About this trial
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 small cell lung cancer or neuroendocrine carcinoma; patients with advanced small cell lung cancer must have experienced intolerance, recurrence, or disease progression following prior treatment with a platinum-based therapy combined with immune checkpoint inhibitors, while patients with neuroendocrine carcinoma must have experienced intolerance, recurrence, or disease progression following prior platinum-based therapy; allowed histological subtypes include combined small cell lung cancer and mixed neuroendocrine-non-neuroendocrine neoplasms.
At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to the first administration;
Disqualifiers
History of other malignant tumors within 2 years prior to the first administration, except cured cervical carcinoma in situ or cutaneous basal cell carcinoma;
Presence of Grade ≥ 2 immune-related pneumonitis or immune-related myocarditis, or severe, life-threatening immune-mediated AEs or infusion-related reactions, including those leading to permanent discontinuation, when receiving previous anti-tumor immunotherapy;
History or presence of clinically significant pulmonary impairment due to concurrent lung disease, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sicca syndrome, and sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within the past 6 months;
With central nervous system diseases within 12 months prior to enrollment, such as seizures, cerebral hemorrhage, paralysis, aphasia, cerebral infarction (except for old cerebral infarction), severe brain injury, dementia, Parkinson's disease, cerebellar disease, mental illness, or any autoimmune disease involving the central nervous system;
Trial design
Parallel
Treatments tested in this trial
HLX3901
Drug• HLX3901 will be administered as an intravenous (IV) infusion.
Treatment groups
Trial outcomes
Primary outcomes
The Dose-Limiting Toxicity (DLT) of HLX3901 within 28 days after the first Administration
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 28 days after the first administration of HLX3901.
The maximum tolerated dose (MTD) of HLX3901
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX3901
RP2D
The recommended phase 2 dose of HLX3901
Objective response rate (ORR)
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
Secondary outcomes
Number of participants with adverse events (AEs)
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 6.0
Number of participants with serious adverse events (SAEs)
Duration of response (DOR)
DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause
Progression-free survival (PFS)
The PFS is defined as the time from the date of enrollment to the date of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause,whichever occurred first.
Sponsors and contacts
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