Myelodysplastic SyndromesPhase 1NCT04485065
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
A Phase 1 study testing IBI188+azacitidine in people with Myelodysplastic Syndromes, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- IBI188+azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2020to 20 Aug 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MDS subjects with higher risk;
- Age ≥ 18 years old;
- Eastern Cooperative Oncology Group score of 0~1;
- Not suitable for or refuse to receive HSCT;
- Newly diagnosed MDS subjects;
- Adequate organ function;
- Subjects should take effective contraceptive measures
- Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Who cannot join
- Subject who has transformed from MDS to AML.
- Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
- MDS subjects with lower risk.
- Subjects who have received chemotherapy.
- Prior exposure to any anti-CD47 or anti-SIRPα agents.
- Subjects participating in another interventional clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome
The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome
- Conditions
- Myelodysplastic Syndromes
- Being tested
- IBI188+azacitidine
- Keywords
- MDS
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI188+azacitidineDrug
Escalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W
Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W
| Study group | Role | What they receive |
|---|---|---|
| IBI188+azacitidine | Experimental | Not described Receives: Drug: IBI188+azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)
Measured: 24 months
Complete response rate (CR) and duration of complete response (DoCR)
Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the central laboratory.
Measured: 24 months
Secondary outcomes (1)
Complete response rate (CR) and duration of complete response (DoCR)
Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the investigators;
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start30 Sep 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion20 Aug 2024 (estimated)
Why it stopped: Suspended for changes in development strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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
- 120 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
- NCT04485065
- Sponsor's protocol ID
- CIBI188C301
- Status last verified
- Feb 2023
- First submitted
- 21 Jul 2020
- Last updated
- 16 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT04485065
- Acronym / sponsor ID
- CIBI188C301
- Conditions
- Myelodysplastic Syndromes
- Keywords
- MDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Suspended for changes in development strategy
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 24 Jul 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.
The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI188+azacitidine | Experimental | Drug: IBI188+azacitidine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- MDS subjects with higher risk;
- Age ≥ 18 years old;
- Eastern Cooperative Oncology Group score of 0~1;
- Not suitable for or refuse to receive HSCT;
- Newly diagnosed MDS subjects;
Key exclusion criteria (6 listed)
- Subject who has transformed from MDS to AML.
- Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
- MDS subjects with lower risk.
- Subjects who have received chemotherapy.
- Prior exposure to any anti-CD47 or anti-SIRPα agents.
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 |
|---|---|---|
| IBI188+azacitidineEscalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W | Drug | IBI188+azacitidine |
Primary outcome
Safety and tolerability
Time frame: 24 months
To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)
Complete response rate (CR) and duration of complete response (DoCR)
Time frame: 24 months
Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the central laboratory.
1 secondary outcome
Complete response rate (CR) and duration of complete response (DoCR)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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 IBI188+azacitidine in people with Myelodysplastic Syndromes, 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 8 inclusion and 6 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: paused, as of the sponsor's last update on 16 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?
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?
Safety and tolerability (time frame: 24 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 16 Feb 2023.