Actively Recruiting
A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Anti-tumor Activity of SYS6005 in Patients With Advanced Malignant Tumor
Led by CSPC Megalith Biopharmaceutical Co.,Ltd. · Updated on 2025-05-14
132
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SYS6005, an investigational drug, in adults with advanced malignant tumors, including both solid tumors and B-cell malignancies. This Phase I, open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of SYS6005. The study includes patients who have failed standard therapies or are intolerant to them, focusing on determining the maximum tolerated dose and recommended Phase 2 dose of SYS6005. The study consists of two phases: a dose-escalation phase using an accelerated titration design across seven dose levels with 21-day cycles, and a dose-expansion phase where selected doses and tumor types are further explored. Participants receive SYS6005 intravenously on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. Dose adjustments are guided by a Safety Monitoring Committee. Participants will undergo safety monitoring including adverse event reporting, laboratory tests, and performance status evaluations. Efficacy is assessed using imaging studies. Blood samples are collected to study pharmacokinetics and immune responses, including anti-drug antibodies. Survival is followed quarterly until death or study completion. The study may last up to 12 months or longer depending on treatment duration and follow-up needs.
CONDITIONS
Brief Title
Evaluation of SYS6005 in Patients With Advanced Malignant Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily enrolled and signed informed consent
- Adults aged 18 years or older, male or female
- Confirmed advanced malignant tumors with progression after standard therapy or intolerance to it
- Solid tumors with at least one evaluable lesion per RECIST v1.1 or B-cell malignancies confirmed by pathology with evaluable disease
- ECOG performance status of 0 to 2
- Expected survival of at least 3 months
- Adequate organ function and no recent supportive treatments within 14 days prior to examination
- For dose-expansion phase, tumor tissue must test positive for ROR1
- Agreement to use effective contraception during and for 6 months after treatment
- Willingness and ability to comply with study visits, treatment, and procedures
You will not qualify if you...
- Prior participation in studies with ROR1-targeted therapies or ADC treatments containing MMAE
- Symptomatic, untreated, or active CNS lymphoma or metastases, except stable or resected cases as defined
- Eligible for CAR-T therapy or hematopoietic stem cell transplant, or recent receipt of these treatments within specified timeframes
- History of second active malignancy within 3 years except certain cured cancers
- Immunodeficiency, active autoimmune disease, or need for high-dose systemic steroids
- Significant edema, effusions, or ascites requiring medical intervention
- Recent serious cardiac events or QTcF > 450 ms in screening ECGs
- Active infections needing treatment within 2 weeks prior to treatment
- Recent use or expected need for strong CYP3A4 inhibitors or inducers
- Unresolved toxicities from prior treatments above grade 1 except specific exceptions
- Peripheral neuropathy grade 2 or higher at baseline
- Recent major surgery, radiotherapy, targeted therapy, immunotherapy, or certain herbal medicines
- Positive HIV test or active hepatitis B or C infection
- Recent live vaccine within 28 days prior to treatment
- Known hypersensitivity to study drug components or monoclonal antibodies
- Pregnant or breastfeeding women
- Other conditions or situations that interfere with study participation or safety, such as mental illness or addiction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive escalating or selected doses of SYS6005 administered intravenously on Day 1 of each 21-day cycle.
Visits every 21 days for each treatment cycle
Duration - At least 30 days after last dose
Participants are monitored for safety, immunogenicity, and anti-tumor activity after treatment ends.
Follow-up visits as scheduled after treatment completion
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China, 300020
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here