Phase
Condition
Pancreatic Disorders
Gall Bladder Cancer
Stomach Cancer
Treatment
Irinotecan
Gemcitabine
5-Fluorouracil
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 signingthe 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 weeksprior 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. Priorneoadjuvant/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 ofbiliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) andgallbladder carcinoma (NOTE: Ampullary cancers are not eligible).
Documented radiographic or clinical disease progression on or after at least oneprior regimen and maximum 2 prior lines of systemic treatment for unresectable ormetastatic disease.
Master Exclusion Criteria applicable to all sub studies:
Unstable or active peptic ulcer disease or digestive tract bleeding including butnot limited to clinically significant bleeding in the setting of prior CLDN18.2directed 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 monoclonalantibody.
Exclusion
Sub study 1 Specific Exclusion criteria:
Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) orindeterminate GC/GEJC unless they have failed/not tolerated/or are not eligible forstandard 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 isSoC.
Sub study 3 Specific Exclusion criteria
• Clinically significant biliary obstruction that has not resolved before enrollment.
Study Design
Study Description
Connect with a study center
Research Site
Melbourne, 3000
AustraliaActive - Recruiting
Research Site
Murdoch, WA6150
AustraliaActive - Recruiting
Research Site
Randwick, 2031
AustraliaActive - Recruiting
Research Site
Kingston, Ontario K7L 2V7
CanadaSite Not Available
Research Site
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Research Site
Montreal, Quebec H3G 1A4
CanadaActive - Recruiting
Research Site
Sherbrooke, Quebec J1G 2E8
CanadaActive - Recruiting
Research Site
Tbilisi, 0112
GeorgiaActive - Recruiting
Research Site
Chuo-ku, 104-0045
JapanActive - Recruiting
Research Site
Kashiwa, 227-8577
JapanActive - Recruiting
Research Site
Kitaadachi-gun, 362-0806
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanActive - Recruiting
Research Site
Nagoya-shi, 464-8681
JapanActive - Recruiting
Research Site
Osakasayama-shi, 589-8511
JapanActive - Recruiting
Research Site
Seoul, 03080
Korea, Republic ofActive - Recruiting
Research Site
George Town, 10450
MalaysiaActive - Recruiting
Research Site
Johor Bahru, 81100
MalaysiaActive - Recruiting
Research Site
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Research Site
Kuching, 93586
MalaysiaActive - Recruiting
Research Site
Selangor, 62250
MalaysiaActive - Recruiting
Research Site
Chisinau, MD-2025
Moldova, Republic ofActive - Recruiting
Research Site
Kraków, 31-501
PolandActive - Recruiting
Research Site
Warszawa, 02-034
PolandActive - Recruiting
Research Site
Bukit Merah, 169610
SingaporeActive - Recruiting
Research Site
Singapore, 308433
SingaporeActive - Recruiting
Research Site
Barcelona, 08035
SpainActive - Recruiting
Research Site
Madrid, 28007
SpainActive - Recruiting
Research Site
Kaohsiung, 80756
TaiwanActive - Recruiting
Research Site
Taichung, 404
TaiwanActive - Recruiting
Research Site
Tainan City, 70403
TaiwanActive - Recruiting
Research Site
Taipei City, 11217
TaiwanActive - Recruiting
Research Site
Taoyuan, 00333
TaiwanActive - Recruiting
Research Site
Glasgow, G12 0YN
United KingdomSite Not Available
Research Site
Leeds, LS9 7TF
United KingdomSite Not Available
Research Site
London, NW3 2QG
United KingdomSite Not Available
Research Site
Oxford, OX3 7LE
United KingdomSite Not Available
Research Site
Orange, California 92868
United StatesActive - Recruiting
Research Site
Palo Alto, California 94304
United StatesActive - Recruiting
Research Site
Santa Rosa, California 95403
United StatesActive - Recruiting
Research Site
Louisville, Kentucky 40202
United StatesActive - Recruiting
Research Site
Commack, New York 11725
United StatesActive - Recruiting
Research Site
Providence, Rhode Island 02903
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
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