> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-hlx18-vs-opdivo-in-multiple-resected-solid-tumors-46dffa1e-b0d4-4edb-bbdf-6fe1fbdbcd26 > Record changed: 2026-10-13 # A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors NCT07518043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) Participants 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) Lead sponsor Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) Start date 2026-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) Number of sites 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Short title** A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Official title** A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® (US-sourced OPDIVO®) in Multiple Resected Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Dates **Completion date** 2028-06-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **First posted** 2026-04-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Registry last updated** 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Primary completion date** 2027-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Start date** 2026-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Size and sites **Participants** 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Planned participants** 174 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Number of sites** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Lead sponsor** Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Identifiers **Registry ID** NCT07518043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **ClinicalTrials.gov ID** NCT07518043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Outcomes ### Primary outcomes 1. AUC0-28d Timeframe: From time 0 to 28 days after the 1st dose(4 weeks) 2. AUCss Timeframe: From time 0 to 28 days after the 4th dose(16 weeks) ### Secondary outcomes 1. maximum serum drug concentration (Cmax) Timeframe: up to 16 weeks 2. trough serum drug concentration (Ctrough) Timeframe: up to 16 weeks 3. maximum serum drug concentration at steady state (Cmax,ss) Timeframe: up to 16 weeks 4. trough serum drug concentration at steady state (Ctrough,ss) Timeframe: up to 16 weeks 5. Disease-free survival (DFS) Timeframe: up to 12 months 6. Adverse events (AEs); Serious adverse events (SAEs); Adverse events of special interest (AESIs) (including immune-related adverse events and infusion-related reactions) Timeframe: From enrollment to the end of 90-day safety follow-up (up to 15 months) 7. Number of participants with abnormal vital signs, abnormal physical examination findings, abnormal Laboratory tests results (hematology, serum chemistry, thyroid function, coagulation function, and myocardial markers) or abnormal 12-lead ECG readings. Timeframe: From enrollment to the end of 30-day safety follow-up (up to 13 months) 8. Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) Timeframe: up to 24 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** No ### Inclusion criteria 1. Participants must have signed and dated an IRB/IEC approved written informed consent form. 2. Aged 18 to 70 years at the time of signing the ICF. 3. 18 kg/m² ≤ BMI ≤ 30 kg/m² and 50 kg ≤ body weight ≤ 85 kg. 4. Histologically confirmed solid tumors (EC/GEJC, Melanoma, or UC) status post R0 resection. 5. For EC/GEJC: residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection. 6. For Melanoma: Stage IIB-IV after complete surgical resection with documented negative margins. 7. For UC: High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0). 8. Documented disease-free status (no recurrence) by imaging and physical exam within 4 weeks prior to randomization. 9. Adequate recovery from prior surgery or systemic therapy. 10. ECOG Performance Status of 0. 11. Adequate organ function. 12. Agreement to use effective contraception (negative pregnancy test for WOCBP). ### Exclusion criteria 1. History of illicit drug use or alcohol abuse within 12 months prior to randomization. 2. Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC/GEJC, or ocular melanoma. 3. UC-specific surgical exclusions: status post partial cystectomy or partial nephrectomy. 4. EC/GEJC treatment violations: failure to receive mandatory preoperative concurrent CRT (mono-therapy is ineligible). 5. Prior treatment with nivolumab or any other immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4). 6. Other primary active malignancies within 5 years or history of organ/bone marrow transplantation. 7. Significant cardiovascular disease (MI, cerebrovascular disease) or unstable arrhythmia (QTc > 450ms/470ms) within 6 months. 8. Chronic heart failure (NYHA Class III-IV) or LVEF < 50% at screening. 9. Presence of interstitial pneumonia, pneumonitis, or severe lung function abnormalities. 10. Active autoimmune disease requiring systemic immunosuppressive therapy. 11. Known HIV infection, active Hepatitis B/C, or active pulmonary tuberculosis. 12. Peripheral neuropathy ≥ Grade 2 or history of carcinomatosis meningitis. 13. Use of systemic corticosteroids (>10 mg/day prednisone equivalent), immunosuppressants, or live vaccines within 28 days. 14. Recent or planned participation in other investigational drug, device, or surgical studies. 15. Severe allergic reactions to monoclonal antibodies or any condition deemed unsuitable by the investigator. 16. The investigator has a clear reason to believe that participation in this study would be detrimental to the participant. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Sites - Fujian Medical University Union HospitalFuzhou, ChinaRecruiting - The First Affiliated Hospital Zhejiang University School Of MedicineHangzhou, ChinaRecruiting - The First Affiliated Hospital of Henan University of Science & TechnologyLuoyang, ChinaRecruiting - The Second Hospital of Tianjin Medical UniversityTianjin, ChinaRecruiting - The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaRecruiting - Union Hospital, Tongji Medical College,Huazhong University of Science and TechnologyWuhan, ChinaRecruiting - The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07518043) ## Related records ### Drugs (1) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) ### Lead sponsors (1) - [Shanghai Henlius Biotech](https://trialight.com/data/company/shanghai-henlius-biotech-aec8d786-7c6e-4c63-86f6-2a3a648aa0f1.md) ### Conditions (3) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) - [Transitional cell carcinoma](https://trialight.com/data/condition/transitional-cell-carcinoma-19611feb-3997-59b1-ad3d-49b845cbe40f.md) - [Urothelial carcinoma](https://trialight.com/data/condition/urothelial-carcinoma-b2aa266d-2d5f-5e5d-a0de-62274f2dc094.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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