Actively Recruiting
Evaluation 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
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6005 in advanced malignancies, comprising dose-escalation and expansion phases. The escalation phase employs a BOIN design with accelerated titration across seven dose levels, featuring a 21-day DLT observation period in Cycle 1, with dose adjustments guided by a Safety Monitoring Committee. In the expansion phase, one or more dosing regimens and tumor types will be selected, and participants will receive SYS6005 R2PD for further exploration and validation. Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria. Safety monitoring includes AEs, labs, and ECOG PS, while efficacy is assessed via imaging. PK and immunogenicity samples are collected, and survival is tracked quarterly until death or study end. The study aims to determine the maximum tolerance dose (MTD)/recommended phase 2 dose (RP2D) and characterize SYS6005's clinical profile.
CONDITIONS
Official Title
Evaluation of SYS6005 in Patients With Advanced Malignant Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily consent and enroll in the study
- Age 18 years or older, any gender
- Advanced malignant tumor confirmed by pathology, with disease progression after standard therapy or intolerance to it
- Solid tumors must be unresectable and progressed after at least one prior systemic therapy; preferred types include breast, lung, gynecologic, prostate, skin, adrenal, testicular, colon, bladder, pancreatic, gastric, kidney, cholangiocarcinoma, and esophageal cancers
- B-cell malignancies must be Hodgkin or non-Hodgkin lymphoma confirmed pathologically, with progression after at least two prior systemic therapies; preferred types include cHL, DLBCL, MCL, FL, MZL, RTL, CLL/SLL
- At least one measurable lesion per RECIST v1.1 for solid tumors or 2014 Lugano criteria for lymphoma
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Expected survival of at least 3 months
- Adequate organ function and no recent use (within 14 days) of transfusions or supportive treatments
- For dose-expansion phase, tumor must be confirmed ROR1-positive by central lab
- Participants of childbearing potential must agree to use effective contraception during and 6 months after treatment; females must have a negative pregnancy test within 7 days before treatment
- Willing and able to comply with all study procedures and visits
You will not qualify if you...
- Prior participation in studies involving ROR1-targeted therapies or previous treatment with ADCs containing MMAE
- Known symptomatic, untreated, or actively treated CNS lymphoma or CNS metastases, except stable or resected metastases without brain edema or corticosteroid use
- Candidates for CAR-T therapy or stem cell transplant; recent allogeneic transplant within 6 months, autologous transplant within 100 days, or CAR-T therapy within 3 months; active graft versus host disease
- History of second active malignancy within 3 years except certain cured local cancers
- Immunodeficiency, active autoimmune diseases requiring systemic steroids above specified doses
- Peripheral edema, pericardial, pleural effusion, or ascites requiring medical intervention or limiting daily activities
- Recent cardiovascular events or significant cardiac symptoms within 6 months; QTcF >450 ms on screening ECG
- Active infections requiring systemic treatment within 2 weeks prior to treatment
- Use or expected use of strong CYP3A4 inhibitors or inducers within 7 days before treatment
- Toxicities from prior treatments not resolved to baseline or Grade 1 or less
- Grade 2 or higher peripheral neuropathy at baseline
- Recent major surgery, radiotherapy, antibody therapy, immunotherapy, chemotherapy, or use of anti-tumor Chinese herbal medicines within specified timeframes
- Positive HIV test or history of immunodeficiency
- Active hepatitis B or C infection as defined
- Receipt of live vaccine within 28 days before treatment
- History of hypersensitivity or atopic reactions to investigational product components or monoclonal antibodies
- Pregnant or breastfeeding women
- Other conditions or situations interfering with study participation or safety including mental illness, addiction, or other significant illnesses
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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