Phase I Study of SYS6043 for Advanced Solid Tumors
This study is testing an investigational drug called SYS6043 in adults with advanced or metastatic (spread to other parts of the body) solid tumors. These are cancers that have returned, progressed after standard treatments, or for which standard treatments are no longer an option. SYS6043 is an antibody-drug conjugate, a type of targeted therapy. The main goals are to find a safe dose, understand any side effects, and see how the body handles the drug. Researchers will also look for early signs that SYS6043 might help shrink or slow tumor growth. You may be able to join if you are 18 or older and have advanced or metastatic solid tumors. The study is currently recruiting 386 participants.
- Study design
- This is an open-label, Phase I study, meaning you and your doctors will know you are receiving SYS6043. It involves dose escalation, PK expansion, and cohort expansion phases to evaluate the drug's safety and effectiveness.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety and tolerability will be measured for an average of 1 year.
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NCT07424547
Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentConjupro Biotherapeutics, Inc.
~386 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:SYS6043
At a glance
Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a).
Measured over An average of 1 year.
+1 more outcome measured
Conditions
Where it's being run
5 sites across 3 statesFlorida2
Texas2
Virginia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Aged ≥18 years old (on the date of signing the ICF).
Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology, disease recurrence or progression during or after systemic standard of care, and should be intolerant of or have no available standard of care therapy.
Have at least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). Participants with metastatic castration-resistant prostate cancer (mCRPC) who have only metastases to bone will be evaluated through discussion with the sponsor's medical monitor, before determining whether they can be enrolled.
Expected life expectancy of ≥ 3 months.
ECOG performance status of 0-1 and no worsening of the score within 28 days prior to enrollment.
LVEF ≥ 50% as shown by ECHO or MUGA within 28 days prior to enrollment.
Exclusion
Prior B7-H3 targeted therapy.
Previously received drug therapy with topoisomerase inhibitor antibody-drug conjugate (e.g., trastuzumab deruxtecan).
Symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class II-IV) or a history of severe arrhythmia requiring treatment.
History of myocardial infarction or unstable angina within 6 months prior to enrollment.
Based on the results of three 12-lead electrocardiogram (ECG) examinations, the mean QT interval (QTcF) corrected by the Fridericia formula for both males and females is prolonged to \>470 ms.
Unable or unwilling to discontinue concomitant medications known to prolong the QT interval.
History of interstitial lung disease (e.g., ILD/non-infectious pneumonia requiring glucocorticoid treatment in the past), or currently have interstitial lung disease, or are suspected to have such diseases through imaging examinations during screening.
History of underlying lung disorders, including but not limited to pulmonary embolism within 3 months prior to the start of study treatment, severe asthma, severe COPD, restrictive pulmonary disease, and other clinically significant lung injuries or requiring supplemental oxygen.
Any autoimmune diseases, connective tissue disorders, or inflammatory diseases involving the lungs recorded or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).
Presence of uncontrolled infection requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs.
Active and clinically significant bacterial, fungal, viral infection, or Hepatitis C infection at screening (HCV antibodies test positive and HCV-RNA levels higher than the lower limit of quantification or 1000 copies/mL (whichever is lower); HIV antibody positive or syphilis antibody positive (with confirmation)..
HBsAg positive and HBV-DNA above the lower limit of quantification or 1,000 copies/mL (500 IU/mL) (whichever is lower). Liver tumor: For participants with liver metastases and HBV infection, HBV DNA must be \<2000 IU/mL before the first dose. Participants who are HBsAg-positive and/or HBV DNA-positive should receive at least 2 weeks of anti-Hepatitis B virus treatment prior to the first dose and be willing to continue treatment during the study.
Lactating women (women who are willing to temporarily discontinue breastfeeding will also be 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 metastasis, and/or meningeal metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants.
What this trial measures
- Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a).An average of 1 year.
Assessment of the MTD and/or RP2D (recommended Phase II dose).
- Incidence of Treatment-Emergent Adverse Events and dose-limiting toxicities (DLTs) [Safety and Tolerability] of SYS6043 during the study (Phase 1a)An average 1 year
Number of participants with dose-limiting toxicities (DLTs) as assessed by NCI CTCAE v5.0