SYS6043 for adults with advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label Phase I study gives SYS6043 — a B7‑H3–targeted antibody–drug conjugate — by intravenous infusion every three weeks to adults with advanced or metastatic solid tumors. The study has three parts: BOIN-design dose escalation to identify the maximum tolerated/maximum administered dose and recommended Phase II dose, a PK expansion at selected safe dose levels, and cohort expansion at the recommended dose(s) to gather additional safety and preliminary efficacy data. Investigators will collect safety and tolerability data, pharmacokinetics, immune response information, and early tumor response measurements, and will explore whether tumor B7‑H3 levels correlate with outcomes. A safety monitoring committee will continuously review safety data and guide dosing and cohort decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Major:

* 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 Criteria:

Major:

* 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.

Where it's running

• BRCR Global
  Plantation, Florida, United States Recruiting
• Florida Clinical Trials Group
  Plantation, Florida, United States Recruiting
• NEXT Oncology Austin
  Austin, Texas, United States Recruiting
• NEXT Oncology San Antonio
  San Antonio, Texas, United States Recruiting
• NEXT Oncology Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Director, Clinical Operations
• Email: clinicaltrials.gov@cspcus.com
• Phone: 609-356-0210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.