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
Conditions the study is for: Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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

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

Read the detailed description

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.

Conditions: Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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 group	Role	What they receive
Cohort 1a	Experimental	HS-20093 in combination with ZG006 Receives: Drug: HS-20093 for Injection; Drug: ZG006
Cohort 1b	Experimental	HS-20093 in combination with ZG006 Receives: Drug: HS-20093 for Injection; Drug: ZG006
Cohort 2a	Experimental	HS-20093 in combination with ZG006 and adebrelimab Receives: Drug: HS-20093 for Injection; Drug: ZG006; Drug: Adebrelimab Injection
Cohort 2b	Experimental	HS-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.

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
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)

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
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
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
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
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.

15 Nov 202615 Sep 2029

First posted23 Oct 2026
Study start15 Nov 2026 (estimated)
Primary completion15 Sep 2028 (estimated)
Study completion15 Sep 2029 (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: 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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
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RecruitingPhase 3
DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy
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RecruitingPhase 1/2
A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy
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RecruitingPhase 2
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive Stage Lung Small Cell Cancer

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