NCT07703436 DS-1001 IDH1-mutant Glioma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Move from a broad disease map to a decision-ready trial dossier. This focused report examines NCT07703436—Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease—using PatSnap Clinical Trials, Drug & Asset, and Company & Deal Intelligence MCP evidence. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.
MCP evidence snapshot: 16 July 2026; publication date: 17 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.
Why NCT07703436 is a hot trial to watch
IDH1-mutant Glioma is increasingly segmented by mechanism, biomarker, line of therapy, geography and endpoint architecture. NCT07703436 is notable because it tests DS-1001 in a Phase 2 design while Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR) serves as the main decision variable. The value of this program will depend on whether the protocol converts biological rationale into a clinically interpretable and operationally credible readout.
PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add mechanism, development-status and sponsor context.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07703436 |
| Official title | Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | DS-1001 |
| Sponsor | Nuvation Bio, Inc. |
| Geography | Not reported |
| Enrollment | 40 |
| Primary endpoint | Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR) |
| Endpoint time frame | From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months |
| Primary completion / readout proxy | 2030-09-01 |
Design and endpoint interpretation
The design should be read as an evidence architecture, not just a phase label. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Enrollment of 40 participants across the reported study geography shapes statistical precision, execution risk and external validity. A strong readout will need to be interpreted against baseline risk, prior treatment, assessment schedule, missing-data handling and the clinical relevance of the observed effect.
- Primary: Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR) — From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
- Secondary: ORR per modified RANO 2.0 assessed by Investigator — From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
- Secondary: Volumetric Tumor Growth Rate (TGR) by BICR — From historical scans through the final scan in the study, approximately 18 months
- Secondary: Duration of Response (DOR) per modified RANO 2.0 assessed by BICR and by Investigator — From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
- Secondary: Time to Next Intervention (TTNI) — From the date of first dose of study drug until the date of the start of another anticancer treatment or date of death, approximately 18 months
Benchmark readouts in the surrounding field
- Osimertinib after definitive CRT in unresectable stage III EGFR-mutated NSCLC: safety outcomes from the phase III LAURA study (Phase 3): AE(led to discontinuation) = 5.0 % ; AE(led to discontinuation) = 13.0 %
- A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201) (Phase 2): Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) = 26.8 percentage of participants (95% Confidence Interval, 14.2 - 42.9)
- A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer (Phase 3): OS(Median) = 13.7 months (95% Confidence Interval, 11.2 - 16.2); OS(Median): Hazard Ratio (HR) = 0.661(95% CI, 0.553 - 0.790), P-Value = <0.0001
These indexed results are contextual benchmarks rather than direct head-to-head evidence. Cross-trial comparisons can be distorted by population, treatment line, endpoint definition, follow-up and analysis set. Their value is to clarify what magnitude and type of evidence the market already recognizes.
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Asset and sponsor context
Drug & Asset context: DS-1001 (Phase 3; IDH1)
Company & Deal Intelligence context: Nuvation Bio, Inc. — http://www.nuvationbio.com
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes that connect activity with function, symptoms, survival or treatment burden.
- Sequencing evidence: comparative data after the most relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment status, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. The most important inflection point is not always the headline data release; a change in endpoint, population or ownership can alter probability of success months earlier.
Bottom line
NCT07703436 is a focused lens on IDH1-mutant Glioma development. Its value will be determined by whether DS-1001 can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from existing benchmark readouts.
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