IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer

NCT ID: NCT05653180

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2024-06-01

Brief Summary

This research study is designed to establish whether the combination of IBI310 & Sintilimab has efficacy in patients with advanced BTC

Conditions

Advanced Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI310+ sintilimab

All Subjects will be treated with : Sintilimab 200mg IV Q3W continuously and IBI310 2mg/kg IV single dose, 3 weeks later, IBI310 maintenance dose is 1mg/kg IV Q6W until progression (treatment duration up to 24 months).

Group Type: EXPERIMENTAL

IBI310

Intervention Type: DRUG

2mg/kg IV,3 weeks later, 1mg/kg IV Q6W

sintilimab

Intervention Type: DRUG

200mg IV Q3W

Interventions

IBI310

2mg/kg IV,3 weeks later, 1mg/kg IV Q6W

Intervention Type: DRUG

sintilimab

200mg IV Q3W

Intervention Type: DRUG

Other Intervention Names

IBI308

Eligibility Criteria

Inclusion Criteria

1. The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.

2. Aged ≥18 years.

3. Patients with unresectable or relapsed or metastatic advanced Biliary tract cancer,and diagnosed by histology/cytology (except carcinoma of ampulla).

4. Had progressed after receiving at least first-line systemic treatment (if a patient has progressed within 6 months after receiving systemic treatment during adjuvant chemotherapy or concurrent radiochemotherapy, she will be deemed to have received first-line treatment).

5. Patients who have never received any anti-PD-1, anti-PD-L1/L2 antibody, anti-CTLA-4 antibody, or other immunotherapy.

6. The subject must have at least one measurable lesion as the target lesion (according to RECIST V1.1). A measurable lesion in the radiation field from previous radiotherapy or local treatment, can also be chosen as the target lesion if confirmed progression.

Exclusion Criteria

1. Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma.

2. Patients who have previously received organ or bone marrow transplantation.

3. Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA >103 copies/ml;. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.

4. Uncontrollable hypertension, systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after best medical treatment, history of hypertensive crisis or hypertensive encephalopathy.

5. Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage , patients who only shows with a few pleural effusion, ascites, and pericardial effusion by imaging and with no clinical symptoms can be selected.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hunan cancer Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tengfei Zhou

Role: CONTACT

tengfei.zou@innoventbio.com

+86 0512-69566088

Facility Contacts

Tao Zhang

Role: primary

1277577866@qq.com

+86 027-85726114

Jia Luo

Role: backup

luojia@hnca.org.cn

+86 0731-89762030

Other Identifiers

CIBI310J201

Identifier Type: -

Identifier Source: org_study_id