Study of IBI363 in Patients with Advanced First-line Gastric Cancer
ConditionIBI363 + Chemotherapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXiangdong Cheng
About this trial
This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects, ≥ 18 years and ≤75 years.
Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
Subjects with at least one measurable lesion according to RECIST v1.1.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Disqualifiers
Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
Active uncontrolled bleeding or a known bleeding diathesis.
Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
Trial design
Design model
Single group
Treatments tested in this trial
IBI363
DrugIBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Cohort 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame
Through out the study (up to 2 years)2
Disease control rate (DCR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame
Through out the study (up to 2 years)Secondary outcomes
1
Progression Free Survival（PFS）;
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame
Up to 2 years2
Overall Survival, OS）
The efficacy of solid tumors was evaluated according to RECIST v1.1
Time frame
Up to 2 years3
Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Time frame
Up to 90 days after the last administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiangdong Cheng
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov