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Extensive Stage Small Cell Lung Cancer (ES-SCLC)Phase 1NCT07063407

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

A Phase 1 study testing HS-20093 in combination with Adebrelimab in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Shanghai Hansoh Biomedical Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HS-20093 in combination with Adebrelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
31 Jul 2025to 31 May 2027
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

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).

Read the 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.

Being tested
HS-20093 in combination with Adebrelimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20093 in combination with AdebrelimabDrug

    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.

Study groups in NCT07063407
Study groupRoleWhat they receive
HS-20093 and AdebrelimabExperimentalNot described
Receives: Drug: HS-20093 in combination with Adebrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pogression-free survival (PFS) determined by investigators according to RECIST 1.1

    PFS is defined as the time from date of first dose until the documentation of objective PD or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.

    Measured: up to approximately 24 months

Secondary outcomes (8)

  1. Incidence of adverse events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered an investigational product, which may present with symptoms, signs, disease, or laboratory abnormalities, but do not necessarily have a causality with the investigational product.

    Measured: From the first dose through 90 days post end of treatment

  2. Objective response rate (ORR) assessed by investigator

    ORR is defined as the percentage of patients with a CR or PR that is confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1

    Measured: up to approximately 24 months

  3. Disease Control Rate (DCR)

    Disease control is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks).

    Measured: up to approximately 24 months.

  4. Duration of response (DOR)

    Duration of response assessed by RECIST 1.1. Duration of response is defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression (PD) or death.

    Measured: up to approximately 24 months.

  5. Overall survival (OS)

    OS is defined as time from first study treatment to death due to any cause.

    Measured: up to approximately 24 months.

  6. Observed maximum plasma concentration (Cmax) of HS-20093

    Cmax of HS-20093

    Measured: up to approximately 24 months.

  7. Area Under the Plasma Concentration-Time Curve (AUC) of HS-20093

    AUC of HS-20093

    Measured: up to approximately 24 months.

  8. Percentage of participants with antibodies to HS-20093 in serum

    Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points

    Measured: up to approximately 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start31 Jul 2025 (estimated)
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07063407
Sponsor's protocol ID
HS-20093-108
Status last verified
Jul 2025
First submitted
3 Jul 2025
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

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