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

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05653180

Collaborator

(none)

Enrollment

Location

Arm

16.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Biliary Tract Cancer	Drug: IBI310 Drug: sintilimab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Jan 19, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: IBI310 2mg/kg IV,3 weeks later, 1mg/kg IV Q6W Drug: sintilimab 200mg IV Q3W Other Names: IBI308

Arm

Intervention/Treatment

Experimental: 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).

Drug: IBI310

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

Drug: sintilimab

200mg IV Q3W

Other Names:

IBI308

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR) [up to 24 months]
Investigator evaluated ORR per RECIST V1.1

Secondary Outcome Measures

progression free survival, PFS [up to 24 months]
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.
duration of response, DoR [up to 24 months]
Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;
disease control rate, DCR [up to 24 months]
Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD
Overall Survival,OS [up to 24 months]
OS is defined as the time from enrollment to the date of death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.
Aged ≥18 years.
Patients with unresectable or relapsed or metastatic advanced Biliary tract cancer,and diagnosed by histology/cytology (except carcinoma of ampulla).
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).
Patients who have never received any anti-PD-1, anti-PD-L1/L2 antibody, anti-CTLA-4 antibody, or other immunotherapy.
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:

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.
Patients who have previously received organ or bone marrow transplantation.
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.
Uncontrollable hypertension, systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after best medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan cancer Hospital	Changsha	Hunan	China	410000

Sponsors and Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Innovent Biologics (Suzhou) Co. Ltd.

ClinicalTrials.gov Identifier:

NCT05653180

Other Study ID Numbers:

CIBI310J201

First Posted:

Dec 16, 2022

Last Update Posted:

Dec 16, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Biliary Tract Neoplasms

Study Results

No Results Posted as of Dec 16, 2022