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Can a smart drug deliver a direct hit to Hard-to-Treat tumors?

NCT ID NCT07744763

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial is testing an experimental drug called SYS6041 in people with advanced solid tumors. SYS6041 is designed to seek out and attach to a protein called FRα that is found on some cancer cells, delivering a potent anti-cancer agent directly to the tumor. The study aims to find the safest dose and see whether the drug can shrink tumors. It is open to adults with advanced solid tumors who have at least one measurable lesion and are willing to provide a tumor sample for testing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SYS6041, an antibody-drug conjugate that targets a protein called FRα found on some tumor cells, delivering a chemotherapy-like drug directly to the cancer.
What this could lead to
If successful, this could lead to a new targeted treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early-stage trial, so the drug may not be safe or effective in humans. Potential risks include side effects from the chemotherapy component and the possibility that the tumor does not respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged \>= 18 years. 2. The expected survival time is \>=3 months. 3. Eastern Cooperative Oncology Group (ECOG) 0\~1. 4. Willing to provide recent tumor tissue specimens for FRα testing. 5. At least one measurable lesion as defined by RECIST Version 1.1. 6. The organ function level and related laboratory indicators must meet requirement. 7. Additional inclusion criteria for the dose-escalation stage: Histologically or cytologically confirmed unresectable locally advanced or metastatic ovarian cancer, endometrial cancer, NSCLC, or breast cancer with disease progression following standard therapy. 8. Additional inclusion criteria for the expansion cohort stage: Radiological and/or pathological progression or intolerance to the most recent systemic anti-tumor therapy. 9. Additional inclusion criteria for the expansion cohort stage: Histologically or cytologically confirmed advanced solid tumors, including ovarian cancer, endometrial cancer, or other FRα-positive solid tumors that have received at least one prior line of systemic therapy. 10. Agree to use reliable and effective methods of contraception during the study treatment period and for at least 5 months (for male subjects) or 8 months (for female subjects) after the last study treatment. Exclusion Criteria: 1. Known severe allergic reaction to the study drug or any other components/excipients in the formulation. 2. Untreated (including those identified at baseline screening) or unstable parenchymal brain metastases, spinal metastases or spinal cord compression, carcinomatous meningitis. 3. History of other malignant tumors within 3 years, or concurrent active malignant tumors. 4. Prior treatment with ADCs carrying topoisomerase I inhibitor payloads. 5. Adverse reactions from prior anti-tumor therapies have not recovered to Grade ≤1 per CTCAE v5.0. 6. Received immunotherapy, macromolecular targeted therapy or other anti-tumor biotherapy within 4 weeks prior to the first dose; or received endocrine therapy, cytotoxic chemotherapy, small-molecule targeted therapy within 2 weeks prior to the first dose; or received traditional Chinese medicinal preparations with anti-tumor indications within 2 weeks prior to the first dose. 7. Patients who have undergone major organ surgery within 28 days prior to the first dose, or have planned systemic or local tumor resection during the study period. 8. Patients who have received strong CYP3A4 inhibitors or strong CYP3A4 inducers systemically within 14 days prior to the first dose, or require continuous systemic administration of such agents during study treatment. 9. Severe chronic or active infections requiring intravenous antibacterial, antifungal or antiviral therapy within 14 days prior to the first dose (including tuberculous infection, etc.). 10. Subjects receiving long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy. 11. Uncontrolled serous cavity effusions requiring frequent drainage or medical intervention within 7 days prior to the first dose. 12. Presence of risk factors for intestinal obstruction or intestinal perforation. 13. Grade ≥2 severe diarrhea per CTCAE within 7 days prior to the first dose. 14. History of non-infectious lung disease/pneumonitis requiring steroid therapy, or current interstitial lung disease/pneumonitis, or suspected such diseases identified by imaging examinations during screening. 15. History of severe cardiovascular diseases. 16. Female subjects who are pregnant or breastfeeding. 17. Any other circumstances that may interfere with the subject's participation in study procedures, compromise the subject's maximum benefit from study participation, or affect study results, in the Investigator's judgment.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Xiaohua

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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