Clinical Trials List
Protocol NumberALP102CT
NCT Number(ClinicalTrials.gov Identfier)NCT07107490
Active
2025-09-01 - 2028-09-30
Phase I
Recruiting5
ICD-10A00.0
Cholera due to Vibrio cholerae 01, biovar cholerae
ICD-9001.0
Cholera due to Vibrio cholerae
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
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Trial Applicant
Chugai Pharma Taiwan Ltd.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蕭慈慧 無
- Yuh-Min Chen 無
- Yung-Hung Luo 無
- Hsu-ching Huang 無
- 廖映庭 無
- 趙恒勝 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YEN-HSIANG HUANG Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
- 李柏昕 Division of Thoracic Medicine
- TSUNG -YING YANG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 枋岳甫 Division of Hematology & Oncology
- 吳浩銘 無
- 徐禀智 無
- 黃世緯 無
- 林定佑 Division of Hematology & Oncology
- 吳教恩 Division of Hematology & Oncology
- Chih-Hsi Kuo 無
- Chien-Ying Liu 無
- Shih-Hong Li Division of Hematology & Oncology
- 黃宗楨 無
- 邱立忠 無
- Fu-Tsai Chung 無
- Chih-Liang Wang 無
- 柯皓文 無
- Chih-Hung Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chien-Chung Lin
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Extensive Stage Small Cell Lung Cancer
Objectives
Main Objectives
Part 1: Dose Escalation
⚫Evaluate the safety and tolerability of ALPS12 combined with obinutuzumab as pre-treatment
⚫Determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for the extension phase, and the dosing regimen for ALPS12 combined with obinutuzumab as pre-treatment
⚫Evaluate the pharmacokinetic (PK) characteristics of ALPS12 combined with obinutuzumab as pre-treatment
⚫Investigate the immunogenicity of ALPS12 combined with obinutuzumab as pre-treatment
Part 2: Extension
⚫Evaluate the preliminary antitumor activity of different doses of ALPS12 combined with obinutuzumab as pre-treatment, determined by tumor assessment, in patients with metastatic small cell lung cancer (SCLC)
⚫Evaluate the safety and tolerability of different doses of ALPS12 combined with obinutuzumab as pre-treatment
⚫Determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for ALPS12 combined with obinutuzumab as pre-treatment Recommended dose (RP2D) and dosing regimen for the second phase of pre-treatment.
Test Drug
Injectable solution
Active Ingredient
ALPS12
1013004400
1013004400
Dosage Form
27D
27D
27D
Dosage
80mg/ml
1000 mg/40 mL (25 mg/mL)
1000 mg/40 mL (25 mg/mL)
Endpoints
Part 1: Dose Escalation Section
⚫Incidence, nature, and severity of adverse events (AEs) (according to NCI CTCAE v.5.0 classification), CRS and immune effector cell-related neurotoxic syndromes (ICANS) are classified according to the ASTCT consensus grading criteria.
⚫Nature and frequency of dose-limiting toxicities (DLTs), AEs, PKs, and pharmacodynamic properties.
⚫Serious ALPS12 concentrations and their PK parameters, including maximum serum concentration (Cmax) and area under the plasma concentration-time curve (AUC).
⚫Incidence of ALPS12 anti-antibody (ADA) and its impact on ALPS12 exposure.
Part 2: Extended Section
⚫Objective response, defined as a confirmed complete response (CR) or partial response (PR) conforming to RECIST v.1.1, as determined by the trial administrator.
⚫Incidence, nature, and severity of AEs (according to NCI CTCAE v.5.0 classification), CRS and ICANS. Then classify according to the ASTCT consensus classification standard.
⚫Incidence, nature, and severity of adverse events (AEs) (according to NCI CTCAE v.5.0 classification), CRS and immune effector cell-related neurotoxic syndromes (ICANS) are classified according to the ASTCT consensus grading criteria.
⚫Nature and frequency of dose-limiting toxicities (DLTs), AEs, PKs, and pharmacodynamic properties.
⚫Serious ALPS12 concentrations and their PK parameters, including maximum serum concentration (Cmax) and area under the plasma concentration-time curve (AUC).
⚫Incidence of ALPS12 anti-antibody (ADA) and its impact on ALPS12 exposure.
Part 2: Extended Section
⚫Objective response, defined as a confirmed complete response (CR) or partial response (PR) conforming to RECIST v.1.1, as determined by the trial administrator.
⚫Incidence, nature, and severity of AEs (according to NCI CTCAE v.5.0 classification), CRS and ICANS. Then classify according to the ASTCT consensus classification standard.
Inclution Criteria
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
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
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)
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)
The Estimated Number of Participants
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Taiwan
14 participants
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Global
122 participants
