NCT07899632Not yet recruitingPhase 1/2
A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
This clinical trial is evaluating a drug called MDSY-2140 in participants with hematologic malignancies and advanced solid tumors. The main goals of this study are to: * Find the recommended dose of MDSY-1240 that can be safely given to participants * Learn more about the side effects and effectiveness of MDSY-1240
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Aug 2029
- Lead sponsor
- Medsyn Biopharma, LLC
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07899632
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 75
- From Nov 2026 to the primary completion date, Aug 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- General Inclusion Criteria:
- ECOG 0-2
- Has a histologically or cytologically confirmed malignancy meeting one of the protocol-defined disease-specific eligibility criteria below:
- Part 1: PTCL, CTCL, T-cell LGL, cHL, and DLBCL (non-GCB): Relapsed/refractory disease meeting disease-specific prior treatment requirements.
- T-cell LGL: Must also have treatment-requiring anemia and/or neutropenia.
- Advanced solid tumors: No standard therapy expected to provide clinical benefit, with or without STAT3 pathway activation.
- Part 2: cHL: Relapsed/refractory after brentuximab vedotin and an immune checkpoint inhibitor.
- PTCL/CTCL: Relapsed/refractory after ≥1 prior systemic therapy (ALCL requires prior brentuximab vedotin).
- General Exclusion Criteria:
- Prior treatment with a STAT3 degrader (unless permitted in a specific cohort).
- Recent stem cell transplant (allogeneic within 90 days; autologous within 60 days), active GvHD, or CAR-T therapy within 30 days.
- Use of prohibited medications, including warfarin, QT-prolonging agents, or certain CYP3A/CYP2C8/CYP2C9-interacting drugs.
- Active gastrointestinal disease that may affect drug absorption or tolerability (eg, Crohn's disease, ulcerative colitis, peptic ulcer disease, diverticulitis, uncontrolled vomiting, or diarrhea).
- Active, untreated, or unstable CNS involvement (brain metastases, leptomeningeal disease, or spinal cord compression).
- Clinically significant cardiovascular disease, including recent arterial thrombotic events, uncontrolled hypertension, heart failure, significant ECG abnormalities, prolonged QTc, or reduced LVEF.
- Active uncontrolled infection, uncontrolled autoimmune disease, or chronic corticosteroid use \>10 mg/day prednisone equivalent.
- Other active malignancies requiring treatment.
- Uncontrolled HBV, HCV, or HIV infection not meeting protocol-defined requirements.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.