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

Phase 1Not Yet RecruitingNCT07063407

Shanghai Hansoh Biomedical Co., Ltd50 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Interventions

HS-20093 in combination with AdebrelimabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Men or women aged more than or equal to (≥) 18 years. 2. Pathologically diagnosed as ES-SCLC. 3. Without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy). 4. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1. 5. Estimated life expectancy \>12 weeks. 6. Adequate bone marrow reserve or serious organ dysfunction 7. 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. 8. Females must have evidence of non-childbearing potential. 9. Signed and dated Informed Consent Form. Exclusion Criteria: 1. Uncontrolled pleural effusion or ascites or pericardial effusion. 2. Known and untreated, or active central nervous system metastases. 3. Active autoimmune diseases or active infectious disease 4. Known to have interstitial pneumonia or immune pneumonia 5. History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20093 6. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator. 7. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator. 8. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study. 9. History of neuropathy or mental disorders, including epilepsy and dementia.

Outcomes

Primary Outcomes

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.

Time frame: up to approximately 24 months

Secondary Outcomes

Incidence of adverse events (AEs)

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered an investigational product, which may present with symptoms, signs, disease, or laboratory abnormalities, but do not necessarily have a causality with the investigational product.

Time frame: From the first dose through 90 days post end of treatment

Objective response rate (ORR) assessed by investigator

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

Disease Control Rate (DCR)

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.

Duration of response (DOR)

Duration of response assessed by RECIST 1.1. Duration of response is defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression (PD) or death.

Time frame: up to approximately 24 months.

Overall survival (OS)

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

Data from ClinicalTrials.gov

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