metastatic colorectal cancer
Conditions
Interventions
BNT314 and pumitamig combination therapy
Sponsors
IQVIA Services Japan G.K. jRCT Inquiry Contact Kazunori Takemura
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are only eligible for enrollment in this trial if all of the following criteria apply at screening: 1.Have unresectable histologically confirmed adenocarcinoma of the colon or rectum. 2.Have confirmed non-MSI-H/pMMR mCRC (per FDA/CE approved test or based on local testing). 3.Have known RAS status. 4.Have given informed consent by signing and dating an ICF in accordance with ICH GCP and local legislation before the initiation of any trial-specific procedures. 5.Are willing and able to comply with scheduled visits, treatment schedule, theplanned trial assessments (including participant completed diaries), lifestyle restrictions, and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions. 6.Aged >=18 years at the time of giving informed consent. 7.Have measurable disease defined by RECIST 1.1. 8.Must provide a tumor tissue sample (formalin-fixed, paraffin-embedded or tissue slides) collected before C1D1 for enrollment. A newly obtained tumor sample is preferred. If it is not feasible to obtain a recent tumor sample, participants can provide archival tumor tissue (less than 2 years prior treatment). Details are provided in the Laboratory Manual. 9.Have ECOG PS of 0 or 1. 10.Have a life expectancy of >=12 weeks. 11.Have an adequate organ and bone marrow function within <=7 days of Day 1. 12.Have had an adequate treatment washout period before randomization/enrollment. 13.Have no clinical signs and symptoms of pancreatitis and serum amylase and lipase <=1.5 x ULN at screening. Participants with values between ULN and <=1.5 x ULN require the approval of the trial Medical Monitor. 14.Agree not to enroll in another trial of an IMP, starting from the time of giving informed consent and continuously until the last planned visit in this trial. 15. For POCBP: Have a negative blood-based B-hCG pregnancy test at screening. Participants who are post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently sterilized (i.e., have had a hysterectomy, bilateral salpingectomy and bilateral oophorectomy, as verified by medical records) will not be considered POCBP and therefore are not required to undergo pregnancy testing. 16. For POCBP: Agree to practice a highly effective form of contraception and to require their potentially fertile male partners to use condoms starting at the time of giving informed consent and continuously 6 months after receiving the last dose of IMP. 17. For POCBP: Agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of IMP. 18. Are male who are sterile or if they are potentially fertile (i.e., are not surgically [e.g., have had a vasectomy] or congenitally sterile) and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their female sexual partners to practice a highly effective form of contraception during the trial, starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of IMP. 19. Are potentially fertile male who are willing to refrain from sperm donation, starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of IMP. 20. Participants must present with progressive disease at trial enrollment. Have histologicall
Exclusion criteria
Exclusion criteria: Participants are not eligible for enrollment in this trial if any of the following criteria apply at screening: 1. Confirmed MSI-H/dMMR mCRC. 2. Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol described requirements. 3. Prior treatment with EpCAM or 4-1BB targeted or immunotherapy. 4. Prior treatment with immune checkpoint inhibitors or PD(L)-1/VEGF bispecific antibody. 5. Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as radical" intent), per investigator's assessment. 6. Have an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs, including: a. Bleeding diathesis or active hemorrhage, b. Active infection, c. Child-Pugh class B or C cirrhosis, d. Pulmonary disease with significant impact in lung function, including a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. e. Oncologic emergencies or complications (e.g. malignant hypercalcemia, superior vena cava syndrome, carcinoid syndrome that is unstable and with available alternative therapies), f. Psychiatric or abuse condition. g. History of acute or chronic pancreatitis of any etiology within 6 weeks prior to the start of trial treatment. 7. Have uncontrolled or significant cardiovascular disease. 8. Have left ventricular ejection fraction (LVEF) =350 cells/mL per local laboratory. - Participants who have not had an opportunistic infection within the past 12 months should generally be eligible for the trial. b. Hepatitis B infection, as defined by the presence of HBsAg or HBV DNA positivity. Testing of HBV DNA is mandatory if HBC antibody is positive. c. Have an active Hepatitis C virus infection; individuals who have completed curative antiviral treatment with Hepatitis C virus viral load below the limit of quantification are allowed. 12. Have unresolved toxicities from previous anticancer therapy. 13. Are pregnant or breastfeeding or are planning pregnancy or cannot discontinue breastfeeding for the duration of the trial at least 9 months following the last dose of oxaliplatin or 6 months after receiving last dose of BNT314 and pumitamig if continued for >=3 months after the last dose of oxaliplatin. 14. Have a history of allergies, hyperse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Occurrence of DLTs during the DLT observation period (until 28 days after initiating BNT314 + pumitamig administration on Day 1 in Cycle 1[C1D1] or the day before Day 1 in Cycle 2[C2D1], whichever comes earlier). - Occurrence of TEAEs and TRAEs assessed according to CTCAE v5.0 including Grade >=3, serious, fatal TEAEs by relationship (from initiation of the first BNT314 + pumitamig dose until 90 days after last dose of IMP). - Occurrence of dose interruption or discontinuation of trial treatment due to TEAEs (from initiation of the first BNT314 + pumitamig dose until 90 days after last dose of IMP). | — |
Countries
Germany, Japan, Spain, UK, USA
Contacts
Public ContactIQVIA Services Japan G.K. jRCT Inquiry Contact
IQVIA Services Japan G.K.
Outcome results
None listed