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

Advanced Biliary Tract Cancer Clinical Trial

Official title:

A Single Arm,Multi-center,Phase Ib/II Clinical Study Evaluating IBI310 Combined With Sintilimab in Patients With Advanced Biliary Tract Cance(BTC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653180
• Other study ID #: CIBI310J201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 10, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Tengfei Zhou
• Phone: +86 0512-69566088
• Email: tengfei.zou[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• IBI310
2mg/kg IV,3 weeks later, 1mg/kg IV Q6W
• sintilimab
200mg IV Q3W

Locations

Country	Name	City	State
China	Hunan cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Investigator evaluated ORR per RECIST V1.1	up to 24 months
Secondary	progression free survival, PFS	PFS is defined as the time from first treatment to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1), or death due to any cause.	up to 24 months
Secondary	duration of response, DoR	Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;	up to 24 months
Secondary	disease control rate, DCR	Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD	up to 24 months
Secondary	Overall Survival,OS	OS is defined as the time from enrollment to the date of death.	up to 24 months