Advanced MalignanciesPhase 1NCT04353830
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors
A Phase 1 study testing IBI939 and IBI939+ Sintilimab in people with Advanced Malignancies, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- IBI939 and IBI939+ Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2020to 11 May 2022
- 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
- Able to understand and willing to sign the ICF.
- Adults 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy at least 12 weeks.
- Adequate organ and bone marrow function.
- Eligibility Criteria：
Show all 20Show fewer
- Previous exposure to any anti-TIGIT antibody.
- Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
- Any investigational drugs received within 4 weeks prior to the first study treatment.
- Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
- Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
- Medication requiring long-term systemic hormones or any other immunosuppression therapy.
- Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.
- Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
- History of autoimmune disease , present active autoimmune disease or inflammatory diseases
- Positive human immunodeficiency virus (HIV) test.
- Active hepatitis B or C, or tuberculosis.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Known history of hypersensitivity to any components of the IBI939 or Sintilimab.
- Pregnant or nursing females.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies
- Conditions
- Advanced Malignancies
- Being tested
- IBI939, IBI939+ Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI939Drug
Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.
IBI939+ SintilimabDrug
IBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.
IBI939+ SintilimabDrug
IBI939: IBI939 in combination with Sintilimab will be given with RP2D. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia Dose-Escalation Stage:IBI939 | Experimental | Participants will be treated with escalating doses of IBI939 to determine the MTD. Receives: Drug: IBI939 |
| Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab | Experimental | Participants will be treated with escalating doses of IBI939 in combination with a fixed dose of Sintilimab to determine the MTD. Receives: Drug: IBI939+ Sintilimab |
| Phase Ib Expansion Stage:IBI939+ Sintilimab | Experimental | Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI939 in combination with Sintilimab in different cancer types. Receives: Drug: IBI939+ Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with AEs and SAEs
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ]
Measured: up to 2 years after enrollment
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.
Measured: From Baseline to the end of Cycle 1
Secondary outcomes (4)
Pharmacokinetics: AUC
The area under the curve (AUC) of serum concentration of the drug after the administration.
Measured: up to 2 years after enrollment
Pharmacokinetics: Cmax
Maximum concentration (Cmax) of the drug after administration
Measured: up to 2 years after enrollment
Immunogenicity: Percentage of ADA positive subjects
Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI939.
Measured: up to 2 years after enrollment
Preliminary anti-tumor activity (Objective Response Rate)
Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors.
Measured: up to 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start22 May 2020
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT04353830
- Sponsor's protocol ID
- CIBI939A101
- Status last verified
- Feb 2023
- First submitted
- 17 Apr 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT04353830
- Acronym / sponsor ID
- CIBI939A101
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 20 Apr 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 is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia Dose-Escalation Stage:IBI939 | Experimental | Drug: IBI939Participants will be treated with escalating doses of IBI939 to determine the MTD. |
| Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab | Experimental | Drug: IBI939+ SintilimabParticipants will be treated with escalating doses of IBI939 in combination with a fixed dose of Sintilimab to determine the MTD. |
| Phase Ib Expansion Stage:IBI939+ Sintilimab | Experimental | Drug: IBI939+ SintilimabParticipants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI939 in combination with Sintilimab in different cancer types. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Able to understand and willing to sign the ICF.
- Adults 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy at least 12 weeks.
- Adequate organ and bone marrow function.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IBI939Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit. | Drug | Phase Ia Dose-Escalation Stage:IBI939 |
| IBI939+ SintilimabIBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit. | Drug | Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab |
| IBI939+ SintilimabIBI939: IBI939 in combination with Sintilimab will be given with RP2D. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit. | Drug | Phase Ib Expansion Stage:IBI939+ Sintilimab |
Primary outcome
Number of subjects with AEs and SAEs
Time frame: up to 2 years after enrollment
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ]
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: From Baseline to the end of Cycle 1
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.
4 secondary outcomes
Pharmacokinetics: AUC
Time frame: up to 2 years after enrollment
Pharmacokinetics: Cmax
Time frame: up to 2 years after enrollment
Immunogenicity: Percentage of ADA positive subjects
Time frame: up to 2 years after enrollment
Preliminary anti-tumor activity (Objective Response Rate)
Time frame: up to 2 years after enrollment
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 1 Mar 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 IBI939 and IBI939+ Sintilimab in people with Advanced Malignancies, 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 20 inclusion and 0 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 1 Mar 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?
Number of subjects with AEs and SAEs (time frame: up to 2 years after enrollment). 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 1 Mar 2023.