AMLPhase 1NCT04443751
A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
A Phase 1 study testing SHR-1702 in people with AML and MDS, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study will assess the safety and preliminary efficacy of escalating doses of SHR-1702 monotherapy in relapsed/refractory AML and intermediate-high risk MDS Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SHR-1702
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to 28 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
- Male or female.
- ≥18 years of age.
- Refractory/Relapsed AML, or failed to achieve complete remission after 2 cycles of induction therapy.
- Intermediate, High and very high risk MDS according to the revised International Prognostic Scoring System (IPSS-R) who have failed prior therapies, such as azacitidine and decitabine (Scoring≥3.5).
- Life expectancy≥12 months.
- With Adequate hematologic and organ function
- Signed inform consent form
Who cannot join
- With a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- With significant cardiovascular disease.
- With a history of autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
- Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C.
- Active or untreated central nervous system (CNS) metastases.
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- Active infection within 2 weeks.
- Know to be allergic to the ingredients of SHR-1702 injection.
- Prior allogeneic bone marrow transplantation or solid organ transplant
- With a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Blood disease hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300041
About this study
Official title: A Phase I, Multicenter, Open-label Study of SHR-1702 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
This study will assess the safety and preliminary efficacy of escalating doses of SHR-1702 monotherapy in relapsed/refractory AML and intermediate-high risk MDS
- Being tested
- SHR-1702
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1702Drug
SHR-1702 monotherapy, administered IV
| Study group | Role | What they receive |
|---|---|---|
| SHR-1702 monotherapy | Experimental | SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion. Receives: Drug: SHR-1702 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.
Measured: 6 months
Secondary outcomes (9)
Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of SHR-1702 monotherapy in AML and MDS patients
Measured: 2 years
Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS
Measured: 2 years
Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS
Measured: 2 years
Immunogenicity as assessed by the presence of anti-drug antibodies
Anti SHR-1702 antibodies will be tested frequently
Measured: 2 years
Pharmacodynamic profile as assessed by receptor occupancy
SHR-1702 receptor occupation
Measured: 2 years
Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006
Measured: 2 years
Best of Response（BOR）for SHR-1702 in AML or high risk MDS
Measured: 2 years
Progression-Free Survival（PFS) for SHR-1702 in AML or high risk MDS
Measured: 2 years
Overall Survival（OS) for SHR-1702 in AML or high risk MDS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start10 Sep 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443751
- Sponsor's protocol ID
- SHR-1702-I-102
- Status last verified
- Aug 2023
- First submitted
- 17 Jun 2020
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label Study of SHR-1702 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT04443751
- Acronym / sponsor ID
- SHR-1702-I-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 23 Jun 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 will assess the safety and preliminary efficacy of escalating doses of SHR-1702 monotherapy in relapsed/refractory AML and intermediate-high risk MDS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1702 monotherapy | Experimental | Drug: SHR-1702SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female.
- ≥18 years of age.
- Refractory/Relapsed AML, or failed to achieve complete remission after 2 cycles of induction therapy.
- Intermediate, High and very high risk MDS according to the revised International Prognostic Scoring System (IPSS-R) who have failed prior therapies, such as azacitidine and decitabine (Scoring≥3.5).
- Life expectancy≥12 months.
Key exclusion criteria (10 listed)
- With a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- With significant cardiovascular disease.
- With a history of autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
- Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C.
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 |
|---|---|---|
| SHR-1702SHR-1702 monotherapy, administered IV | Drug | SHR-1702 monotherapy |
Primary outcome
The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.
Time frame: 6 months
9 secondary outcomes
Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of SHR-1702 monotherapy in AML and MDS patients
Time frame: 2 years
Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS
Time frame: 2 years
Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS
Time frame: 2 years
Immunogenicity as assessed by the presence of anti-drug antibodies
Time frame: 2 years
Pharmacodynamic profile as assessed by receptor occupancy
Time frame: 2 years
Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006
Time frame: 2 years
Best of Response（BOR）for SHR-1702 in AML or high risk MDS
Time frame: 2 years
Progression-Free Survival（PFS) for SHR-1702 in AML or high risk MDS
Time frame: 2 years
Overall Survival（OS) for SHR-1702 in AML or high risk MDS
Time frame: 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 24 Aug 2023.
- Individual participant dataSharing planned: No
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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 SHR-1702 in people with AML and MDS, run by Jiangsu HengRui Medicine 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 7 inclusion and 10 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 24 Aug 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?
The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS. (time frame: 6 months). 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 24 Aug 2023.