KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute
About this trial
The goal of this Interventional clinical trial is to learn about the efficacy and safety of KN026 and chemotherapy ± KN046 in HER2-positive metastatic colorectal cancer and biliary tract cancer. Participants will receive standard first-line chemotherapy (capecitabine + oxaliplatin) combined with KN026 (a HER2-targeted bispecific antibody) ± KN046 （a PD-L1/CTLA-4 targeted bispecific antibody）.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants are able to comprehend the informed consent information and sign the informed consent form.
Participants ≥ 18 years old, of any gender.
Cohorts A and B: Histologically confirmed unresectable HER2-positive metastatic colorectal cancer, meeting the following criteria: a) Previously untreated with systemic anti-tumor therapy, or the time from (neo)adjuvant chemotherapy completion to disease recurrence > 6 months; b) Gene sequencing shows wild-type RAS and BRAF (participants' previous KRAS and BRAF test results are acceptable).
Cohort C: Histologically confirmed unresectable HER2-positive biliary tract cancer, including intrahepatic or extrahepatic bile duct cancer or gallbladder cancer: a) Previously untreated with systemic anti-tumor therapy; b) If previously received (neo)adjuvant radiotherapy, the time from treatment completion to disease recurrence is > 6 months.
Disqualifiers
Subjects with untreated active brain metastases or leptomeningeal metastases; if subjects have received treatment for brain metastases and the lesions are stable (stable brain imaging for at least 4 weeks before the first dose with no evidence of new or enlarging brain lesions and no new neurological symptoms or stable neurological symptoms at baseline), they are allowed to be enrolled.
Ampullary carcinoma.
Previous history of receiving any systemic anticancer therapy for metastatic tumors or participation in interventional clinical trials.
Within 14 days before the first dose, the subject requires a continuous 7-day treatment of systemic corticosteroids (≥10 mg/day prednisone or equivalent of other corticosteroids) or immunosuppressive agents; exceptions are inhaled or locally applied corticosteroids or physiological replacement doses of corticosteroids for adrenal insufficiency. Short-term (≤7 days) corticosteroids are allowed for prevention (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).
Trial design
Design model
Parallel
Treatments tested in this trial
KN026
DrugKN026 is a novel bispecific antibody that simultaneously binds to two distinct HER2 epitopes.
KN046
DrugKN046 is a novel bispecific antibody that blocks both PD-L1 interaction with PD-1 and CTLA-4 interaction with CD80/CD86.
XELOX
DrugXELOX is the standard first-line chemotherapy in metastatic colorectal cancer and biliary duct cancer.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: AExperimental treatment 2 interventions
Group B: BExperimental treatment 3 interventions
Group C: CExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Overall response rate
Objective response rate (defined as CR+PR) is reported based on investigator's evaluation.
Time frame
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-doseSecondary outcomes
1
Progression free survival
Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.
Time frame
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose2
Duration of response
Duration of response (DOR) is defined as the time from the date of the first response to the first objective documentation of radiographic progressive disease (PD) or death due to any cause.
Time frame
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose3
Disease control rate
Disease control rate (defined as CR+PR+SD) is reported based on investigator's evaluation.
Time frame
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-dose4
Time to response
Time to response (TOR) is defined as the time from the date of the first dose to the first objective documentation of radiographic objective response.
Time frame
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 24 months post-doseSponsors and contacts
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Source ClinicalTrials.gov
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