NPCPhase 1NCT04945421
IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC
A Phase 1 study testing Sintilimab and IBI310 in people with NPC, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed prior Anti-PD-1/PD-L1 therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NPC
- What is being tested?
- Sintilimab and IBI310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2021to 6 Feb 2023
- Phase
- Phase 1
- 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
- Aged ≥18 years;
- ECOG 0 ~ 1;
- Histologically/cytologically confirmed R/M NPC;
- Failed to prior Anti-PD-1 resistance;
- Adequate organ and bone marrow function;
- Expected survival ≥12 weeks;
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- Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;
- Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
- At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).
Who cannot join
- Had tumors other than NPC within the past 5 years.
- Had allogeneic organ or stem cell transplantation.
- The presence of uncontrolled life-threatening illness
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
- HIV positive.
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- Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- Severe, uncontrolled medical conditions and infections.
- At the same time using other test drugs or in other clinical trials.
- Refusal or inability to sign informed consent to participate in the trial.
- Other treatment contraindications.
- Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
- Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
- Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phase Ib/II, Open-label, Multicenter Study of IBI310 (Anti-CTLA4 mAb) in Combination With Sintilimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma That Failed Prior Anti-PD-1/PD-L1 Therapy
This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed prior Anti-PD-1/PD-L1 therapy
- Conditions
- NPC
- Being tested
- Sintilimab, IBI310
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
IBI310Drug
(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab and IBI310 (single arm) | Experimental | The test group will be treated with either (IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first. Receives: Drug: Sintilimab; Drug: IBI310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(Objective response rate)
Investigator evaluated ORR per RECIST V1.1
Measured: Up to 2 years
Secondary outcomes (9)
DOR(Duration of Response)
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 2 years
PFS (Progress Free Survival)
defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;
Measured: Up to 2 years
OS (Overall Survival)
defined as the time from randomization to death of any cause in subjects without receiving any immunotherapy outside the study protocol for first-line treatment of advanced HCC;
Measured: Up to 2 years
DCR(Disease control rate)
defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD
Measured: Up to 2 years
TTR(Time to progress)
defined as the time from randomization to the first documented and confirmed objective response (CR or PR)
Measured: Up to 2 years
TEAE(Treatment Emergent Adverse Event)/SAE(Serious Adverse Event)
Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0, 2017) grade;
Measured: Up to 2 years
Changes of Quality of life, according to EORTC QLQ-C30
According to EORTC QLQ-C30
Measured: Up to 2 years
Changes of Quality of life, according to EORTC QLQ-H&N35
According to EORTC QLQ-H\&N35
Measured: Up to 2 years
ADAs
The immunogenicity of IBI310 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start23 Jul 2021
- Primary completion25 Apr 2022
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NPCStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT04945421
- Sponsor's protocol ID
- CIBI310F201
- Status last verified
- Feb 2023
- First submitted
- 7 Jun 2021
- Last updated
- 23 Feb 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 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase Ib/II, Open-label, Multicenter Study of IBI310 (Anti-CTLA4 mAb) in Combination With Sintilimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma That Failed Prior Anti-PD-1/PD-L1 Therapy
- ClinicalTrials.gov ID
- NCT04945421
- Acronym / sponsor ID
- CIBI310F201
- Conditions
- NPC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 30 Jun 2021 (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 is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed prior Anti-PD-1/PD-L1 therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab and IBI310 (single arm) | Experimental | Drug: Sintilimab, Drug: IBI310The test group will be treated with either (IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥18 years;
- ECOG 0 ~ 1;
- Histologically/cytologically confirmed R/M NPC;
- Failed to prior Anti-PD-1 resistance;
- Adequate organ and bone marrow function;
Key exclusion criteria (14 listed)
- Had tumors other than NPC within the past 5 years.
- Had allogeneic organ or stem cell transplantation.
- The presence of uncontrolled life-threatening illness
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
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 |
|---|---|---|
| Sintilimab(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first. | Drug | Sintilimab and IBI310 (single arm) |
| IBI310(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first. | Drug | Sintilimab and IBI310 (single arm) |
Primary outcome
ORR(Objective response rate)
Time frame: Up to 2 years
Investigator evaluated ORR per RECIST V1.1
9 secondary outcomes
DOR(Duration of Response)
Time frame: Up to 2 years
PFS (Progress Free Survival)
Time frame: Up to 2 years
OS (Overall Survival)
Time frame: Up to 2 years
DCR(Disease control rate)
Time frame: Up to 2 years
TTR(Time to progress)
Time frame: Up to 2 years
TEAE(Treatment Emergent Adverse Event)/SAE(Serious Adverse Event)
Time frame: Up to 2 years
Changes of Quality of life, according to EORTC QLQ-C30
Time frame: Up to 2 years
Changes of Quality of life, according to EORTC QLQ-H&N35
Time frame: Up to 2 years
ADAs
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sintilimab and IBI310 in people with NPC, 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 23 Feb 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(Objective response rate) (time frame: Up to 2 years). 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 23 Feb 2023.