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

ConditionsSolid Tumor CancerNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 or/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;

Disqualifiers

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.

Previously experienced ≥ Grade 3 immune-related Adverse Events during immunotherapy.

Pleural effusion or pericardial effusion, or ascites requiring clinical intervention as determined by the investigator;

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • HLX43 dose 1

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 dose 2

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 dose 3

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 dose 4

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 dose 5

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • Serplulimab

    Drug

    anti-PD-1 humanized monoclonal antibody injection

Treatment groups

105 Participants
are divided into 5 treatment groups
Group A: HLX43 dose 1Experimental treatment 2 interventions
Group B: HLX43 dose 2Experimental treatment 2 interventions
Group C: HLX43 dose 3Experimental treatment 2 interventions
Group D: HLX43 dose 4Experimental treatment 2 interventions
Group E: HLX43 dose 5Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

DLT

The proportion of subjects experiencing dose-limiting toxicity (DLT) events in each dosage group during the DLT observation period

Time frame
21 days after the first dose
2

MTD

The maximum tolerated dose of HLX43 incombination with serplulimab

Time frame
through study completion, an average of 12 months
3

ORR

Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)

Time frame
up to 24 weeks

Secondary outcomes

1

Incidence and severity of adverse events (AEs)

severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version \[v\] 5.0

Time frame
from the date of the first dose to to 90 days after the last dose or the initiation of another anticancer treatment (whichever occurs first).
2

RP2/3D

RP2/3D of HLX43 combined with serplulimab in NSCLC patients

Time frame
through study completion, an average of 12 months
3

PFS

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC according to the RECIST v1.1 criteria.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
4

PFS

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV according to the RECIST v1.1 criteria.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov
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