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Not yet recruitingNCT07899632Updated Oct 27, 2026

A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors

A Phase 1/2 interventional study of MDSY-1240 in Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC) and Gastric Cancer Adenocarcinoma Metastatic, sponsored by Medsyn Biopharma, LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Medsyn Biopharma, LLC · Phase 1/2, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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
Read the detailed description

The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of an investigational drug, MDSY-1240, in participants with certain blood cancers and advanced solid tumors. MDSY-1240 is designed to target and degrade STAT3, a protein that may be overactive in many types of cancer and can help cancer cells grow, survive, and evade the body's natural immune response. By lowering STAT3 levels, MDSY-1240 may help slow or stop cancer growth.

Researchers will use this study to determine the most appropriate dose of the MDSY-1240, understand how the drug is processed by the body, and evaluate its effects on STAT3 and related biological pathways. The study will also assess the treatment's effects on STAT3 and explore whether it demonstrates preliminary anti-cancer activity, including disease control, tumor response, and progression outcomes.

02

Conditions studied

  • 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

Keywords

  • STAT3 pathway activation
  • STAT3 mutation-positive tumors
  • Hematologic Malignancies
  • Advanced Solid Tumors
03

In context

Triple Negative Breast Neoplasms

1,165 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.

This study's planned enrollment of 75 is above the median of 61 across 1,002 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Medsyn Biopharma, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    MDSY-1240 Dose Escalation

    Participants will receive escalating doses of MDSY-1240 in 28-day treatment cycles to evaluate safety and tolerability and support selection of the recommended Phase 2 dose (RP2D). Up to 50 participants may be enrolled in this dose-escalation arm.

    Drug: MDSY-1240

  • Experimental
    MDSY-1240 Dose Expansion

    Participants will receive MDSY-1240 at the selected dose in 28-day treatment cycles to evaluate antitumor activity and further characterize safety in relapsed/refractory hematologic malignancies. Up to 25 participants may be enrolled in this dose-expansion arm.

    Drug: MDSY-1240

Interventions

  • DrugMDSY-1240

    Participants will receive MDSY-1240 Intravenously (IV) on days 1, 8, 15, and 22 in a 28-day cycle.

06

What researchers measure

Primary outcomes

  1. Part 1 (Dose Escalation): Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days.

  2. Part 1 (Dose Escalation): Number of Participants With Serious Adverse Events (SAEs)

    Time frame: From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days

  3. Part 1 (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs)

    Time frame: From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days

  4. Part 1 (Dose Escalation): Number of Participants With Treatment-Related Adverse Events (TRAEs)

    Time frame: From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days

  5. Part 1 (Dose Escalation): Number of Participants With Dose Interruptions Due to Adverse Events

    Time frame: From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days

  6. Part 1 (Dose Escalation): Number of Participants With Treatment Discontinuations Due to Adverse Events

    Time frame: From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days

  7. Part 1 (Dose Escalation): Number of Participants With Infusion-Related Reactions (IRRs)

    Time frame: From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days

  8. Part 1 (Dose Escalation): Number of Participants With Dose-Limiting Toxicities (DLTs)

    Time frame: During the Dose-Limiting Toxicity (DLT) evaluation period from Cycle 1 Day 1 through Day 22 of Cycle 1.

Secondary outcomes

  1. Part 1 (Dose Escalation): Maximum Observed Plasma Concentration (Cmax) of MDSY-1240

    Time frame: PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1.

  2. Part 1 (Dose Escalation): Time to Maximum Plasma Concentration (Tmax) of MDSY-1240

    Time frame: PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1.

  3. Part 1 (Dose Escalation): Terminal Elimination Half-Life (t½) of MDSY-1240

    Time frame: PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1.

  4. Part 1 (Dose Escalation): Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of MDSY-1240

    Time frame: PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1.

  5. Part 1 (Dose Escalation): Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of MDSY-1240

    Time frame: PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1.

  6. Part 1 (Dose Escalation): Apparent Clearance (CL) of MDSY-1240

    Time frame: PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1.

  7. Part 1 (Dose Escalation): Volume of Distribution at Steady State (Vss) of MDSY-1240

    Time frame: PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1.

  8. Part 1 (Dose Escalation): Change From Baseline in Total STAT3 Protein Levels in PBMCs

    Time frame: From informed consent (Cycle 0 Day -28) through the end of Cycle 2 (each cycle is 28 days).

  9. Part 1 (Dose Escalation): Change From Baseline in Phosphorylated STAT3 (pSTAT3) Protein Levels in PBMCs

    Time frame: From informed consent (Cycle 0 Day -28) through the end of Cycle 2 (each cycle is 28 days).

  10. Part 1 (Dose Escalation): Time to Response (TTR) according to disease-specific response criteria

    Time frame: Through study completion, an average of 24 months

  11. Clinical Benefit Rate (CBR) according to disease-specific response criteria

    Time frame: Through study completion, an average of 24 months

  12. Objective Response Rate (ORR) according to disease-specific response criteria.

    Time frame: From first dose through disease assessments, up to approximately 24 months

  13. Duration of Response (DoR) according to disease-specific response criteria.

    Time frame: Through study completion, an average of 24 months

  14. Progression Free Survival (PFS) according to disease-specific response criteria.

    Time frame: Through study completion, an average of 24 months

  15. Overall Survival (OS) in Participants With Relapsed/Refractory Hematologic Malignancies

    Time frame: Through study completion, an average of 24 months

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Aug 2029, 33 months later.

Of 68 industry-sponsored phase 1/2 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 75. This study's planned 33 months is below that.

Counting every sponsor, half of 113 studies reached it within 62 months; a quarter within 46 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Oct 27, 2026
StartEst.
Nov 2026
Primary completionEst.
Aug 2029
CompletionEst.
Sep 2029
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07899632
Lead sponsor
Medsyn Biopharma, LLC
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Nov 2026 (estimated)
Primary completion
Aug 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Mel Sorensen, MD
Contact
Mel@medsynbio.com
(610) 209-8885
Krish Patel, MD
study chair · SCRI Development Innovations, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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