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

NCT05653180 | Unknown Phase 1

• 1 other identifier: CIBI310J201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Investigator evaluated ORR per RECIST V1.1

  up to 24 months

Secondary Outcomes (4)

• progression free survival, PFS

  up to 24 months

• duration of response, DoR

  up to 24 months

• disease control rate, DCR

  up to 24 months

• Overall Survival,OS

  up to 24 months

Study Arms (1)

IBI310+ sintilimab

EXPERIMENTAL

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; Drug: sintilimab

Interventions

IBI310 DRUG

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

IBI310+ sintilimab

sintilimab DRUG

200mg IV Q3W

Also known as: IBI308

IBI310+ sintilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hunan cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Interventions

sintilimab

Central Study Contacts

Tengfei Zhou

CONTACT

+86 0512-69566088; tengfei.zou@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 16, 2022
• Study Start: March 10, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

CN (1)