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Advanced/Metastatic Solid TumorsPhase 1/2NCT07415863

Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors

A Phase 1/2 study testing SYS6043 in people with Advanced/Metastatic 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
Search all trials

Trial summary

Phase I/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors This study is a first-in-human phase I/II, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Advanced/Metastatic Solid Tumors
What is being tested?
SYS6043
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
820 participants
Where
1 siteChina
Study dates
30 Dec 2024to 30 Jun 2028
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years inclusive (based on the date of signing the informed consent form). For Cohort 2 and Cohort 10, subjects over 75 years of age are eligible for enrollment.
  • Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumors with disease recurrence or progression during or after standard systemic therapy, intolerance to standard therapy, or no available standard therapy.
  • At least one extracranial measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). For participants with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases only, eligibility for enrollment will be determined following a discussion and assessment with the sponsor's medical monitor on a case-by-case basis.
  • Expected survival of the participant is ≥ 3 months.
  • ECOG performance status of 0 or 1 with no deterioration in status identified within 28 days prior to enrollment. For Cohort 2 and Cohort 10, subjects with an ECOG performance status of 2 are eligible for enrollment.
  • Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or radionuclide ventriculography (MUGA) within 28 days prior to enrollment.
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  • Adequate function of major organs meeting the following requirements within 7 days prior to enrollment:
  • Hematology (no receipt of whole blood, red blood cell or platelet transfusion, and no administration of hematopoietic stimulating factors [G-CSF or GM-CSF], erythropoietin [EPO] or thrombopoietin [TPO] for cytorection within 7 days prior to sample collection):Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L;Platelet count (PLT) ≥ 100×10⁹/L;Hemoglobin (HGB) ≥ 90 g/L.
  • Blood biochemistry:Serum creatinine ≤ 1.5×upper limit of normal (ULN);Serum total bilirubin (TBIL) ≤ 1.5×ULN (may be relaxed to 3×ULN for participants with Gilbert's syndrome);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5.0×ULN for participants with hepatocellular carcinoma or liver metastases);Serum albumin ≥ 30 g/L.
  • Coagulation function:Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (for participants not receiving anticoagulant therapy); for participants receiving anticoagulant therapy, indices shall be within the therapeutic target range with a stable dosage.
  • Toxic reactions caused by any prior therapy have recovered to ≤ Grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or baseline levels (except for alopecia, fatigue, peripheral neuropathy and other toxicities that the investigator deems to pose no safety risk to the participant).
  • Sufficient washout period for prior anti-tumor therapies before the first study drug administration.
  • Be willing to provide previously resected tumor samples or undergo a fresh tumor biopsy for the detection of B7-H3 expression levels and other biomarkers (if there are no contraindications).
  • For female participants of childbearing potential, the serum pregnancy test result within 7 days prior to randomization must be negative. Male and female participants with reproductive potential must agree to adopt adequate contraceptive measures during the study period and for at least 7 months after the last administration of the study drug; during this period, female participants must not be breastfeeding, male participants must not freeze or donate sperm, and female participants must not donate or retrieve oocytes for personal use.
  • Have a full understanding of this clinical trial and voluntarily sign a written informed consent form
  • Advanced or metastatic solid tumors with failure of standard systemic therapy

Who cannot join

  • Prior receipt of B7-H3-targeted therapy.
  • Prior receipt of irinotecan, topotecan, any other topoisomerase I inhibitors (including investigational TOP1 inhibitors), or topoisomerase inhibitor antibody-drug conjugates (e.g., trastuzumab deruxtecan). This criterion applies only to the Phase I PK expansion and Phase II cohort expansion stages.
  • A history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class II-IV) or severe cardiac arrhythmias requiring treatment.
  • A history of myocardial infarction or unstable angina within 6 months prior to enrollment.
  • A prolonged corrected mean QT interval (QTcF) using the Fredericia formula of >470 milliseconds (ms) on three 12-lead electrocardiogram (ECG) assessments, for both male and female participants.
  • Inability or unwillingness to discontinue concomitant medications known to prolong the QT interval.
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  • A history of interstitial lung disease (ILD)/non-infectious pneumonia requiring glucocorticoid therapy, current ILD/non-infectious pneumonia, or suspected such disease on imaging during screening.
  • A history of underlying pulmonary disease, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other clinically significant pulmonary impairment within 3 months prior to the start of study treatment, or the need for supplemental oxygen.
  • Any autoimmune, connective tissue, or inflammatory disease involving the lungs that is documented or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).
  • Uncontrolled infection requiring intravenous antibiotics, antiviral agents, or antifungal agents.
  • Known human immunodeficiency virus (HIV) infection, or currently active syphilis infection (i.e., positive Treponema pallidum antibody [RPR or TRUST] or syphilis requiring systemic therapy).
  • Participants with active viral hepatitis (positive hepatitis B surface antigen [HBsAg] and/or positive hepatitis B core antibody [anti-HBc] with HBV DNA ≥1000 copies/mL or 2000 IU/mL; positive hepatitis C virus [HCV] with HCV RNA above the lower limit of quantification [LLOQ] of the assay).
  • Lactating women (women willing to temporarily discontinue breastfeeding are also excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment.
  • Presence of spinal cord compression, or clinically active brain or meningeal metastases. Participants with central nervous system (CNS) metastases are eligible if: they have received prior CNS-directed therapy and have had radiological and neurological stability for at least 4 weeks before the first dose (i.e., no new or enlarging metastatic lesions on imaging, no requirement for corticosteroid therapy or maintenance of a stable or tapering dose of corticosteroids [equivalent to ≤10 mg/day prednisone], and no symptoms); or they have untreated asymptomatic CNS metastases that the investigator assesses as not requiring immediate treatment.
  • A history of multiple primary malignant neoplasms within 3 years prior to enrollment, except for: adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer); in situ disease treated with curative intent (e.g., cervical or breast carcinoma in situ); and other solid tumors treated with curative intent (e.g., superficial bladder cancer).
  • A history of substance abuse, or any other medical condition that the investigator deems may increase the safety risk to the participant or interfere with the participant's participation in or evaluation of the clinical study.
  • Receipt of strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of the study drug, or the need for continued use of such medications during the study period.
  • Known hypersensitivity to the active ingredient or excipients of the study drug.
  • Presence of pleural, pericardial, or peritoneal effusion with clinical symptoms or requiring repeated drainage.
  • Any other reason that the investigator deems the participant unsuitable for enrollment in the study

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

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Lingying Wu, MD, 13910865483, wulingying@csco.org.cn

    Recruiting

Other trials in China

About this study

Official title: Phase I/II Dose-Escalation, PK Expansion and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

Phase I/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors This study is a first-in-human phase I/II, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced/metastatic solid tumors. It consists of three parts: dose escalation, PK expansion and cohort expansion.

Being tested
SYS6043

What participants receive

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

  • SYS6043Drug

    Subcutaneous injection

Study groups in NCT07415863
Study groupRoleWhat they receive
SYS6043ExperimentalSYS6043 monotherapy
Receives: Drug: SYS6043

What is being measured

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

  1. Incidence of AE（adverse events)

    Measured: Up to 3 years

  2. Phase1：MTD（Maximum Tolerated Dose）和RP2D（recommended phase 2 dose）

    Measured: Up to 3 years

  3. PhaseII：Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.

    Measured: Up to 3 years

Secondary outcomes (8)

  1. PhaseI: Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.

    Measured: Up to 3 years

  2. Duration of Response (DOR)

    DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: Up to 3 years

  3. Disease Control Rate (DCR)

    The percentage of participants who experience a best response of CR, PR or stable disease (SD).

    Measured: Up to 3 years

  4. TTR（Time to Response）

    TTR is defined as the time from the start of randomization to the first observation of an objective tumor response

    Measured: Up to 3 years

  5. PFS

    PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.

    Measured: Up to 3 years

  6. Overrall Survival (OS)

    Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.

    Measured: Up to 3 years

  7. Anti-Drug Antibody (ADA) of SYS6043

    Measured: Up to 3 years

  8. Expression levels of B7-H3 and PD-L1 proteins and tumor-associated gene variations

    Measured: Up to 3 years

Timeline

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

  1. First posted17 Feb 2026
  2. Study start30 Dec 2024
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (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
Non-randomised
Intervention model
Single group
Model description
SYS6043 monotherapy
Masking
None (open label)
Enrolment
820 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07415863
Sponsor's protocol ID
SYS6043-001
Status last verified
Feb 2026
First submitted
3 Feb 2026
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
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 SYS6043 in people with Advanced/Metastatic 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 16 inclusion and 20 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 17 Feb 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?

Incidence of AE（adverse events) (time frame: Up to 3 years). The study lists 3 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 NCT07415863.

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 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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