This is a Phase Ia/IIb, open-label, first-in-human, multicenter, single-arm, dose escalation study of intratumoral CAN1012 combined with PD-1 in patients with Unresectable or Metastatic Advanced Solid Tumors who have exhausted options for standard of care therapy.
The scope of the study is to evaluate the safety of the combination therapy of CAN1012 and PD-1 in human, study its efficacy and pharmacokinetics profiles, as well as explore its pharmacodynamic effects and biomarkers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the approved dose of 240mg IV Q3W
Sun Yat-Sen University Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
RECRUITINGSafety and tolerability
Safety and tolerability as determined by assessing dose limiting toxicities, the maximum tolerated dose or maximal assessed dose per protocol in combination with toripalimab (anti-PD-1) with patients.
Time frame: 1 year
To determine the MTD and or RP2D of CAN1012 Combined with PD-1
Monitor a tumor response to the combination therapy according to RECIST 1.1 or iRECIST 1.1 as appropriate.
Time frame: Monitor a tumor response to the combination therapy according to RECIST 1.1 or iRECIST 1.1 as appropriate.
To determine the Pharmacokinetics of CAN1012 Combined with PD-1
Determine CAN1012 concentrations in plasma after IT administration.
Time frame: 1 year
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