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

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Biliary Tract Cancer
• Intervention / Treatment: Drug: IBI310; Drug: sintilimab

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tengfei Zhou; Phone Number: +86 0512-69566088; Email: tengfei.zou@innoventbio.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Tao Zhang; Phone Number: +86 027-85726114; Email: 1277577866@qq.com
      • Contact: Jia Luo; Phone Number: +86 0731-89762030; Email: luojia@hnca.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Investigator evaluated ORR per RECIST V1.1	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Overall Survival,OS	OS is defined as the time from enrollment to the date of death.	up to 24 months

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: CIBI310J201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No