XS-04 in Acute Myeloid Leukemia: NCT06820268 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: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Recruiting
Recruitment status
not reported
Planned enrollment
2027-11-01
Primary-completion proxy
Executive view
NCT06820268 evaluates XS-04 in Acute Myeloid Leukemia. The disclosed sponsor is Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs), assessed over At the end of C1D21(each cycle is 28 days).
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 NCT06820268 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Acute Myeloid Leukemia landscape. Drug & Asset MCP drug_fetch was queried for XS-04, while Company & Deal Intelligence MCP organization_fetch was queried for Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd..
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 |
|---|---|---|---|---|---|---|
| NCT06820268 | XS-04 | Phase 1 / Recruiting | Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. | China | The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs) At the end of C1D21(each cycle is 28 days) | 2027-11-01 |
| NCT06956092 | Glofitamab | Phase 4 / Not yet recruiting | Zhengzhou University | China | two year PFS From date of enrollment until the date of first documented progressio… | 2028-06-01 |
| NCT06940960 | JY-231 | Not Applicable / Recruiting | Affiliated Hospital of Guangdong Medical University | China | Incidence of adverse events(AE) after infusion Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24 | 2027-12-01 |
| NCT06939283 | WTX-330 | Phase 1/2 / Active, not recruiting | Werewolf Therapeutics, Inc. | United States | Incidence of Dose Limiting Toxicities (DLTs) 4 weeks | 2028-08-01 |
| NCT06935136 | Axicabtagene Ciloleucel | Not Applicable / Not yet recruiting | Sponsor not reported | China | Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators Up to 2 years | 2026-10-09 |
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
NCT06820268 is a Phase 1, recruiting study with not reported planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)” over “At the end of C1D21(each cycle is 28 days).” The retrieved endpoint description is: Safety indicators.
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 not reported 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
0 recent result records were selected as contextual evidence for Acute Myeloid Leukemia. These records do not establish direct evidence for NCT06820268 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
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
XS-04 is indexed as Small molecule drug with BTK x FLT3 x IRAK4 biology and a global stage of Phase 1. The asset profile lists NovaOnco JS Therapeutics Co., Ltd. as an originator or developer.
Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. is indexed in an unreported country. Provides industrial investment services and imports medical products The record lists 36 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 XS-04 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: NCT06820268
Protocol source: https://clinicaltrials.gov/study/NCT06820268
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: 15 October 2026.
XS-04 in Acute Myeloid Leukemia is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs) and 2027-11-01 the leading decision points.
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