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Not yet recruitingNCT07892625Updated Oct 23, 2026

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

A Phase 1 interventional study of HS-20093 for Injection and ZG006 in Extensive Stage Small Cell Lung Cancer (ES-SCLC), sponsored by Hansoh BioMedical R&D Company. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Hansoh BioMedical R&D Company (part of Hansoh Pharmaceutical Group Company Limited) · Phase 1, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
338
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Keywords

  • Small Cell Lung Cancer
  • HS-20093
  • B7H3
  • Antibody-Drug Conjugates
  • ZG006
  • DLL3
  • PD-L1 inhibitor
03

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 338 is above the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Hansoh BioMedical R&D Company is the lead sponsor of 47 studies on the registry; 43 are open to participants now.

Browse Hansoh BioMedical R&D Company studies →All Hansoh Pharmaceutical Group Company Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled pleural effusion or peritoneal effusion.
  2. Adverse reactions caused by previous treatments.
  3. History of other primary solid tumors.
  4. Severe, uncontrolled or active cardiovascular or cerebrovascular diseases.
  5. Severe or uncontrolled diabetes or hypertension.
  6. Clinically significant hemorrhage symptoms or significant hemorrhagic tendency.
  7. History of severe arterial-venous thrombosis within 3 months prior to the first administration.
  8. History of severe infection within 4 weeks prior to the first administration.
  9. Active autoimmune diseases or active infectious diseases.
  10. History of severe neurological or mental disorders.
  11. Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child-Pugh class B cirrhosis.
  12. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  13. Any condition that probably endangers the safety of the participants or interferes with the study assessment.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
338 participants (estimated)

Study arms

  • Experimental
    Cohort 1a

    HS-20093 in combination with ZG006

    Drug: HS-20093 for Injection · Drug: ZG006

  • Experimental
    Cohort 1b

    HS-20093 in combination with ZG006

    Drug: HS-20093 for Injection · Drug: ZG006

  • Experimental
    Cohort 2a

    HS-20093 in combination with ZG006 and adebrelimab

    Drug: HS-20093 for Injection · Drug: ZG006 · Drug: Adebrelimab Injection

  • Experimental
    Cohort 2b

    HS-20093 in combination with ZG006 and adebrelimab

    Drug: HS-20093 for Injection · Drug: ZG006 · Drug: Adebrelimab Injection

Interventions

  • DrugHS-20093 for Injection

    The patient will be treated with HS-20093.

    Also known as: Risvutatug Rezetecan, Ris-Rez, GSK5764227

  • DrugZG006

    The patient will be treated with ZG006.

  • DrugAdebrelimab Injection

    The patient will be treated with adebrelimab.

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: Up to day 21 or 28 from the first dose

Secondary outcomes

  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

    Time frame: 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).

    Time frame: 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.

    Time frame: 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).

    Time frame: up to approximately 24 months

  5. Overall survival (OS)

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

    Time frame: Up to approximately 24 months.

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07892625
Lead sponsor
Hansoh BioMedical R&D Company
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Sep 15, 2028 (estimated)
Completion
Sep 15, 2029 (estimated)
Last update
Oct 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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