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.
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
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer (ES-SCLC)
- 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
- Are there results?
- Not yet: the study is under way
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 group | Role | What they receive |
|---|---|---|
| HS-20093 and Adebrelimab | Experimental | Not 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.
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)
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
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
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.
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.
Overall survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Measured: up to approximately 24 months.
Observed maximum plasma concentration (Cmax) of HS-20093
Cmax of HS-20093
Measured: up to approximately 24 months.
Area Under the Plasma Concentration-Time Curve (AUC) of HS-20093
AUC of HS-20093
Measured: up to approximately 24 months.
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.
- First posted14 Jul 2025
- Study start31 Jul 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung Cancer (ES-SCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Hansoh Biomedical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07063407
- Acronym / sponsor ID
- HS-20093-108
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Hansoh Biomedical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-20093 and Adebrelimab | Experimental | Drug: HS-20093 in combination with Adebrelimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20093 in combination with AdebrelimabHS-20093 in combination with Adebrelimab will be administered intravenously every 3 weeks until disease progression or other criteria for termination of treatment are met. | Drug | HS-20093 and Adebrelimab |
Primary outcome
Pogression-free survival (PFS) determined by investigators according to RECIST 1.1
Time frame: up to approximately 24 months
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.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pogression-free survival (PFS) determined by investigators according to RECIST 1.1 (time frame: up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.