Clinical trial · Interventional
A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
NCT07107490CI-TRIAL-00102608recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALPS12 | Drug | — | UNRESOLVED |
| obinutuzumab | Drug | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation part
- description
- Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to determine the MTD by evaluating DLTs in patients with extensive stage small cell lung cancer.
- interventionNames
- Drug: ALPS12
- Drug: obinutuzumab
- type
- EXPERIMENTAL
- label
- Expansion part
- description
- Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect.
- interventionNames
- Drug: ALPS12
- Drug: obinutuzumab
Primary outcomes (4)
- measure
- All part : Adverse events of ALPS12[safety and tolerability]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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 Exclusion Criteria: * 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 amylase/lipase), and/or patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.