Clinical trial 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 being studied as a potential treatment for advanced solid tumors.
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
- The study aims to see how safe BNT326 is, find the best dose, and learn how it behaves in the body. It also looks at whether BNT326 works alone or with other experimental cancer drugs.
- Who it's for
- It is looking for adults who have advanced solid tumors that have spread or come back after other treatments.
- What's involved
- Participants will receive BNT326 either by itself or together with other experimental cancer drugs. They will have regular visits for medical checks, blood tests, and imaging scans to monitor safety and tumor response.
- Time commitment
- The study lasts several months, with multiple clinic visits for treatment, monitoring, and follow‑up tests.
- 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
- 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.
- Have measurable disease defined by RECIST v1.1.
- 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.
You likely can't join if
- Have a history of intolerance to treatment with a topoisomerase I inhibitor or intolerance to an ADC that consists of a topoisomerase I inhibitor...
- Bleeding diathesis or active hemorrhage,
- Active infection,
- Child-Pugh class B or C cirrhosis,
- Known 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...
See the full eligibility criteria
Who can join
- 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.
- Have measurable disease defined by RECIST v1.1.
- 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.
- 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.
- Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase rearrangements, or other genomic alterations for which targeted molecular therapies are available.
- 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 in the metastatic setting, which can include anti-PD-1/PD-L1 therapy (if PD-L1 positive), chemotherapy, and anti-angiogenic agents.
- 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.
- Have histologically or cytologically confirmed diagnosis of unresectable or metastatic acral/uveal/mucosal melanoma not amenable to local therapy.
- 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.
- 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...
- Histologically and/or cytologically documented metastatic adenocarcinoma and squamous carcinoma of GC/GEJC. (Note: Esophageal squamous-cell carcinoma 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.
- 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.
- 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
- 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...
- Bleeding diathesis or active hemorrhage,
- Active infection,
- Child-Pugh class B or C cirrhosis,
- Known 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...
- 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 pumitamig, whichever is longer.
- Are subject to exclusion periods from another investigational study.
- Specific to pumitamig: Participants with significant risks of hemorrhage or evidence of major coagulation disorders as specified in the protocol.
- Specific to pumitamig: Have a history of intolerance to treatment with an anti-vascular endothelial growth factor, anti-PD-1/PDL-1, or similar substance, including, but not limited to, bevacizumab, ramucirumab...
- 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 is enrolling
- 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
- 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
- Southport, Queensland, Australia
- Adelaide, South Australia, Australia
- Frankston, Victoria, Australia
+ 38 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, but 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?
This study is enrolling now at 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 and 52 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.