A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors

NCT07518043
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
174
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Lead sponsor
Shanghai Henlius Biotech
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Start date
2026-07-15
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Number of sites
7
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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).
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Short title
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-06-13
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First posted
2026-04-08
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Registry last updated
2026-07-27
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Primary completion date
2027-08-12
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Start date
2026-07-15
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Participants
174
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Participant count basis
Estimated
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Planned participants
174
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Protocol amendments
0
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Number of sites
7
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Registry sponsor category
Industry
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Lead sponsor
Shanghai Henlius Biotech
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07518043
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ClinicalTrials.gov ID
NCT07518043
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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)

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No

  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).

  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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (1)