This is an open-label, multicenter Phase I study designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of JH021 injection in patients with advanced solid tumors. JH021 is a bispecific monoclonal antibody targeting EGFR and cMET. The study will assess JH021 in patients with advanced solid tumors for whom standard therapy is unavailable, intolerable, or no longer effective, and will provide data to support further clinical development.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
JH021 is an EGFR/cMET bispecific monoclonal antibody administered by intravenous infusion.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Incidence of dose-limiting toxicities (DLTs) of JH021 in Part Ia
To evaluate the safety and tolerability of JH021 and identify dose-limiting toxicities during the dose-escalation phase.
Time frame: At the end of cycle 1(one cycle is 28 days)
Maximum tolerated dose (MTD) and/or recommanded dose for expansion (RP2D) of JHO21 in Part Ia
To determine the maximum tolerated dose (if reached) and identify the recommended dose for further clinical investigation.
Time frame: Through completion of dose escalation, approximately up to 12 months
Objective response rate (ORR) in Part Ib
To evaluate the preliminary antitumor activity of JH021 monotherapy in patients with EGFR-mutant, locally advanced or metastatic NSCLC who are resistant to third-generation EGFR-TKIs and have progressed after platinum-containing chemotherapy, or have no standard treatment available, as assessed by investigators according to RECIST v1.1.
Time frame: From first dose until disease progression, assessed up to approximately 12 months
Maximum observed plasma concentration (Cmax)
To characterize the maximum observed plasma concentration of JH021
Time frame: From first dose through the PK assessment period, approximately up to 12 months
Time to maximum plasma concentration (Tmax) of JH021
To characterize the time to maximum observed plasma concentration of JH021.
Time frame: from the first dose up to approximately 12 months
Area under the plasma concentration-time curve (AUC) of JH021
To characterize the systemic exposure to JH021 based on the area under the plasma concentration-time curve
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Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shanghai Pulmonary Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
...and 1 more locations
Time frame: From first dose up to approximately 12 months
Terminal elimination half-time (t1/2) of JH021
To characterize the terminal elimination half-time of JH021
Time frame: From first dose up to approximately 12 months
Incidence of anti-drug antibodies (ADAs) in Part Ia
To evaluate the immunogenicity of JH021 by assessing the presence of anti-drug antibodies
Time frame: From first dose through the immunogenicity assessment period, approximately up to 12 months
Preliminary antitumor activity in Part Ia
To evaluate the preliminary antitumor activity of JH021 in patients with advanced solid tumors, as assessed by investigators according to RECIST v1.1.
Time frame: From first dose until disease progression, assessed up to approximately 12 months
Incidence of adverse events(AE)
to eveluate the safety of JH021 by assessing the incidence of advers events
Time frame: From the first dose up to approximately 12 months
Incidence of serious adverse events(SAE)
to eveluate the safety of JH021 by assessing the incidence of serious advers events
Time frame: From the first dose up to approximately 12 months
Incidence of anti-drug antibodies (ADAs) in Part Ib
To evaluate the immunogenicity of JH021 in Part Ib by assessing the presence of anti-drug antibodies.
Time frame: From first dose through the immunogenicity assessment period, approximately up to 12 months