Evaluation of SYS6005 in Patients With Advanced Malignant Tumor

Recruiting Phase 1 Interventional Study
B-cell Malignancies Solid Tumors
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants who are voluntarily enrolled in this study and sign the informed consent form (ICF); 2. Age ≥ 18 years old, male or female; 3. Patients with advanced malignant tumors confirmed by cytology or histology, who have failed standard therapy or are intolerant to standa…
Contacts

Clinical Trials Information Group officer

86-0311-69085587

ctr-contact@cspc.cn

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