Advanced Biliary Tract CancerPhase 1/2NCT05653180
IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer
A Phase 1/2 study testing IBI310 and sintilimab in people with Advanced Biliary Tract Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This research study is designed to establish whether the combination of IBI310 \& Sintilimab has efficacy in patients with advanced BTC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Biliary Tract Cancer
- What is being tested?
- IBI310 and sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2023to 1 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan cancer Hospital
Changsha, Hunan, 410000
Tao Zhang, +86 027-85726114, 1277577866@qq.com
Jia Luo, +86 0731-89762030, luojia@hnca.org.cn
About this study
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)
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
- Being tested
- IBI310, sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI310Drug
2mg/kg IV,3 weeks later, 1mg/kg IV Q6W
sintilimabDrug
Also called IBI308
200mg IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: IBI310; Drug: sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Investigator evaluated ORR per RECIST V1.1
Measured: up to 24 months
Secondary outcomes (4)
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.
Measured: 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;
Measured: 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
Measured: up to 24 months
Overall Survival,OS
OS is defined as the time from enrollment to the date of death.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start10 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653180
- Sponsor's protocol ID
- CIBI310J201
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05653180
- Acronym / sponsor ID
- CIBI310J201
- Conditions
- Advanced Biliary Tract Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is designed to establish whether the combination of IBI310 \& Sintilimab has efficacy in patients with advanced BTC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI310+ sintilimab | Experimental | Drug: IBI310, Drug: sintilimabAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3102mg/kg IV,3 weeks later, 1mg/kg IV Q6W | Drug | IBI310+ sintilimab |
| sintilimabAlso: IBI308200mg IV Q3W | Drug | IBI310+ sintilimab |
Primary outcome
Objective response rate (ORR)
Time frame: up to 24 months
Investigator evaluated ORR per RECIST V1.1
4 secondary outcomes
progression free survival, PFS
Time frame: up to 24 months
duration of response, DoR
Time frame: up to 24 months
disease control rate, DCR
Time frame: up to 24 months
Overall Survival,OS
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
Related trials for Advanced Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
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RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
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Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
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RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IBI310 and sintilimab in people with Advanced Biliary Tract Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tengfei Zhou (+86 0512-69566088, tengfei.zou@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.