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

NCT07892625 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20093-110
• Study Type: interventional
• Target: 338
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to day 21 or 28 from the first dose

Secondary Outcomes (5)

• Objective response rate (ORR) determined by investigators

  up to approximately 24 months

• Disease control rate (DCR) determined by investigators

  up to approximately 24 months

• Duration of response (DoR) determined by investigators

  up to approximately 24 months

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

  up to approximately 24 months

• Overall survival (OS)

  Up to approximately 24 months.

Study Arms (4)

Cohort 1a

EXPERIMENTAL

HS-20093 in combination with ZG006

Drug: HS-20093 for Injection; Drug: ZG006

Cohort 1b

EXPERIMENTAL

HS-20093 in combination with ZG006

Drug: HS-20093 for Injection; Drug: ZG006

Cohort 2a

EXPERIMENTAL

HS-20093 in combination with ZG006 and adebrelimab

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

Cohort 2b

EXPERIMENTAL

HS-20093 in combination with ZG006 and adebrelimab

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

Interventions

HS-20093 for Injection DRUG

The patient will be treated with HS-20093.

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

Cohort 1a; Cohort 1b; Cohort 2a; Cohort 2b

ZG006 DRUG

The patient will be treated with ZG006.

Cohort 1a; Cohort 1b; Cohort 2a; Cohort 2b

Adebrelimab Injection DRUG

The patient will be treated with adebrelimab.

Cohort 2a; Cohort 2b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Injections

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 15, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-10