Clinical Trials List
Protocol NumberALE.P03.01
NCT Number(ClinicalTrials.gov Identfier)NCT2025-521441-24-00
Active
2025-08-18 - 2030-06-30
Phase I/II
Recruiting4
ICD-10C7A.1
Malignant poorly differentiated neuroendocrine tumors
ICD-10C7A.8
Other malignant neuroendocrine tumors
ICD-10C7B.09
Secondary carcinoid tumors of other sites
ICD-10C7B.1
Secondary Merkel cell carcinoma
ICD-10C7B.8
Other secondary neuroendocrine tumors
ICD-10C80.0
Disseminated malignant neoplasm, unspecified
ICD-10D3A.8
Other benign neuroendocrine tumors
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9199.0
Disseminated malignant neoplasm
A phase 1/2, open-label, multicenter trial of ALE.P03 (Claudin-1 targeted antibody-drug complex) monotherapy in selected adult patients with advanced or metastatic CLDN1+ solid tumors.
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Parexel International Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/22
Investigators and Locations
Co-Principal Investigator
- Shang-Hung Chen Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- 黃盈慈 Division of Hematology & Oncology
- Chih-Chieh Yen Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- 黃怡璇 Division of Hematology & Oncology
- 黃怡菁 Division of Hematology & Oncology
- 鍾秉軒 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kai-Ling Lee Division of Thoracic Medicine
- Shang-Fu Hsu Division of Thoracic Medicine
- Mei-Chuan Chen Division of Thoracic Medicine
- 高冠鈞 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Chi Lin
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
吳教恩
Co-Principal Investigator
- Wen-Cheng Chang Division of Hematology & Oncology
- Hung-Chih Hsu Division of Hematology & Oncology
- 陳冠任 Division of Hematology & Oncology
- Ming-Mo Hou Division of Hematology & Oncology
- Wen-Chi Chou Division of Hematology & Oncology
- Po-Jung Su Division of Hematology & Oncology
- Chia-Hsun Hsieh Division of Hematology & Oncology
- 黃文冠 Division of Hematology & Oncology
- Chun-Bing Chen Division of Hematology & Oncology
- 賴盈傑 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced or metastatic CLDN1+ solid tumors
Objectives
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetic (PK), PD, preliminary antitumor activity, and confirmation of RP2D of ALE.P03 monotherapy in adult patients with specific solid tumors.
Test Drug
ALE.P03
Active Ingredient
ALE.P03
Dosage Form
Frozen Crystal Powder
Dosage
140 mg/7 mL
Endpoints
Assess the safety and tolerability of ALE.P03 (Phase 1 dose escalation)
Determine the Phase 2 recommended dose (RP2D) of ALE.P03 (Phase 1 RDE)
● Incidence of DLT
● Incidence and severity of AE and SAE
● Clinically significant changes in laboratory values, vital signs, and ECG
● Tolerability: Dose interruption and dose intensity
● Preliminary efficacy parameters according to RECIST 1.1*:
o ORR (defined as CR rate + PR rate)
o DoR
Note: These parameters may be subgrouped based on CLDN1 presentation and tumor type.
Assess the antitumor activity of ALE.P03 (Phase 2)
Efficacy parameters according to RECIST 1.1*:
● ORR
● DoR
Note: These parameters may be subgrouped based on CLDN1 presentation and tumor type.
Determine the Phase 2 recommended dose (RP2D) of ALE.P03 (Phase 1 RDE)
● Incidence of DLT
● Incidence and severity of AE and SAE
● Clinically significant changes in laboratory values, vital signs, and ECG
● Tolerability: Dose interruption and dose intensity
● Preliminary efficacy parameters according to RECIST 1.1*:
o ORR (defined as CR rate + PR rate)
o DoR
Note: These parameters may be subgrouped based on CLDN1 presentation and tumor type.
Assess the antitumor activity of ALE.P03 (Phase 2)
Efficacy parameters according to RECIST 1.1*:
● ORR
● DoR
Note: These parameters may be subgrouped based on CLDN1 presentation and tumor type.
Inclution Criteria
1) Willing and able to provide written informed consent for the clinical trial.
2) At least 18 years of age on the day the participant signs the consent form.
3) History of the following diseases and treatments:
• Histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic colorectal cancer (CRC), intrahepatic cholangiocarcinoma (iCCA), squamous non-small cell lung cancer (sqNSCLC), urothelial carcinoma (UC), or cutaneous squamous cell carcinoma (CSCC).
• Record of radiological disease exacerbation at the time of entry into the trial.
• Sufficient CLDN1 protein expression as determined by the central laboratory.
4) Tissue samples have been provided for CLDN1 analysis by the central laboratory. Tumor tissue must be collected within the baseline period (i.e., 180 days prior to trial inclusion) unless the biopsy procedure is deemed high-risk to patient safety according to the trial administrator and local guidelines. If no biopsy specimens are available, or the procedure is deemed unsafe, retained tumor tissue specimens collected more than 180 days prior may be submitted. However, the specimens should ideally be collected no later than the start date of the most recent anticancer treatment.
5) The patient must be diagnosed with measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the trial center. Measurable lesions are considered to be those where tumor progression at previously radiotherapy sites has been confirmed since the termination of the most recent anticancer treatment prior to trial inclusion has occurred.
6) A performance status score of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) scale. 7) Demonstrate adequate bone marrow and organ function as defined in Table – Bone Marrow and Organ Function. All screening laboratory assessments should be performed within 14 days prior to the start of the trial treatment. Patients must not have received red blood cell or platelet transfusions, or growth factor support, within one week prior to the screening assessment.
8) For fertile female patients, a negative blood pregnancy test should be obtained within 72 hours prior to receiving the first dose of the trial treatment. If a blood test is not suitable, a urine test may be considered.
9) During the trial period, and until 180 days after the last dose of the trial treatment, fertile female patients should be willing to use two methods of contraception, or have undergone surgical sterilization or abstain from heterosexual intercourse. Fertility-capable patients are defined as those who have not undergone surgical sterilization and have not menstruated for more than one year.
10) From the first dose of the trial treatment until 90 days after the last dose of the trial treatment, male patients should agree to use appropriate methods of contraception and avoid sperm donation.
2) At least 18 years of age on the day the participant signs the consent form.
3) History of the following diseases and treatments:
• Histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic colorectal cancer (CRC), intrahepatic cholangiocarcinoma (iCCA), squamous non-small cell lung cancer (sqNSCLC), urothelial carcinoma (UC), or cutaneous squamous cell carcinoma (CSCC).
• Record of radiological disease exacerbation at the time of entry into the trial.
• Sufficient CLDN1 protein expression as determined by the central laboratory.
4) Tissue samples have been provided for CLDN1 analysis by the central laboratory. Tumor tissue must be collected within the baseline period (i.e., 180 days prior to trial inclusion) unless the biopsy procedure is deemed high-risk to patient safety according to the trial administrator and local guidelines. If no biopsy specimens are available, or the procedure is deemed unsafe, retained tumor tissue specimens collected more than 180 days prior may be submitted. However, the specimens should ideally be collected no later than the start date of the most recent anticancer treatment.
5) The patient must be diagnosed with measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the trial center. Measurable lesions are considered to be those where tumor progression at previously radiotherapy sites has been confirmed since the termination of the most recent anticancer treatment prior to trial inclusion has occurred.
6) A performance status score of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) scale. 7) Demonstrate adequate bone marrow and organ function as defined in Table – Bone Marrow and Organ Function. All screening laboratory assessments should be performed within 14 days prior to the start of the trial treatment. Patients must not have received red blood cell or platelet transfusions, or growth factor support, within one week prior to the screening assessment.
8) For fertile female patients, a negative blood pregnancy test should be obtained within 72 hours prior to receiving the first dose of the trial treatment. If a blood test is not suitable, a urine test may be considered.
9) During the trial period, and until 180 days after the last dose of the trial treatment, fertile female patients should be willing to use two methods of contraception, or have undergone surgical sterilization or abstain from heterosexual intercourse. Fertility-capable patients are defined as those who have not undergone surgical sterilization and have not menstruated for more than one year.
10) From the first dose of the trial treatment until 90 days after the last dose of the trial treatment, male patients should agree to use appropriate methods of contraception and avoid sperm donation.
Exclusion Criteria
1) SqNSCLC and CSCC: Tumors diagnosed with predominantly non-squamous histological outcomes (e.g., adenosquamous carcinoma) or adenocarcinoma.
2) Received antitumor therapy within the specified timeframe prior to trial treatment.
3) Patients with active keratitis or corneal ulcers. Patients with superficial punctate keratitis are permitted if the trial administrator deems the disease adequately treated.
4) Known homozygous status for the UGT1A1*28 paired gene.
5) Diagnosed with a rapidly progressing disease by the trial administrator or designated personnel.
6) Diagnosed and/or treated for an additional second malignancy within 3 years prior to Day 1 (C) of Cycle 1, excluding: basal cell carcinoma of the skin that has received curative treatment, squamous cell carcinoma of the skin, cervical carcinoma in situ that has undergone curative resection (not applicable to patients with CSCC at the time of enrollment), and breast carcinoma in situ that has undergone curative resection. Other exceptions may be considered after consultation with a medical monitor or designated personnel.
7) Any of the following cardiac conditions:
• A mean resting QT interval corrected using Fridericia’s formula (QTcF) > 470 ms from three repeated electrocardiograms (ECGs).
• Any factor that increases the risk of QT interval prolongation, shortening, or arrhythmic events, such as hypokalemia, congenital long or short QT syndrome, long QT syndrome, familial short QT syndrome, or a family history of unexplained sudden death before age 40, or the use of any medication known to prolong or shorten the QT interval.
• Resting ECG shows any clinically significant abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second- or third-degree atrioventricular block, and clinically significant sinoatrial node dysfunction not treated with a pacemaker.
8) Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
9) Previous allogeneic tissue/solid organ transplantation.
10) History of (non-infectious) interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid treatment, or current symptomatic or clinically significant non-infectious pneumonia requiring steroid and/or immunosuppressive therapy.
11) For sqNSCLC patients: Received lung radiation therapy at a dose >30 Gy within 6 months prior to the first dose of trial treatment.
12) Clinically significant gastrointestinal bleeding (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade 3 or higher) within 30 days prior to screening.
13) Active infection requiring systemic treatment (e.g., intravenous (IV) antibiotics, antiviral drugs, or antifungal drugs).
14) Past or current evidence of any medical condition, treatment, or laboratory test result that, as determined by the trial administrator, may confound the clinical trial results, interfere with the patient's participation throughout the trial, or result in participation that is not in the patient's best interest.
15) Pregnant, breastfeeding, or expecting to conceive during the clinical trial period from screening consultation until 180 days after the last dose of trial treatment, or expecting to impregnate another person during the period from screening consultation until 90 days after the last dose of trial treatment.
16) Individuals with untreated chronic hepatitis B, or chronic HBV carriers at screening with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or ≥ 2500 copies/mL).
17) Individuals with active hepatitis C virus (HCV) infection. Note: Patients with a negative HCV antibody test result at screening, or a positive HCV antibody test result at screening but a subsequent negative HCV ribonucleic acid test result, are eligible.
18) Individuals with untreated human immunodeficiency virus (HIV) infection, if known.
19) Individuals who have received an active vaccine within 30 days prior to the scheduled start of experimental treatment.
20) Previous treatment with an antibody-drug conjugate (ADC) containing a type I topoisomerase I (Topo-I) inhibitor as the effective drug.
21) Previous CLDN1 targeted therapy.
22) Known hypersensitivity to the investigational treatment or any excipient used in the investigational treatment formulation.
23) Patients using cytochrome P450 (CYP) 1A2 receptors with a narrow therapeutic index (e.g., theophylline, tacrine, clozapine, olanzapine, and R-warfarin) (excluding caffeine) and unable to discontinue use during the investigational treatment until 3 weeks after the last dose of ALE.PO3.
2) Received antitumor therapy within the specified timeframe prior to trial treatment.
3) Patients with active keratitis or corneal ulcers. Patients with superficial punctate keratitis are permitted if the trial administrator deems the disease adequately treated.
4) Known homozygous status for the UGT1A1*28 paired gene.
5) Diagnosed with a rapidly progressing disease by the trial administrator or designated personnel.
6) Diagnosed and/or treated for an additional second malignancy within 3 years prior to Day 1 (C) of Cycle 1, excluding: basal cell carcinoma of the skin that has received curative treatment, squamous cell carcinoma of the skin, cervical carcinoma in situ that has undergone curative resection (not applicable to patients with CSCC at the time of enrollment), and breast carcinoma in situ that has undergone curative resection. Other exceptions may be considered after consultation with a medical monitor or designated personnel.
7) Any of the following cardiac conditions:
• A mean resting QT interval corrected using Fridericia’s formula (QTcF) > 470 ms from three repeated electrocardiograms (ECGs).
• Any factor that increases the risk of QT interval prolongation, shortening, or arrhythmic events, such as hypokalemia, congenital long or short QT syndrome, long QT syndrome, familial short QT syndrome, or a family history of unexplained sudden death before age 40, or the use of any medication known to prolong or shorten the QT interval.
• Resting ECG shows any clinically significant abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second- or third-degree atrioventricular block, and clinically significant sinoatrial node dysfunction not treated with a pacemaker.
8) Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
9) Previous allogeneic tissue/solid organ transplantation.
10) History of (non-infectious) interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid treatment, or current symptomatic or clinically significant non-infectious pneumonia requiring steroid and/or immunosuppressive therapy.
11) For sqNSCLC patients: Received lung radiation therapy at a dose >30 Gy within 6 months prior to the first dose of trial treatment.
12) Clinically significant gastrointestinal bleeding (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade 3 or higher) within 30 days prior to screening.
13) Active infection requiring systemic treatment (e.g., intravenous (IV) antibiotics, antiviral drugs, or antifungal drugs).
14) Past or current evidence of any medical condition, treatment, or laboratory test result that, as determined by the trial administrator, may confound the clinical trial results, interfere with the patient's participation throughout the trial, or result in participation that is not in the patient's best interest.
15) Pregnant, breastfeeding, or expecting to conceive during the clinical trial period from screening consultation until 180 days after the last dose of trial treatment, or expecting to impregnate another person during the period from screening consultation until 90 days after the last dose of trial treatment.
16) Individuals with untreated chronic hepatitis B, or chronic HBV carriers at screening with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or ≥ 2500 copies/mL).
17) Individuals with active hepatitis C virus (HCV) infection. Note: Patients with a negative HCV antibody test result at screening, or a positive HCV antibody test result at screening but a subsequent negative HCV ribonucleic acid test result, are eligible.
18) Individuals with untreated human immunodeficiency virus (HIV) infection, if known.
19) Individuals who have received an active vaccine within 30 days prior to the scheduled start of experimental treatment.
20) Previous treatment with an antibody-drug conjugate (ADC) containing a type I topoisomerase I (Topo-I) inhibitor as the effective drug.
21) Previous CLDN1 targeted therapy.
22) Known hypersensitivity to the investigational treatment or any excipient used in the investigational treatment formulation.
23) Patients using cytochrome P450 (CYP) 1A2 receptors with a narrow therapeutic index (e.g., theophylline, tacrine, clozapine, olanzapine, and R-warfarin) (excluding caffeine) and unable to discontinue use during the investigational treatment until 3 weeks after the last dose of ALE.PO3.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
180 participants
