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New treatment option for Extensive Stage Small Cell Lung Cancer
Official title A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
ClinicalTrials.gov ID: NCT07107490
What this study is testing
What is ALPS12?
ALPS12 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive stage small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged \>18 years at time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Histologically documented extensive stage small cell lung cancer
- Disease recurrence documented after at least one prior systemic therapy.
- Confirmed availability of representative archival tumor specimens or fresh tumor specimen.
You likely can't join if
- Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
- History or complication of clinically significant autoimmune disease
- a positive HIV antibody test at screening
- Active hepatitis B or hepatitis C
- Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies
- Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to...
See the full eligibility criteria
- Aged \>18 years at time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Histologically documented extensive stage small cell lung cancer
- Disease recurrence documented after at least one prior systemic therapy.
- Confirmed availability of representative archival tumor specimens or fresh tumor specimen.
- Measurable disease per RECIST v.1.1.
- Adequate hematologic and end organ function
- Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
- History or complication of clinically significant autoimmune disease
- a positive HIV antibody test at screening
- Active hepatitis B or hepatitis C
- Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies
- Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to the first administration of the investigational drug.
- History of Grade 4 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase)
- Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum...
- Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug
- History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease
- Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
- Kashiwa, Chiba, Japan
- Tōon, Ehime, Japan
- Sakai, Osaka, Japan
- Niigata, Japan
- Changhua, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong; Kashiwa, Chiba, Japan; Tōon, Ehime, Japan; Sakai, Osaka, Japan; Niigata, Japan; Changhua, Taiwan. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.