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
Qualifiers
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
Treatments tested in this trial
- JH021
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov