Ziftomenib in Acute myeloid leukaemia with 11q23 abnormality: NCT07355335 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Not yet recruiting
Recruitment status
24
Planned enrollment
2027-07-01
Primary-completion proxy
Executive view
NCT07355335 evaluates Ziftomenib in Acute myeloid leukaemia with 11q23 abnormality. The disclosed sponsor is The Massachusetts General Hospital, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], assessed over From the start of treatment until participant withdrawal, death, or removal from study, whichever comes first, assessed up to 2 years after initial dose of study treatment..
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07355335 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Acute myeloid leukaemia with 11q23 abnormality landscape. Drug & Asset MCP drug_fetch was queried for Ziftomenib, while Company & Deal Intelligence MCP organization_fetch was queried for The Massachusetts General Hospital.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07355335 | Ziftomenib | Phase 1 / Not yet recruiting | The Massachusetts General Hospital | United States | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] From the start of treatment until participant withdrawal, death, or r… | 2027-07-01 |
| NCT07471789 | CD84 Targeted CART(Gyala Therapeutics) | Phase 1/2 / Recruiting | Gyala Therapeutics SL | Spain | Number of Participants with Adverse Events. 2 years | 2029-05-31 |
| NCT07463768 | Ivosidenib | Phase 2 / Not yet recruiting | Sponsor not reported | France | RFS 24 months 24 months | 2030-09-01 |
| NCT07464951 | Ruxolitinib Phosphate | Phase 1 / Recruiting | The Children's Hospital of Philadelphia | United States | Evaluate the Safety of CART123 5 years | 2029-05-14 |
| ACTRN12626000278336 | Venetoclax | Not Applicable / Not yet recruiting | Australasian Leukaemia & Lymphoma Group | Australia | Timing not reported |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07355335 is a Phase 1, not yet recruiting study with 24 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]” over “From the start of treatment until participant withdrawal, death, or removal from study, whichever comes first, assessed up to 2 years after initial dose of study treatment..” The retrieved endpoint description is: To characterize the safety and tolerability of mezigdomide in combination with ziftomenib, all reported toxicities will be summarized by toxicity type and maximum grade and will be reported as numbers and percentages. All participants who receive at least one dose of study treatments will be evaluable for toxicity..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 24 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Acute myeloid leukaemia with 11q23 abnormality. These records do not establish direct evidence for NCT07355335 unless the registration number matches.
A Phase 1/2a, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety and Efficacy of GDX012 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1/2; n=16; Number of Participants With Dose Limiting Toxicities (DLTs) to Determine the Maximum Tolerated Dose (MTD) of GDX012 = 0 Participants ; Number of Participants With Dose Limiting Toxicities (DLTs) to Determine the Maximum Tolerated Dose (MTD) of GDX012 = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05886491
Vyxeos for Induction of Newly Diagnosed Low- or Intermediate-risk AML Patients, Age 18-70. A Pilot Study
Phase 2; n=20; Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg. = 6 Participants ; Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg. = 13 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05599360
Dordaviprone Maintenance After Allogeneic HCT for High‐Risk Acute Myeloid Leukemia and Myelodysplastic Neoplasm
Phase 1; n=20; AE(Grade ≥ 3) = 45.0 % Source: https://pubmed.ncbi.nlm.nih.gov/42359621/
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Ziftomenib is indexed as Small molecule drug with MLL1 x menin biology and a global stage of Approved. The asset profile lists Kura Oncology, Inc. as an originator or developer.
The Massachusetts General Hospital is indexed in United States with the website http://www.massgeneral.org. Massachusetts General Hospital is a primary teaching hospital of Harvard Medical School and a biomedical research facility. The record lists 30 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Ziftomenib is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07355335
Protocol source: https://clinicaltrials.gov/study/NCT07355335
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
Ziftomenib in Acute myeloid leukaemia with 11q23 abnormality is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] and 2027-07-01 the leading decision points.
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