This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.
This open-label, multicenter, phase 1b/2 trial is conducted to evaluate the safety, tolerability and preliminary activity in patients with advanced solid tumors and lymphomas. This trial includes two parts: the phase 1b dose escalation part and the phase 2 dose expansion part. In the dose escalation part with a standard 3+3 design, IMM01 (1.0, 1.5, 2.0 mg/kg) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. In the dose expansion part, IMM01 (the dose determined in the dose escalation part) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. And the cohorts includes HNSCC, NSCLC, SCLC, R/R cHL and others.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
309
IMM01 (1.0, 1.5, 2.0 mg/kg) QW IV in the dose escalation part. IMM01 (dose determined in the dose escalation part) QW IV in the dose expansion part.
Tislelizumab 200mg Q3W IV
Zhejiang Cancer Hospital
Hangzhou, China
RECRUITINGShandong Provincial Institute of Cancer Prevention and Treatment
Jinan, China
RECRUITINGThe Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, China
Dose-limiting toxicity in dose escalation part
Time frame: DLT observation 21 days
MTD/RP2D in dose escalation part
Time frame: DLT observation 21 days
ORR in dose expansion part
Time frame: up to 12 months
TRAEs
Time frame: up to 12 months
PFS
Time frame: up to 12 months
DOR
Time frame: up to 12 months
DCR
Time frame: up to 12 months
Cmax
Time frame: up to 12 months
T1/2
Time frame: up to 12 months
AUC
Time frame: up to 12 months
ADA
Time frame: up to 12 months
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Shanghai Chest Hospital
Shanghai, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, China
RECRUITING