NCT05116007CompletedPhase 1
Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Chemotherapy in Patients With ES-SCLC
Phase Ib Clinical Study of Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Etoposide and Carboplatin for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 31 May 2024
Brief summary (registry, in English)
Phase Ib open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with chemotherapy in patients with ES-SCLC.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 21 Sept 2021
- Start date
- 29 Mar 2021
- Primary completion date
- 4 Dec 2023
- Lead sponsor
- Akeso
- Diseases
- Lung cancer
- NCT number
- NCT05116007
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 35
- From 29 Mar 2021 to the primary completion date, 4 Dec 2023
- 1 site in 1 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.
Prior treatment
- Undergone major surgery within 30 days prior to the first dose of study treatment
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment;
Other illness
- History of prior malignancy except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
- Active infection requiring systemic therapy
- Active Hepatitis B or Hepatitis C
Other
- Active central nervous system (CNS) metastases
- Pregnant or lactating women
Who the study is looking for
- 18 to 75 years old (at the time of inform consent obtained).
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system).
- Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy.
- Have a life expectancy of at least 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator
- Has adequate organ function
- All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shun Lu Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.