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Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

ConditionGastric or Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech

About this trial

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;

Aged ≥ 18 years AND ≤ 75 years at the time of signing the ICF, male or female;

Histologically or cytologically confirmed advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Locally advanced or metastatic Gastric or Gastroesophageal Junction Adenocarcinoma that has failed or progressed after at least one standard systemic treatment in the past, or has experienced intolerable toxicity (CTCAE≥ grade 3), or has contraindications to standard treatment and is not suitable for radical treatment.

Disqualifiers

Have previously received any drug treatment targeting topoisomerase I, including chemotherapy and ADC.

Radical radiation therapy within 3 months prior to the first dose;

History of any second malignancy within 2 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;

History of adverse events leading to permanent discontinuation of immunotherapy, or occurrence of ≥ Grade 2 immune-related pneumonitis or myocarditis during prior immunotherapy;

Trial design

Design model

Parallel

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. DOSE 1 is 2.0mg/kg

  • 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. DOSE 1 is 2.5mg/kg

  • 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. DOSE 1 is 3.0mg/kg

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: HLX43 DOSE 1Experimental treatment 1 intervention
Group B: HLX43 DOSE 2Experimental treatment 1 intervention
Group C: HLX43 DOSE 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate (ORR) (assessed by the Independent Radiology Review Committee \[IRRC\] as per RECIST v1.1).

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months

Secondary outcomes

1

ORR

Objective response rate (ORR) (assessed by the investigator as per RECIST v1.1).

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
2

PFS

Progression-free survival (PFS) (assessed by the IRRC and the investigator as per RECIST v1.1)

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
3

OS

Overall survival (OS)

Time frame
From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months
4

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 date of the first dose of study drug until the date of death from any cause, assessed up to 24 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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