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Advanced Solid TumorsPhase 1/2NCT07744763

A Phase I/IIa Study of SYS6041 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing SYS6041 in people with Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I/IIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SYS6041
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteChina
Study dates
28 Mar 2025to 31 Mar 2027
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

Who may be able to join

  • Aged >= 18 years.
  • The expected survival time is >=3 months.
  • Eastern Cooperative Oncology Group (ECOG) 0~1.
  • Willing to provide recent tumor tissue specimens for FRα testing.
  • At least one measurable lesion as defined by RECIST Version 1.1.
  • The organ function level and related laboratory indicators must meet requirement.
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  • 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.
  • Additional inclusion criteria for the expansion cohort stage: Radiological and/or pathological progression or intolerance to the most recent systemic anti-tumor therapy.
  • 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.
  • 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.

Who cannot join

  • Known severe allergic reaction to the study drug or any other components/excipients in the formulation.
  • Untreated (including those identified at baseline screening) or unstable parenchymal brain metastases, spinal metastases or spinal cord compression, carcinomatous meningitis.
  • History of other malignant tumors within 3 years, or concurrent active malignant tumors.
  • Prior treatment with ADCs carrying topoisomerase I inhibitor payloads.
  • Adverse reactions from prior anti-tumor therapies have not recovered to Grade ≤1 per CTCAE v5.0.
  • 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.
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  • 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.
  • 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.
  • Severe chronic or active infections requiring intravenous antibacterial, antifungal or antiviral therapy within 14 days prior to the first dose (including tuberculous infection, etc.).
  • Subjects receiving long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy.
  • Uncontrolled serous cavity effusions requiring frequent drainage or medical intervention within 7 days prior to the first dose.
  • Presence of risk factors for intestinal obstruction or intestinal perforation.
  • Grade ≥2 severe diarrhea per CTCAE within 7 days prior to the first dose.
  • 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.
  • History of severe cardiovascular diseases.
  • Female subjects who are pregnant or breastfeeding.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

031169085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

  • Xiaohua

    Shanghai, Shanghai Municipality, 200032

    Xiaohua Wu, Ph.D, 181 2129 9168, wu.xh@fudan.edu.cn

    Jian Zhang

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label, Dose-escalation and Dose-expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Antitumor Activity of SYS6041 in Patients With Advanced Solid Tumors

This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I/IIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced solid tumors.

Read the detailed description

The trial consists of four stages: Phase I dose-escalation stage, as well as Phase IIa dose-reassignment stage, dose-expansion stage and cohort-expansion stage.

The dose-escalation stage includes a screening period (28 days), a treatment period (DLT observation period and subsequent treatment period), and a follow-up period (safety follow-up and survival follow-up). The first cycle (21 days) in which participants receive SYS6041 administration is defined as the DLT observation period.

Based on data obtained from the dose-escalation and dose-reassignment stages, two dose levels will be selected for randomized enrollment in the dose-expansion stage to further assess the efficacy, safety and pharmacokinetic (PK) profile of candidate doses and confirm the recommended Phase 2 dose (RP2D).

The cohort-expansion stage comprises a screening period (28 days), a treatment period and a follow-up period (safety follow-up and survival follow-up). Eligible screened participants will receive intravenous infusion of SYS6041 on Day 1 of each cycle, with each treatment cycle lasting 3 weeks. Treatment will be discontinued upon the first occurrence of progressive disease (PD), intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or any other conditions meeting the treatment discontinuation criteria.

Being tested
SYS6041

What participants receive

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

  • SYS6041Drug

    Farletuzumab-exatecan antibody-drug conjugate targeting human FRα

Study groups in NCT07744763
Study groupRoleWhat they receive
SYS6041Experimentalintravenous injection
Receives: Drug: SYS6041

What is being measured

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

  1. Dose limiting toxicity (DLT)

    Incidence of DLT (Applicable only to the Phase I dose-escalation stage)

    Measured: 21 days

  2. ORR

    ORR assessed by investigators per RECIST 1.1

    Measured: Through study completion，up to 2 years.

Secondary outcomes (6)

  1. Number of participants with Adverse events (AEs)

    Safety assessments

    Measured: Up to 2 years

  2. DCR

    During follow-up

    Measured: Up to 2 years

  3. Progression-free survival（PFS）

    During follow-up

    Measured: Up to 2 years

  4. Overall survival (OS)

    During follow-up

    Measured: Up to 2 years

  5. PK parameters

    Time to maximum observed concentration(T-max)

    Measured: Up to 2 years

  6. Immunogenicity

    Incidence of anti-drug antibodies (ADA)

    Measured: Up to 2 years

Timeline

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

  1. First posted4 Aug 2026
  2. Study start28 Mar 2025
  3. Primary completion28 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (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
Single group
Model description
This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I/IIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced solid tumors. The trial consists of four stages: Phase I dose-escalation stage, as well as Phase IIa dose-reassignment stage, dose-expansion stage and cohort-expansion stage.
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07744763
Sponsor's protocol ID
SYS6041-001
Status last verified
Jul 2026
First submitted
29 Jul 2026
Last updated
4 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SYS6041 in people with Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.

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

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: 21 days). The study lists 2 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 NCT07744763.

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 4 Aug 2026.

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