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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

• Age at the time of signing the ICF is ≥ 18 years and ≤ 75 years;

• 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 and platinum-based chemotherapy.

• Within 4 weeks prior to the first dose, at least one measurable lesion assessed by the investigator according to RECIST 1.1;

• Subjects must provide qualified tumor tissue samples for the determination of PD-L1 expression levels.

• The ECOG PS score within 7 days prior to the first use of the Investigational Product is 0 or 1;

• Expected survival ≥ 12 weeks;

• 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):

• 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.

⁃ Male subjects must meet the following criteria: agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose.

Locations
Other Locations
China
Second Affiliated Hospital of Army Medical University, PLA
RECRUITING
Chongqing
Hunan Provincial Cancer Hospital
RECRUITING
Hunan
Contact Information
Primary
Bo Zhu, Dr
bo.zhu@tmmu.edu.cn
86-023-68755626
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 105
Treatments
Experimental: HLX43 dose 1
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
Experimental: HLX43 dose 2
: Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
Experimental: HLX43 dose 3
: Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
Experimental: HLX43 dose 4
: Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
Experimental: HLX43 dose 5
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
Sponsors
Leads: Shanghai Henlius Biotech

This content was sourced from clinicaltrials.gov

Similar Clinical Trials