MDSPhase 1NCT04511975
A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS
A Phase 1 study testing IBI188 and Azacitidine in people with MDS, run by Innovent Biologics (Suzhou) Co. Ltd. at 3 sites in United States.
Trial summary
This is an open-label, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of IBI188 in combination with Azacitidine in newly diagnosed higher risk MDS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDS
- What is being tested?
- IBI188 and Azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Aug 2020to 4 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Newly diagnosed MDS subjects with higher risk.
- Age ≥ 18 years old.
- Eastern Cooperative Oncology Group score of 0-2.
- Adequate organ function.
- Subjects should take effective contraceptive measures.
- Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Main Exclusion Criteria:
- Subject who has transformed from MDS to AML.
- MDS subjects with lower risk.
- Subjects who have received chemotherapy.
- History of chronic hemolytic anemia
- Prior exposure to any anti-CD47 or anti-SIRPα agents.
- Subjects participating in another interventional clinical study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
New Jersey Center for Cancer Research
Brick, New Jersey, 08724
Gabrail Cancer Center
Canton, Ohio, 44718
About this study
Official title: A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)
This is an open-label, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of IBI188 in combination with Azacitidine in newly diagnosed higher risk MDS patients.
- Conditions
- MDS
- Being tested
- IBI188, Azacitidine
- Keywords
- MDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI188Drug
IBI188: 100 mg/mL, intravenous infusion once a week
AzacitidineDrug
Also called VIDAZA
Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| IBI188 + azacitidine | Experimental | Participants will receive IBI188 in combination with azacitidine Receives: Drug: IBI188; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse events according to national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 or customized AE severity grading as defined in the protocol
Measured: 28 days
Efficacy of IBI188 in combination with AZA
International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start24 Aug 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion4 Apr 2022 (estimated)
Why it stopped: pause for further assessment and study adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDSStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Luo, Study director, Innovent Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511975
- Sponsor's protocol ID
- CIBI188A103
- Status last verified
- Dec 2020
- First submitted
- 5 Aug 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT04511975
- Acronym / sponsor ID
- CIBI188A103
- Conditions
- MDS
- Keywords
- MDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: pause for further assessment and study adjustment
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 4 Apr 2022 (estimated)
- First posted
- 13 Aug 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, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of IBI188 in combination with Azacitidine in newly diagnosed higher risk MDS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI188 + azacitidine | Experimental | Drug: IBI188, Drug: AzacitidineParticipants will receive IBI188 in combination with azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| IBI188IBI188: 100 mg/mL, intravenous infusion once a week | Drug | IBI188 + azacitidine |
| AzacitidineAlso: VIDAZAAzacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle | Drug | IBI188 + azacitidine |
Primary outcome
Adverse Events
Time frame: 28 days
Adverse events according to national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 or customized AE severity grading as defined in the protocol
Efficacy of IBI188 in combination with AZA
Time frame: 28 days
International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
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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.
Yi Luo study director
Innovent Biologics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI188 and Azacitidine in people with MDS, run by Innovent Biologics (Suzhou) Co. Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: paused, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Results are not available in the source record.
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: 28 days). 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 21 Dec 2020.