Phase 1 Study of HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hansoh Biomedical Co., Ltd
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
HS-20093 in combination with Adebrelimab
DrugHS-20093 in combination with Adebrelimab will be administered intravenously every 3 weeks until disease progression or other criteria for termination of treatment are met.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: HS-20093 and AdebrelimabExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
up to approximately 24 monthsSecondary outcomes
1
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 treatment2
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 months3
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.4
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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