Trial · NCT07885397
Sonrotoclax Plus Azacitidine in Patients With MDS-IB2
NCT07885397, Phase 1, Phase 2, Recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sonrotoclax Plus Azacitidine in Patients With MDS-IB2. Trials, record NCT07885397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07885397
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sonrotoclax Plus Azacitidine in Patients With MDS-IB2
- NCT number
- NCT07885397
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Conditions
- Myelodysplastic Syndromes, High Risk
- Interventions
- Sonrotoclax, Azacitidine (AZA)
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-Limiting Toxicities (DLTs) | Cycle 1 Day 1 through Cycle 1 Day 28; up to Day 42 if required for assessment of unresolved hematologic toxicity. | Incidence of protocol-defined DLTs during the first treatment cycle. |
| Primary | Maximum Tolerated Dose / Recommended Phase 2 Dose | Through completion of the Phase Ib dose-escalation stage, approximately 12 months | Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Sonrotoclax |
| Primary | Composite Response Rate (CRR) | From the first dose through completion of up to 4 treatment cycles, approximately 4 months | Proportion of participants achieving complete remission (CR), complete remission with limited count recovery (CRL), or complete remission with partial hematologic recovery (CRh). |
| Secondary | Duration of Response (DoR) | Up to 36 months | Time from the first documented response to disease progression, relapse, or death from any cause, whichever occurs first. |
| Secondary | Measurable Residual Disease (MRD) Negativity Rate | From baseline through the end of study treatment, up to approximately 12 months | Proportion of evaluable participants who achieve MRD-negative status during study treatment. |
| Secondary | Progression-Free Survival (PFS) | From the date of the first dose of study treatment to the date of the first documented disease progression, transformation to acute myeloid leukemia, or death from any cause, whichever occurs first, assessed up to 36 months. | Time from the first dose of study treatment to the first documented disease progression, transformation to acute myeloid leukemia, or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 36 months | Time from the first dose of study treatment to death from any cause. |
| Secondary | Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Rate | Up to 36 months | Proportion of participants who undergo allogeneic hematopoietic stem cell transplantation after treatment with sonrotoclax plus azacitidine. |
| Secondary | Incidence of Treatment-Emergent Adverse Events | From the first dose of study treatment through 30 days after the last dose, assessed up to 12 months. | Incidence and severity of treatment-emergent adverse events, serious adverse events, Grade 3 or higher adverse events, infections, and tumor lysis syndrome. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07885397
GET https://conductscience.org/api/trials/v1/NCT07885397/registered