JH021 in Patients With Advanced Solid Tumors or EGFR-Mutant NSCLC
ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBiotech Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 18 to 75 years, inclusive.
Histologically or cytologically confirmed malignancy with disease progression since the most recent antitumor therapy, and for whom standard treatment is unavailable, not tolerated, or refused.
At least one measurable lesion according to RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
History of another malignancy within 5 years before first dose, except for malignancies treated curatively with no recurrence, including non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or lobular carcinoma in situ of the breast, and localized prostate cancer.
Receipt of chemotherapy, targeted therapy, or other systemic antitumor therapy within 4 weeks or 5 half-lives before first dose, whichever is shorter; or receipt of Chinese herbal medicine or Chinese patent medicine for antitumor treatment within 2 weeks before first dose.
Major surgery or radical radiotherapy within 4 weeks before first dose; palliative radiotherapy within 2 weeks before first dose; or therapeutic radiopharmaceuticals (e.g., strontium, samarium) within 8 weeks before first dose.
Active infection requiring systemic treatment within 2 weeks before first dose, including active tuberculosis or pneumonia of any grade.
Trial design
Design model
Single group
Treatments tested in this trial
JH021
Biological/VaccineJH021 is an EGFR/cMET bispecific monoclonal antibody administered by intravenous infusion.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: JH021Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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 months3
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 monthsSecondary outcomes
1
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 months2
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 months3
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
Time frame
From first dose up to approximately 12 months4
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 monthsOther outcomes
1
Association between EGFR mutation subtype and antitumor activity of JH021
To explore the relationship between EGFR mutation subtype and antitumor activity of JH021.
Time frame
Baseline biomarker assessment and tumor assessments through approximately 12 months2
Association between MET amplification or expression and antitumor activity of JH021
To explore the relationship between MET amplification or MET expression and antitumor activity of JH021
Time frame
Baseline biomarker assessment and tumor assessments through approximately 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: