Clinical Trials List
Protocol NumberD9800C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06219941
Active
2023-11-01 - 2027-12-31
Phase II
Recruiting5
ICD-10C16.0
Malignant neoplasm of cardia
ICD-10C7A.092
Malignant carcinoid tumor of the stomach
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9151.0
Malignant neoplasm of cardia of stomach
A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/23
Investigators and Locations
Co-Principal Investigator
- 王秀慈 Division of Hematology & Oncology
- 陳珈妤 Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hung-Chih Hsu Division of Hematology & Oncology
- Ming-Mo Hou Division of Hematology & Oncology
- Po-Jung Su Division of Hematology & Oncology
- Wen-Chi Chou Division of Hematology & Oncology
- Tsai-Sheng Yang Division of Hematology & Oncology
- Wen-Chi Shen Division of Hematology & Oncology
- 黃文冠 Division of Hematology & Oncology
- Yung-Chia Kao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jeng-Shiun Du Division of Hematology & Oncology
- Yung-Yeh Su Division of Hematology & Oncology
- Wang Yao-Kuang Digestive System Department
- Hui-Ching Wang Division of Hematology & Oncology
- Tsung-Jang Yeh Division of Hematology & Oncology
- Li-Tzong Chen Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 姜乃榕
- Shao-Jung Hsu Digestive System Department
- 林泰祺
- 翁章旂 Division of Ophthalmology
- 陳宥任 Digestive System Department
- Chung-Pin Li
- Hung-Yuan Yu
- Chien-An Liu
- San-Chi Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yan-Shen Shan
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Pancreatic Ductal Adenocarcinoma
Objectives
This study investigates the safety and tolerability of AZD0901 as monotherapy or in combination with an anticancer drug in subjects with advanced or metastatic solid tumors exhibiting CLDN18.2.
The study evaluates the preliminary antitumor activity of AZD0901 as monotherapy or in combination with an anticancer drug in subjects with advanced or metastatic solid tumors exhibiting CLDN18.2 (assessed by objective response rate [ORR]).
Test Drug
Frozen Crystal Injection
Active Ingredient
AZD0901
Dosage Form
Lyophiliszed Injection
Dosage
50mg (10mg/ml)
Endpoints
• Investigate the safety and tolerability of AZD0901 as monotherapy or in combination with an anticancer drug in subjects with advanced or metastatic solid tumors exhibiting CLDN18.2.
• Evaluate the preliminary antitumor activity (assessed by objective response rate [ORR]) of AZD0901 as monotherapy or in combination with an anticancer drug in subjects with advanced or metastatic solid tumors exhibiting CLDN18.2.
• Evaluate the preliminary antitumor activity (assessed by objective response rate [ORR]) of AZD0901 as monotherapy or in combination with an anticancer drug in subjects with advanced or metastatic solid tumors exhibiting CLDN18.2.
Inclution Criteria
The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.
Master Inclusion Criteria applicable to all sub studies:
Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
Participants who are CLDN18.2 positive.
Must have at least one measurable lesion according to RECIST v1.1.
ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
Predicted life expectancy of ≥ 12 weeks.
Adequate organ and bone marrow function as defined by protocol.
Body weight > 35 kg.
Participants are willing to comply with contraception requirements.
Sub study 1 Specific Inclusion criteria:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
Advanced or metastatic GC/GEJC.
Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
Sub study 2 Specific Inclusion criteria:
Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
Availability of an archival sample or a fresh tumour biopsy taken at screening.
No prior treatments for unresectable or metastatic disease. Prior neoadjuvant/adjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.
Sub study 3 Specific Inclusion criteria
Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).
Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
Master Inclusion Criteria applicable to all sub studies:
Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
Participants who are CLDN18.2 positive.
Must have at least one measurable lesion according to RECIST v1.1.
ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
Predicted life expectancy of ≥ 12 weeks.
Adequate organ and bone marrow function as defined by protocol.
Body weight > 35 kg.
Participants are willing to comply with contraception requirements.
Sub study 1 Specific Inclusion criteria:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
Advanced or metastatic GC/GEJC.
Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
Sub study 2 Specific Inclusion criteria:
Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
Availability of an archival sample or a fresh tumour biopsy taken at screening.
No prior treatments for unresectable or metastatic disease. Prior neoadjuvant/adjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.
Sub study 3 Specific Inclusion criteria
Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).
Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
Exclusion Criteria
Master Exclusion Criteria applicable to all sub studies:
Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
Participants with clinically significant ascites that require drainage.
A history of drug-induced non-infectious ILD/pneumonitis.
Central nervous system metastases or CNS pathology.
Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.
History of another primary malignancy.
Prior exposure to any MMAE-based ADC.
Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.
Sub study 1 Specific Exclusion criteria:
Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC unless they have failed/not tolerated/or are not eligible for standard anti-HER2 therapy, where available.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
The use of concomitant medications known to prolong the QT/QTc interval.
Sub study 2 Specific Exclusion criteria:
Known DPD enzyme deficiency based on local testing where testing is SoC.
Use of strong inhibitor or inducer of UGT1A1.
Use of strong inhibitors or inducers of CYP3A4.
Known homozygous for the UGT1A1*28 allele based on local testing where testing is SoC.
Sub study 3 Specific Exclusion criteria
• Clinically significant biliary obstruction that has not resolved before enrollment.
Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
Participants with clinically significant ascites that require drainage.
A history of drug-induced non-infectious ILD/pneumonitis.
Central nervous system metastases or CNS pathology.
Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.
History of another primary malignancy.
Prior exposure to any MMAE-based ADC.
Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.
Sub study 1 Specific Exclusion criteria:
Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC unless they have failed/not tolerated/or are not eligible for standard anti-HER2 therapy, where available.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
The use of concomitant medications known to prolong the QT/QTc interval.
Sub study 2 Specific Exclusion criteria:
Known DPD enzyme deficiency based on local testing where testing is SoC.
Use of strong inhibitor or inducer of UGT1A1.
Use of strong inhibitors or inducers of CYP3A4.
Known homozygous for the UGT1A1*28 allele based on local testing where testing is SoC.
Sub study 3 Specific Exclusion criteria
• Clinically significant biliary obstruction that has not resolved before enrollment.
The Estimated Number of Participants
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Taiwan
35 participants
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Global
370 participants
