JH021 in Patients With Advanced Solid Tumors or EGFR-Mutant NSCLC

NCT07582822 | Not Yet Recruiting Phase 1

• 1 other identifier: BPL-JH021-ST-1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From first dose until disease progression, assessed up to approximately 12 months

Secondary Outcomes (9)

• Maximum observed plasma concentration (Cmax)

  From first dose through the PK assessment period, approximately up to 12 months

• Time to maximum plasma concentration (Tmax) of JH021

  from the first dose up to approximately 12 months

• Area under the plasma concentration-time curve (AUC) of JH021

  From first dose up to approximately 12 months

• Terminal elimination half-time (t1/2) of JH021

  From first dose up to approximately 12 months

• Incidence of anti-drug antibodies (ADAs) in Part Ia

  From first dose through the immunogenicity assessment period, approximately up to 12 months

Other Outcomes (2)

• Association between EGFR mutation subtype and antitumor activity of JH021

  Baseline biomarker assessment and tumor assessments through approximately 12 months

• Association between MET amplification or expression and antitumor activity of JH021

  Baseline biomarker assessment and tumor assessments through approximately 12 months

Study Arms (1)

JH021

EXPERIMENTAL

Participants will receive JH021 injection in this single-arm, open-label, multiceter phase I study, which consists of a dose escalation part( Part Ia) and a dose-expansion part (Part Ib), to evaluate safety, tolerability, pharmacokinetics , and preliminary antitumor activity in patients with advanced solide tumors.

Biological: JH021

Interventions

JH021 BIOLOGICAL

JH021 is an EGFR/cMET bispecific monoclonal antibody administered by intravenous infusion.

JH021

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Part Ia: patients with advanced solid tumors. Part Ib: patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations (EGFR exon 19 deletion or exon 21 L858R) detected in tumor tissue or plasma ctDNA, who are resistant to third-generation EGFR-TKIs and have progressed after platinum-containing chemotherapy, or have no standard treatment available.
• At least one measurable lesion according to RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Estimated life expectancy of at least 12 weeks.
• Adequate organ function, defined as follows:
• Bone marrow function:
• Absolute neutrophil count \>= 1.5 × 10\^9/L Platelet count \>= 100 × 10\^9/L Hemoglobin \>= 90 g/L, without transfusion, erythropoietin, granulocyte colony-stimulating factor, hepatoprotective therapy, or other medical supportive treatment within 2 weeks before dosing
• Hepatic function:
• Total bilirubin \<= 1.5 × upper limit of normal (ULN) ALT and AST \<= 3 × ULN
• For participants with liver metastases:
• Total bilirubin \<= 2.5 × ULN ALT and AST \<= 5 × ULN
• Renal function:
• Serum creatinine \<= 1.5 × ULN or creatinine clearance \>= 60 mL/min (calculated by Cockcroft-Gault formula)

You may not qualify if:

• Known symptomatic or untreated central nervous system metastases, including leptomeningeal metastases. The following are allowed:
• lesions stable for at least 4 weeks after radiotherapy before first dose, as confirmed by MRI/CT; no uncontrolled neurological symptoms or signs, such as seizures, headache, central nausea/vomiting, progressive neurological dysfunction, or papilledema; asymptomatic untreated brain metastases not requiring local treatment (such as radiotherapy) or systemic treatment (such as mannitol or corticosteroids).
• 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.
• Continuous systemic treatment with corticosteroids at a dose \>10 mg/day prednisone equivalent or other immunosuppressive therapy within 14 days before first dose or during the study. Exceptions:
• inhaled or topical corticosteroids at \<=10 mg/day prednisone equivalent in the absence of active autoimmune disease; short-term corticosteroids \>10 mg/day prednisone equivalent for prophylaxis (e.g., contrast allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reaction after allergen exposure).
• 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.
• Known interstitial lung disease.
• Known HIV antibody positivity; active hepatitis B virus infection (participants with positive HBsAg require HBV-DNA testing and are excluded if HBV-DNA is positive); active hepatitis C virus infection (positive HCV antibody and positive HCV-RNA); or positive syphilis antibody test.
• Severe concomitant diseases, including active gastrointestinal bleeding, intestinal obstruction, paralytic ileus, glaucoma, uncontrolled diabetes mellitus, or other serious medical conditions.
• Deep vein thrombosis.
• Pleural effusion, pericardial effusion, or ascites that cannot be controlled with appropriate intervention within 4 weeks before first dose. Small effusions detectable only by imaging are allowed.
• Major cardiovascular disease within 6 months before first dose, including severe arrhythmia, acute myocardial ischemia, unstable angina, congestive heart failure (New York Heart Association class \>=2), left ventricular ejection fraction \<50%, history of long QT syndrome or confirmed family history of long QT syndrome, or QTcF \>450 msec in males or \>470 msec in females.
• Hypertension not controlled by standard treatment (systolic blood pressure \>=140 mmHg and/or diastolic blood pressure \>=90 mmHg).

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (11)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Shanghai Pulmonary Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Yibin Second People's Hospital

Yibin, Sichuan, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Shanghai East Hospital

Shanghai, China

Location

Study Officials

• Caicun Zhou, Doctor

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanmin Wang, master

CONTACT

13911386413; wangyanmin@biotechplc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group assignment. All enrolled participants will receive JH021 injection in an open-label, multicenter phase I study with dose-escalation and dose expansion parts.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)