A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.
The scope of the study is to evaluate the safety of CAN2109 in humans, explore its safety, efficacy and collect data on the pharmacokinetics, as well as on the pharmacodynamic effect of the drug on the immune system locally and systemically, and on tumor markers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
CAN2109 IT injection (once every 3 weeks)
Sun Yat-Sen University Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
RECRUITINGSafety
determined by assessment of dose limiting toxicities per protocol of CAN2109 with cancers.
Time frame: 12 months
Recommended Phase 2 Dose (RP2D)
To determine a recommended phase 2 dose of CAN21909 for further development by evaluating number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time frame: 12 months
tolerability
determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN2109 with cancers.
Time frame: 12 months
To determine the efficacy of CAN2109
Proportion of patients experiencing a tumor response or a stable disease according to RECIST 1.1 or iRECIST 1.1 as appropriate.
Time frame: 12 months
To evaluate the pharmacodynamics of CAN2109
Maximum observed plasma and tumor concentration of CAN2109 after IT administration.
Time frame: 12 months
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