNT327...
- Are potentially fertile males, who are planning to father children during the study or within 135 days (\~4.5 months) after the last dose of BNT326 and within 6 months after last dose of BNT327, whichever is longer.
- Are subject to exclusion periods from another investigational study.
- Specific to BNT327: Participants with significant risks of hemorrhage or evidence of major coagulation disorders as specified in the protocol.
- Specific to BNT327: Have a history of intolerance to treatment with an anti-VEFG, anti-PD-1/PDL-1, or similar substance, including, but not limited to, bevacizumab, ramucirumab, atezolizumab, pembrolizumab, nivolumab...
- Cohort 1E: Have histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- San Francisco, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Madison, Wisconsin, United States
- Blacktown, New South Wales, Australia
- Darlinghurst, New South Wales, Australia
- Wollstonecraft, New South Wales, Australia
+ 34 more site(s).
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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; San Francisco, California, United States; Hartford, Connecticut, United States; New Haven, Connecticut, United States; Sarasota, Florida, United States; Tampa, Florida, United States and 48 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 ClinicalTrials.gov; the study team decides eligibility.