{ "data": { "asOf": "2026-10-30T22:26:31.535Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07899632", "title": "A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors", "scientificTitle": "An Open-Label, Single-Arm, Multicenter, Dose-Escalation and Dose-Expansion Phase 1/2I/II Study for the Safety, Tolerability and Preliminary Efficacy of MDSY-1240, a STAT3 Degrader, in Participants With Hematologic Malignancies and Advanced Solid Tumors", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [ "PHASE1", "PHASE2" ], "conditions": [ "Triple-Negative Breast Cancer (TNBC)", "Gastric Cancer (GC)", "Gastric Cancer Adenocarcinoma Metastatic", "Ovarian Cancer Metastatic", "Ovarian Cancer Metastatic Recurrent", "Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)", "Hepatocellular Carcinoma Metastatic", "Classical Hodgkin Lymphoma Relapsed", "Cutaneous T-Cell Lymphoma/Mycosis Fungoides", "Cutaneous T-Cell Lymphoma/Sezary Syndrome", "Cutaneous T-Cell Lymphomas", "Peripheral T-cell Lymphoma (PTCL)", "Large Granular Lymphocytic Leukemia (LGL-L)", "T-Cell Large Granular Lymphocytic Leukemia" ], "interventions": [ { "name": "MDSY-1240", "type": "DRUG", "description": "Participants will receive MDSY-1240 Intravenously (IV) on days 1, 8, 15, and 22 in a 28-day cycle." } ], "sponsor": { "name": "Medsyn Biopharma, LLC", "type": "INDUSTRY" }, "locations": [], "outcomes": { "other": [], "primary": [ "Part 1 (Dose Escalation): Number of Participants With Treatment-Emergent Adverse Events (TEAEs)", "Part 1 (Dose Escalation): Number of Participants With Serious Adverse Events (SAEs)", "Part 1 (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs)", "Part 1 (Dose Escalation): Number of Participants With Treatment-Related Adverse Events (TRAEs)", "Part 1 (Dose Escalation): Number of Participants With Dose Interruptions Due to Adverse Events", "Part 1 (Dose Escalation): Number of Participants With Treatment Discontinuations Due to Adverse Events", "Part 1 (Dose Escalation): Number of Participants With Infusion-Related Reactions (IRRs)", "Part 1 (Dose Escalation): Number of Participants With Dose-Limiting Toxicities (DLTs)" ], "secondary": [ "Part 1 (Dose Escalation): Maximum Observed Plasma Concentration (Cmax) of MDSY-1240", "Part 1 (Dose Escalation): Time to Maximum Plasma Concentration (Tmax) of MDSY-1240", "Part 1 (Dose Escalation): Terminal Elimination Half-Life (t½) of MDSY-1240", "Part 1 (Dose Escalation): Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of MDSY-1240", "Part 1 (Dose Escalation): Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of MDSY-1240", "Part 1 (Dose Escalation): Apparent Clearance (CL) of MDSY-1240", "Part 1 (Dose Escalation): Volume of Distribution at Steady State (Vss) of MDSY-1240", "Part 1 (Dose Escalation): Change From Baseline in Total STAT3 Protein Levels in PBMCs", "Part 1 (Dose Escalation): Change From Baseline in Phosphorylated STAT3 (pSTAT3) Protein Levels in PBMCs", "Part 1 (Dose Escalation): Time to Response (TTR) according to disease-specific response criteria", "Clinical Benefit Rate (CBR) according to disease-specific response criteria", "Objective Response Rate (ORR) according to disease-specific response criteria.", "Duration of Response (DoR) according to disease-specific response criteria.", "Progression Free Survival (PFS) according to disease-specific response criteria.", "Overall Survival (OS) in Participants With Relapsed/Refractory Hematologic Malignancies" ] }, "eligibility": { "sex": "ALL", "criteria": "General Inclusion Criteria:\n\n* ECOG 0-2\n* Has a histologically or cytologically confirmed malignancy meeting one of the protocol-defined disease-specific eligibility criteria below:\n* Part 1: PTCL, CTCL, T-cell LGL, cHL, and DLBCL (non-GCB): Relapsed/refractory disease meeting disease-specific prior treatment requirements.\n* T-cell LGL: Must also have treatment-requiring anemia and/or neutropenia.\n* Advanced solid tumors: No standard therapy expected to provide clinical benefit, with or without STAT3 pathway activation.\n* Part 2: cHL: Relapsed/refractory after brentuximab vedotin and an immune checkpoint inhibitor.\n* PTCL/CTCL: Relapsed/refractory after ≥1 prior systemic therapy (ALCL requires prior brentuximab vedotin).\n\nGeneral Exclusion Criteria:\n\n* Prior treatment with a STAT3 degrader (unless permitted in a specific cohort).\n* Recent stem cell transplant (allogeneic within 90 days; autologous within 60 days), active GvHD, or CAR-T therapy within 30 days.\n* Use of prohibited medications, including warfarin, QT-prolonging agents, or certain CYP3A/CYP2C8/CYP2C9-interacting drugs.\n* Active gastrointestinal disease that may affect drug absorption or tolerability (eg, Crohn's disease, ulcerative colitis, peptic ulcer disease, diverticulitis, uncontrolled vomiting, or diarrhea).\n* Active, untreated, or unstable CNS involvement (brain metastases, leptomeningeal disease, or spinal cord compression).\n* Clinically significant cardiovascular disease, including recent arterial thrombotic events, uncontrolled hypertension, heart failure, significant ECG abnormalities, prolonged QTc, or reduced LVEF.\n* Active uncontrolled infection, uncontrolled autoimmune disease, or chronic corticosteroid use \\>10 mg/day prednisone equivalent.\n* Other active malignancies requiring treatment.\n* Uncontrolled HBV, HCV, or HIV infection not meeting protocol-defined requirements.", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 75 }, "startDate": "2026-11-01", "completionDate": "2029-09-01", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2026-10-27T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07899632" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07899632", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07899632", "sourceUrl": "https://clinicaltrials.gov/study/NCT07899632", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:19.309Z", "payloadSha256": "f5d8d394c2e212d5b3356ae977608c089c6cfd0ed61c806b9ba02d9652d6e77b", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07899632", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07899632", "verifyAt": "https://clinicaltrials.gov/study/NCT07899632", "retrievedAt": "2026-10-28T04:32:19.309Z", "payloadSha256": "f5d8d394c2e212d5b3356ae977608c089c6cfd0ed61c806b9ba02d9652d6e77b", "text": "ClinicalTrials.gov, record NCT07899632 (https://clinicaltrials.gov/study/NCT07899632), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07899632, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_s8XgAVYjGAac", "generatedAt": "2026-10-30T22:26:31.535Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }