AzTrials
AzTrials

Triple-Negative Breast Cancer (TNBC)Phase 1/2NCT07899632

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

A Phase 1/2 study testing MDSY-1240 in people with Triple-Negative Breast Cancer (TNBC) and Gastric Cancer (GC), run by Medsyn Biopharma, LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MDSY-1240
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
No sites listed yet
Study dates
Nov 2026to Sep 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mel Sorensen, MD contact

(610) 209-8885

Mel@medsynbio.com

About this study

Official title: 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

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.

Being tested
MDSY-1240
Keywords
STAT3 pathway activation, STAT3 mutation-positive tumors, Hematologic Malignancies, Advanced Solid Tumors
Medical subject headings
Triple Negative Breast Neoplasms, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis, Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDSY-1240Drug

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

Study groups in NCT07899632
Study groupRoleWhat they receive
MDSY-1240 Dose EscalationExperimentalParticipants 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.
Receives: Drug: MDSY-1240
MDSY-1240 Dose ExpansionExperimentalParticipants 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.
Receives: Drug: MDSY-1240

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

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

Secondary outcomes (15)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1.

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Through study completion, an average of 24 months

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

    Measured: Through study completion, an average of 24 months

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

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

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

    Measured: Through study completion, an average of 24 months

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

    Measured: Through study completion, an average of 24 months

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

    Measured: Through study completion, an average of 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionAug 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07899632
Sponsor's protocol ID
MDSY-1240-001
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MDSY-1240 in people with Triple-Negative Breast Cancer (TNBC) and Gastric Cancer (GC), run by Medsyn Biopharma, LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mel Sorensen, MD ((610) 209-8885, Mel@medsynbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07899632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in