A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
About this study
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC).
- Condition
- Esophageal and/or Cardia Cancer, Melanoma, Urothelial Carcinoma (UC)
- Tested
- HLX18, OPDIVO®
- Sponsor
- Shanghai Henlius Biotech
Who can join
- Age
- 18 to 70 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 15
- Minimum age: 18 years
- Maximum age: 70 years
- Study condition: Esophageal and/or Cardia Cancer, Melanoma, Urothelial Carcinoma (UC)
- Participants must have signed and dated an IRB/IEC approved written informed consent form.
- Aged 18 to 70 years at the time of signing the ICF.
- 18 kg/m² ≤ BMI ≤ 30 kg/m² and 50 kg ≤ body weight ≤ 85 kg.
- Histologically confirmed solid tumors (EC/GEJC, Melanoma, or UC) status post R0 resection.
- For EC/GEJC: residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection.
- For Melanoma: Stage IIB-IV after complete surgical resection with documented negative margins.
- For UC: High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0).
- Documented disease-free status (no recurrence) by imaging and physical exam within 4 weeks prior to randomization.
- Adequate recovery from prior surgery or systemic therapy.
- ECOG Performance Status of 0.
- Adequate organ function.
- Agreement to use effective contraception (negative pregnancy test for WOCBP).
Exclusion 16
- History of illicit drug use or alcohol abuse within 12 months prior to randomization.
- Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC/GEJC, or ocular melanoma.
- UC-specific surgical exclusions: status post partial cystectomy or partial nephrectomy.
- EC/GEJC treatment violations: failure to receive mandatory preoperative concurrent CRT (mono-therapy is ineligible).
- Prior treatment with nivolumab or any other immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4).
- Other primary active malignancies within 5 years or history of organ/bone marrow transplantation.
- Significant cardiovascular disease (MI, cerebrovascular disease) or unstable arrhythmia (QTc \> 450ms/470ms) within 6 months.
- Chronic heart failure (NYHA Class III-IV) or LVEF \< 50% at screening.
- Presence of interstitial pneumonia, pneumonitis, or severe lung function abnormalities.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Known HIV infection, active Hepatitis B/C, or active pulmonary tuberculosis.
- Peripheral neuropathy ≥ Grade 2 or history of carcinomatosis meningitis.
- Use of systemic corticosteroids (\>10 mg/day prednisone equivalent), immunosuppressants, or live vaccines within 28 days.
- Recent or planned participation in other investigational drug, device, or surgical studies.
- Severe allergic reactions to monoclonal antibodies or any condition deemed unsuitable by the investigator.
- The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.
Where
7 sites, 7 recruiting
Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
The Second Hospital of Tianjin Medical University
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, China
and 1 more site on ClinicalTrials.gov
Contact
-
Chang Chen
+86 138 1686 9003 chenthoracic@163.com
Potential match only. Final eligibility is determined by the study team.