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OncoMatch/Clinical Trials/NCT06848699

A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors

Is NCT06848699 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for solid tumor cancer.

Phase 1/2RecruitingShanghai Henlius BiotechNCT06848699Data as of May 2026

Treatment: HLX43 dose 1 · HLX43 dose 2 · HLX43 dose 3 · HLX43 dose 4 · HLX43 dose 5 · SerplulimabThe study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced/metastatic solid tumors

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Small Cell Lung Cancer

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Required: EGFR mutation

Disease stage

Required: Stage IV

Metastatic disease required

advanced /metastatic solid tumor...at least one measurable lesion assessed by the investigator according to RECIST 1.1

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: egfr tyrosine kinase inhibitor

Must have received: platinum-based chemotherapy

Lab requirements

Blood counts

Major organ functions are normal, meeting the following criteria (within 14 days prior to the first administration in this study, no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatment was received)

Kidney function

Major organ functions are normal, meeting the following criteria (within 14 days prior to the first administration in this study, no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatment was received)

Liver function

Major organ functions are normal, meeting the following criteria (within 14 days prior to the first administration in this study, no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatment was received)

Cardiac function

No NYHA class II or higher heart failure or LVEF <50%; no unstable angina; no myocardial infarction or cerebrovascular accident within the past 6 months (excluding lacunar infarction, minor cerebral ischaemia, or transient ischaemic attack); no uncontrolled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females, with QTc interval calculated using the Fridericia formula); no poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg despite active treatment)

Major organ functions are normal, meeting the following criteria (within 14 days prior to the first administration in this study, no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatment was received)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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