Phase 1 Study of HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer

NCT07063407 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-20093-108
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Outcome Measures

Primary Outcomes (1)

• 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.

  up to approximately 24 months

Secondary Outcomes (8)

• Incidence of adverse events (AEs)

  From the first dose through 90 days post end of treatment

• Objective response rate (ORR) assessed by investigator

  up to approximately 24 months

• Disease Control Rate (DCR)

  up to approximately 24 months.

• Duration of response (DOR)

  up to approximately 24 months.

• Overall survival (OS)

  up to approximately 24 months.

Study Arms (1)

HS-20093 and Adebrelimab

EXPERIMENTAL

Drug: HS-20093 in combination with Adebrelimab

Interventions

HS-20093 in combination with Adebrelimab DRUG

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.

HS-20093 and Adebrelimab

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Hansoh Biomedical Co., Ltd: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: July 31, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07