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Extensive Stage Small Cell Lung Cancer (ES-SCLC)Phase 1NCT07892625

A Phase I Study of HS-20093 in Combination With ZG006 With or Without Adebrelimab in Patients With ES-SCLC

A Phase 1 study testing HS-20093 for Injection, ZG006 and Adebrelimab Injection in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Hansoh BioMedical R&D Company.

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 multicenter, open-label Phase I study evaluating the safety, tolerability, pharmacokinetic, and efficacy of Intravenous HS-20093 in combination with ZG006 with or without adebrelimab in patients with extensive-stage small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HS-20093 for Injection, ZG006 and Adebrelimab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
No sites listed yet
Study dates
15 Nov 2026to 15 Sep 2029
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

  • Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent.
  • Men or women aged more than or equal to (≥) 18 years.
  • At least one extra-cranial measurable lesion according to RECIST 1.1.
  • Histologically or cytologically diagnosed as ES-SCLC.
  • Adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
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  • Life expectancy >= 12 weeks.
  • Men or women should be using adequate contraceptive measures throughout the study.
  • Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.

Who cannot join

  • Uncontrolled pleural effusion or peritoneal effusion.
  • Adverse reactions caused by previous treatments.
  • History of other primary solid tumors.
  • Severe, uncontrolled or active cardiovascular or cerebrovascular diseases.
  • Severe or uncontrolled diabetes or hypertension.
  • Clinically significant hemorrhage symptoms or significant hemorrhagic tendency.
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  • History of severe arterial-venous thrombosis within 3 months prior to the first administration.
  • History of severe infection within 4 weeks prior to the first administration.
  • Active autoimmune diseases or active infectious diseases.
  • History of severe neurological or mental disorders.
  • Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child-Pugh class B cirrhosis.
  • Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Any condition that probably endangers the safety of the participants or interferes with the study assessment.

About this study

Official title: A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20093 in Combination With ZG006 With or Without Adebrelimab in Patients With Extensive Stage Small Cell Lung Cancer

This is a multicenter, open-label Phase I study evaluating the safety, tolerability, pharmacokinetic, and efficacy of Intravenous HS-20093 in combination with ZG006 with or without adebrelimab in patients with extensive-stage small cell lung cancer.

Read the detailed description

This is a multicenter, open-label Phase I study evaluating the safety, tolerability, pharmacokinetic, and efficacy of Intravenous HS-20093 in combination with ZG006 with or without adebrelimab in patients with extensive-stage small cell lung cancer.

The study involves two cohorts, Cohort 1: HS-20093 in combination with ZG006; Cohort 2: HS-20093 in combination with ZG006 and adebrelimab. Each cohort contains two dosing regimens: every two weeks (Q2W) and every three weeks (Q3W). Two phases are included in each cohort: dose exploration phase and dose expansion phase.

Being tested
HS-20093 for Injection, ZG006, Adebrelimab Injection
Keywords
Small Cell Lung Cancer, HS-20093, B7H3, Antibody-Drug Conjugates, ZG006, DLL3, PD-L1 inhibitor
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • HS-20093 for InjectionDrug

    Also called Risvutatug Rezetecan, Ris-Rez, GSK5764227

    The patient will be treated with HS-20093.

  • ZG006Drug

    The patient will be treated with ZG006.

  • Adebrelimab InjectionDrug

    The patient will be treated with adebrelimab.

Study groups in NCT07892625
Study groupRoleWhat they receive
Cohort 1aExperimentalHS-20093 in combination with ZG006
Receives: Drug: HS-20093 for Injection; Drug: ZG006
Cohort 1bExperimentalHS-20093 in combination with ZG006
Receives: Drug: HS-20093 for Injection; Drug: ZG006
Cohort 2aExperimentalHS-20093 in combination with ZG006 and adebrelimab
Receives: Drug: HS-20093 for Injection; Drug: ZG006; Drug: Adebrelimab Injection
Cohort 2bExperimentalHS-20093 in combination with ZG006 and adebrelimab
Receives: Drug: HS-20093 for Injection; Drug: ZG006; Drug: Adebrelimab Injection

What is being measured

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

  1. The maximum tolerated dose (MTD) or maximum applicable dose (MAD) for combination treatments

    To determine the MTD or MAD for further evaluation of HS-20093 with other anti-cancer agents in subjects with Extensive Stage Small Cell Lung Cancer

    Measured: Up to day 21 or 28 from the first dose

  2. The incidence rate of dose-limiting toxicities (DLT) events in combination treatments

    To determine the incidence rate of DLT events for further evaluation of HS-20093 with other anti-cancer agents in subjects with Extensive Stage Small Cell Lung Cancer

    Measured: Up to day 21 or 28 from the first dose

Secondary outcomes (5)

  1. Objective response rate (ORR) determined by investigators

    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

  2. Disease control rate (DCR) determined by investigators

    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

  3. Duration of response (DoR) determined by investigators

    The duration of remission (DoR) is defined as the time period between the date of the first occurrence of remission and the date of the first disease progression or any cause of death.

    Measured: up to approximately 24 months

  4. Progression-free survival (PFS) determined by investigators according to RECIST 1.1

    PFS is defined as the time from first dose until PD or death from any cause (whichever occurred first).

    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.

Timeline

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

  1. First posted23 Oct 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion15 Sep 2028 (estimated)
  4. Study completion15 Sep 2029 (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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
338 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07892625
Sponsor's protocol ID
HS-20093-110
Status last verified
Oct 2026
First submitted
13 Aug 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20093 for Injection, ZG006 and Adebrelimab Injection in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Hansoh BioMedical R&D Company.

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 9 inclusion and 13 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 23 Oct 2026. 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?

The maximum tolerated dose (MTD) or maximum applicable dose (MAD) for combination treatments (time frame: Up to day 21 or 28 from the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07892625.

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 23 Oct 2026.

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