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Not yet recruiting NCT07063407

Phase 1 Study of HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer

Phase I Interventional Extensive Stage Small Cell Lung Cancer (ES-SCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS-20093 in combination with Adebrelimab.
Who it may be relevant to
Registry conditions: Extensive Stage Small Cell Lung Cancer (ES-SCLC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer

Overview

This is a Phase I clinical study of HS-20093. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).

Detailed description

This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with ES-SCLC. Patients with ES-SCLC without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy) will receive maintenance therapy of HS-20093 in combination with Adebrelimab. Patients will continue treatment until disease progression or other criteria for termination of treatment are met.

Interventions

  • Drug HS-20093 in combination with Adebrelimab
    HS-20093 in combination with Adebrelimab will be administered intravenously every 3 weeks until disease progression or other criteria for termination of treatment are met.

Primary outcome measures

  • Pogression-free survival (PFS) determined by investigators according to RECIST 1.1 [Time frame: up to approximately 24 months]
Secondary outcome measures (8)
  • Incidence of adverse events (AEs) [Time frame: From the first dose through 90 days post end of treatment]
  • Objective response rate (ORR) assessed by investigator [Time frame: up to approximately 24 months]
  • Disease Control Rate (DCR) [Time frame: up to approximately 24 months.]
  • Duration of response (DOR) [Time frame: up to approximately 24 months.]
  • Overall survival (OS) [Time frame: up to approximately 24 months.]
  • Observed maximum plasma concentration (Cmax) of HS-20093 [Time frame: up to approximately 24 months.]
  • Area Under the Plasma Concentration-Time Curve (AUC) of HS-20093 [Time frame: up to approximately 24 months.]
  • Percentage of participants with antibodies to HS-20093 in serum [Time frame: up to approximately 24 months.]

Eligibility criteria

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Men or women aged more than or equal to (≥) 18 years.
  • Pathologically diagnosed as ES-SCLC.
  • Without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy).
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1.
  • Estimated life expectancy >12 weeks.
  • Adequate bone marrow reserve or serious organ dysfunction
  • Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
  • Females must have evidence of non-childbearing potential.
  • Signed and dated Informed Consent Form.

Exclusion criteria

  • Uncontrolled pleural effusion or ascites or pericardial effusion.
  • Known and untreated, or active central nervous system metastases.
  • Active autoimmune diseases or active infectious disease
  • Known to have interstitial pneumonia or immune pneumonia
  • History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20093
  • The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
  • The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
  • Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
  • History of neuropathy or mental disorders, including epilepsy and dementia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07063407 · HS-20093-108

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗