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Not Yet RecruitingNCT07063407

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

A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Shanghai Hansoh Biomedical Co., Ltd · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Detailed description

This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with ES-SCLC. Patients with ES-SCLC without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy) will receive maintenance therapy of HS-20093 in combination with Adebrelimab. Patients will continue treatment until disease progression or other criteria for termination of treatment are met.

Conditions

Interventions

TypeNameDescription
DRUGHS-20093 in combination with AdebrelimabHS-20093 in combination with Adebrelimab will be administered intravenously every 3 weeks until disease progression or other criteria for termination of treatment are met.

Timeline

Start date
2025-07-31
Primary completion
2026-04-30
Completion
2027-05-31
First posted
2025-07-14
Last updated
2025-07-14

Regulatory

Source: ClinicalTrials.gov record NCT07063407. Inclusion in this directory is not an endorsement.