ISM-6331 in Mesothelioma, Malignant: NCT06566079 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: 16 September 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
100
Planned enrollment
2027-08-31
Primary-completion proxy
Executive view
NCT06566079 evaluates ISM-6331 in Mesothelioma, Malignant. The disclosed sponsor is InSilico Medicine Hong Kong Ltd., the design is Interventional, and the geographic footprint is United States, China. The first listed primary endpoint is Incidence of dose-limiting toxicity (DLT)., assessed over Day 1 up to Day 31.
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 NCT06566079 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Mesothelioma, Malignant landscape. Drug & Asset MCP drug_fetch was queried for ISM-6331, while Company & Deal Intelligence MCP organization_fetch was queried for InSilico Medicine Hong Kong 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 |
|---|---|---|---|---|---|---|
| NCT06566079 | ISM-6331 | Phase 1 / Recruiting | InSilico Medicine Hong Kong Ltd. | United States, China | Incidence of dose-limiting toxicity (DLT). Day 1 up to Day 31 | 2027-08-31 |
| NCT07131345 | Iparomlimab/Tuvonralimab | Phase 1/2 / Not yet recruiting | Sponsor not reported | Geography not reported | ORR From enrollment to the end of treatment at 8 weeks | 2026-10-31 |
| NCT06885697 | Fludarabine Phosphate | Phase 1 / Recruiting | National Cancer Institute | United States | Establish the recommended phase 2 dose (RP2D) of TNhYP218 CAR T cells based on dose-limiting toxicity (DLT) of defined… DLT assessment will occur in participants in the dose escalation coho… | 2034-06-01 |
| NCT06875076 | Ivonescimab | Phase 2 / Recruiting | The First Hospital of Jilin University | China | objective response rate (ORR) From enrollment to the end of treatment at 3 months | 2028-01-01 |
| NCT06840834 | Ivonescimab | Phase 2 / Recruiting | Intergroupe Francophone Cancerologie Thoracique | France | To assess the therapeutic value of the bispecific antibody anti-VEGF / anti-PD-1 ivonescimab as 2nd/3rd line treatment… 12 weeks after start of treatment. | 2026-09-30 |
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
NCT06566079 is a Phase 1, recruiting study with 100 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment.
The primary endpoint is “Incidence of dose-limiting toxicity (DLT).” over “Day 1 up to Day 31.” The retrieved endpoint description is: DLT is defined as any adverse event which meets DLT criteria unless it is clearly related to disease progression or intercurrent illness during the first 31 days after the initiation of treatment in the dose escalation part (Part 1)..
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 100 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 Mesothelioma, Malignant. These records do not establish direct evidence for NCT06566079 unless the registration number matches.
First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-Term PFS and OS
Phase 2; n=31; OS(24-month) = 25.0 % ; OS(24-month) = 50.7 % Source: https://cattendee.abstractsonline.com/meeting/21487/Session/133
Phase II Trial of Olaparib in Patients With Mesothelioma
Phase 2; n=34; ORR = 3.0 % Source: https://cattendee.abstractsonline.com/meeting/21487/Session/195
Tumour Extrinsic Regulation of Neutrophils Sensitize Mesotheliomas to AXL and PD1 Inhibition inMIST3, a Phase II Clinical Trial
Phase 2; n=21; DCR(12-week) = 46.2 % ( 29.2 - 63.8) Source: https://cattendee.abstractsonline.com/meeting/21487/Session/133
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
No exact Drug & Asset MCP profile was returned for the protocol wording “ISM-6331.” The report therefore avoids inferring modality, target or global development stage from the name alone.
No exact Company & Deal Intelligence profile was returned for InSilico Medicine Hong Kong Ltd.. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
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 ISM-6331 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: NCT06566079
Protocol source: https://clinicaltrials.gov/study/NCT06566079
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: 16 September 2026.
ISM-6331 in Mesothelioma, Malignant is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence of dose-limiting toxicity (DLT). and 2027-08-31 the leading decision points.
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