NCT07063407Not yet recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 14 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Shanghai Hansoh Biomedical Co., Ltd
- Diseases
- Lung cancer
- NCT number
- NCT07063407
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From 31 Jul 2025 to the primary completion date, 30 Apr 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active autoimmune diseases or active infectious disease
- History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20093
- History of neuropathy or mental disorders, including epilepsy and dementia.
Other
- Uncontrolled pleural effusion or ascites or pericardial effusion.
- Known and untreated, or active central nervous system metastases.
- Known to have interstitial pneumonia or immune pneumonia
- 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.
Who the study is looking for
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.