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

RECRUITINGPHASE1/PHASE2

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

A Phase Ib/ II Clinical Study to Evaluate the Safety ,Torlerbility , and Efficacy of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Anti-PD-1 Humanized Monocl ) in Patients With Advanced/Metastatic Solid Tumors

NCT06848699•Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

The 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

Detailed Description

This study is an open-label phase Ib/II clinical study 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. The study is divided into two phases: phase Ib dose escalation and phase II dose expansion.The subjects will receive different dosages of HLX43 combined with a fixed dosage (300 mg) of serplulimab, administered via intravenous infusion every 3 weeks (Q3W) .

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the Informed Consent Form (ICF); be willing and able to comply with and complete all trial procedures;
•2. Age at the time of signing the ICF is ≥ 18 years and ≤ 75 years;
•3. Phase Ib enrollment of patients with histologically or cytologically confirmed advanced /metastatic solid tumor who have experienced treatment failure or for whom no standard treatment is available;Phase II enrollment includes advanced /metastatic NSCLC subjects confirmed by histology or cytology, requiring the presence of EGFR mutation and failure or intolerance to EGFR-TKI or/and platinum-based chemotherapy.
•4. Within 4 weeks prior to the first dose, at least one measurable lesion assessed by the investigator according to RECIST 1.1;
•5. Subjects must provide qualified tumor tissue samples for the determination of PD-L1 expression levels.
•6. The ECOG PS score within 7 days prior to the first use of the Investigational Product is 0 or 1;
•7. Expected survival ≥ 12 weeks;
•8. 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):
•9. Female subjects of childbearing potential must meet the following criteria:
•a)The blood pregnancy test must be negative within 7 days prior to the first administration of the medication; b)Agree to use at least one highly effective method of contraception during the trial period and for at least 6 months after the last administration of the drug;c)Breastfeeding is contraindicated.
+1 more criteria

Exclusion Criteria

•1. History of any second malignancy within 3 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
•2. Previously experienced ≥ Grade 3 immune-related Adverse Events during immunotherapy.
•3. Pleural effusion or pericardial effusion, or ascites requiring clinical intervention as determined by the investigator;
•4. Subjects with clinical symptoms of brain metastases, spinal cord compression, meningitis carcinomatosa, or other evidence indicating that brain or spinal cord metastatic lesions are not yet controlled; Note: Subjects with asymptomatic or stable brain metastases, spinal cord compression, or meningitis carcinomatosa as determined by theinvestigator may be eligible for enrollment;
•5. Subjects with a history or current condition of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of pulmonary function, as determined by the sub investigator, that may interfere with the detection and management of suspected drug-related pulmonary toxicity;
•6. The subject has poorly controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure or left ventricular ejection fraction (LVEF) \<50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the past 6 months (excluding lacunar infarction, minor cerebral ischaemia, or transient ischaemic attack); (4) uncontrolled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females, with QTc interval calculated using the Fridericia formula); (5) poorly controlled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg despite active treatment);
•7. History of immunodeficiency diseases, including testing positive for human immunodeficiency virus (HIV), or having other acquired or congenital immunodeficiency diseases, or a history of organ transplant;
•8. Has active pulmonary tuberculosis;
•9. Subjests with active HBV, HCV infection or co-infection;
•10. There is a known active or suspected autoimmune disease. Enrollment is allowed for subjects in a stable condition who do not require systemic immunosuppressive therapy.
+8 more criteria

Locations (3)

Hunan Provincial Cancer Hospital

Hunan, Changsha, China

Shandong Cancer Hospital

Jinan, Shangdong, China

Second Affiliated Hospital of Army Medical University, PLA

Chongqing, China

Key Dates

Start Date

February 25, 2025

Primary Completion Date

October 30, 2026

Completion Date

October 1, 2027

Last Updated

November 17, 2025

Enrollment

105

ESTIMATED participants

Conditions

Solid Tumor CancerNon Small Cell Lung Cancer

Interventions

HLX43 dose 1

DRUG

HLX43 dose 2

DRUG

HLX43 dose 3

DRUG

HLX43 dose 4

DRUG

HLX43 dose 5

DRUG

Serplulimab

DRUG

Contacts

Bo Zhu, Dr

CONTACT

86-023-68755626 bo.zhu@tmmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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