Advanced Lung CancerPhase 1NCT04672356
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
A Phase 1 study testing IBI939 and Sintilimab in people with Advanced Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- IBI939 and Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2021to 1 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the Informed Consent Form;
- Male or female ≥ 18 and≤75 years of age;
- Life expectancy ≥ 12 weeks;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
- Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
- Histologically or cytologicallyconfirmed non-small cell lung or small cell lung cancer
Who cannot join
- Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
- Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
- Received any investigational agent within 4 weeks prior to the first dose of study drug;
- Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
- Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
- Conditions
- Advanced Lung Cancer
- Being tested
- IBI939, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI939Biological
IBI939 injection
SintilimabBiological
Sintilimab injection
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia: IBI939 in combination with Sintilimab | Experimental | IBI939 10mg/kg combination with Sintilimab Receives: Biological: IBI939; Biological: Sintilimab |
| Phase Ia:IBI939 in combination with Sintilimab | Experimental | IBI939 20mg/kg combination with Sintilimab Receives: Biological: IBI939; Biological: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 3 months
Recommended Phase II Dose(RP2D)
Measured: 2 months
Secondary outcomes (11)
Objective response rate(ORR)
Proportion of subjects with complete response (CR) or partial response (PR).
Measured: 6 months
Disease Control Rate(DCR)
Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
Measured: 6 months
Time to Objective Response (TTR)
Time from randomization to first objective tumor response (CR or PR).
Measured: 6 months
Duration of Response (DoR)
The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.
Measured: 6 months
Progression-free survival(PFS)
The time from randomization to the first occurrence of objective disease progression or death
Measured: 6 months
Area under the plasma concentration-time curve (AUC)
Measured: 24 hours
Maximum concentration (Cmax)
Measured: 24 hours
Trough concentration (Cmin)
Measured: 24 hours
Clearance (CL)
Measured: 24 hours
Volume of distribution (V)
Measured: 24 hours
Half-life (t1/2)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start25 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Cheng, Principal investigator, Jilin Province Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672356
- Sponsor's protocol ID
- CIBI939A102(Ia)
- Status last verified
- Jun 2023
- First submitted
- 13 Dec 2020
- Last updated
- 22 Jun 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT04672356
- Acronym / sponsor ID
- CIBI939A102(Ia)
- Conditions
- Advanced Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 17 Dec 2020 (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 study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ia: IBI939 in combination with Sintilimab | Experimental | Biological: IBI939, Biological: SintilimabIBI939 10mg/kg combination with Sintilimab |
| Phase Ia:IBI939 in combination with Sintilimab | Experimental | Biological: IBI939, Biological: SintilimabIBI939 20mg/kg combination with Sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed the Informed Consent Form;
- Male or female ≥ 18 and≤75 years of age;
- Life expectancy ≥ 12 weeks;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
- Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
Key exclusion criteria (5 listed)
- Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
- Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
- Received any investigational agent within 4 weeks prior to the first dose of study drug;
- Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
- Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
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 |
|---|---|---|
| IBI939IBI939 injection | Biological | Phase Ia: IBI939 in combination with Sintilimab, Phase Ia:IBI939 in combination with Sintilimab |
| SintilimabSintilimab injection | Biological | Phase Ia: IBI939 in combination with Sintilimab, Phase Ia:IBI939 in combination with Sintilimab |
Primary outcome
Adverse Events
Time frame: 3 months
Recommended Phase II Dose(RP2D)
Time frame: 2 months
11 secondary outcomes
Objective response rate(ORR)
Time frame: 6 months
Disease Control Rate(DCR)
Time frame: 6 months
Time to Objective Response (TTR)
Time frame: 6 months
Duration of Response (DoR)
Time frame: 6 months
Progression-free survival(PFS)
Time frame: 6 months
Area under the plasma concentration-time curve (AUC)
Time frame: 24 hours
Maximum concentration (Cmax)
Time frame: 24 hours
Trough concentration (Cmin)
Time frame: 24 hours
Clearance (CL)
Time frame: 24 hours
Volume of distribution (V)
Time frame: 24 hours
Half-life (t1/2)
Time frame: 24 hours
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 22 Jun 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.
Ying Cheng principal investigator
Jilin Province Cancer Hospital
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 IBI939 and Sintilimab in people with Advanced Lung 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: finished, as of the sponsor's last update on 22 Jun 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?
Adverse Events (time frame: 3 months). The study lists 2 primary outcomes in all. 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 22 Jun 2023.