Phase
Condition
Gastric Cancer
Gall Bladder Cancer
Digestive System Neoplasms
Treatment
5-Fluorouracil
Irinotecan
l-leucovorin
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
AustraliaSite Not Available
Research Site
Melbourne 2158177, 3000
AustraliaActive - Recruiting
Research Site
Murdoch, WA6150
AustraliaSite Not Available
Research Site
Murdoch 8349091, WA6150
AustraliaActive - Recruiting
Research Site
Randwick, 2031
AustraliaSite Not Available
Research Site
Randwick 2208285, 2031
AustraliaActive - Recruiting
Research Site
Kingston, Ontario K7L 2V7
CanadaSite Not Available
Research Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Research Site
Kingston 5992500, Ontario 6093943 K7L 2V7
CanadaSite Not Available
Research Site
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaActive - Recruiting
Research Site
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Research Site
Sherbrooke, Quebec J1G 2E8
CanadaSite Not Available
Research Site
Montreal 6077243, Quebec 6115047 H3G 1A4
CanadaActive - Recruiting
Research Site
Sherbrooke 6146143, Quebec 6115047 J1G 2E8
CanadaActive - Recruiting
Research Site
Changsha 1815577, 410013
ChinaSite Not Available
Research Site
Chengdu 1815286, 610041
ChinaSite Not Available
Research Site
Tbilisi, 0112
GeorgiaSite Not Available
Research Site
Tbilisi 611717, 0112
GeorgiaActive - Recruiting
Research Site
Chuo-ku, 104-0045
JapanSite Not Available
Research Site
Chūōku 10262791, 104-0045
JapanActive - Recruiting
Research Site
Kashiwa, 227-8577
JapanSite Not Available
Research Site
Kashiwa 1859924, 227-8577
JapanActive - Recruiting
Research Site
Kitaadachi-gun, 362-0806
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanSite Not Available
Research Site
Kōtoku 2128852, 135-8550
JapanActive - Recruiting
Research Site
Nagoya 1856057, 464-8681
JapanActive - Recruiting
Research Site
Nagoya-shi, 464-8681
JapanSite Not Available
Research Site
Osakasayama-shi, 589-8511
JapanActive - Recruiting
Research Site
Gyeonggi-do, 13620
Korea, Republic ofSite Not Available
Research Site
Seoul, 06351
Korea, Republic ofSite Not Available
Research Site
George Town, 10450
MalaysiaSite Not Available
Research Site
George Town 1735106, 10450
MalaysiaActive - Recruiting
Research Site
Johor Bahru, 81100
MalaysiaSite Not Available
Research Site
Johor Bahru 1732752, 81100
MalaysiaCompleted
Research Site
Kuala Lumpur, 59100
MalaysiaSite Not Available
Research Site
Kuala Lumpur 1735161, 59100
MalaysiaActive - Recruiting
Research Site
Kuala Selangor 1732891, 62250
MalaysiaActive - Recruiting
Research Site
Kuching, 93586
MalaysiaSite Not Available
Research Site
Kuching 1735634, 93586
MalaysiaActive - Recruiting
Research Site
Selangor, 62250
MalaysiaSite Not Available
Research Site
Chisinau 618426, MD-2025
MoldovaActive - Recruiting
Research Site
Chisinau, MD-2025
Moldova, Republic ofSite Not Available
Research Site
Krakow 3094802, 31-501
PolandActive - Recruiting
Research Site
Kraków, 31-501
PolandSite Not Available
Research Site
Warsaw 756135, 02-034
PolandActive - Recruiting
Research Site
Warszawa, 02-034
PolandSite Not Available
Research Site
Bukit Merah, 169610
SingaporeActive - Recruiting
Research Site
Singapore, 119074
SingaporeSite Not Available
Research Site
Singapore 1880252, 308433
SingaporeActive - Recruiting
Research Site
Gyeonggi-do 6363696, 13620
South KoreaActive - Recruiting
Research Site
Seoul 1835848, 05505
South KoreaActive - Recruiting
Research Site
Barcelona, 08035
SpainSite Not Available
Research Site
Barcelona 3128760, 08035
SpainActive - Recruiting
Research Site
Madrid, 28007
SpainSite Not Available
Research Site
Madrid 3117735, 28007
SpainActive - Recruiting
Research Site
Kaohsiung, 80756
TaiwanSite Not Available
Research Site
Kaohsiung City 1673820, 80756
TaiwanActive - Recruiting
Research Site
Taichung, 404
TaiwanSite Not Available
Research Site
Taichung 1668399, 404
TaiwanActive - Recruiting
Research Site
Tainan 1668355, 70403
TaiwanActive - Recruiting
Research Site
Tainan City, 70403
TaiwanSite Not Available
Research Site
Tainan City 1668355, 70403
TaiwanSite Not Available
Research Site
Taipei, 11217
TaiwanSite Not Available
Research Site
Taipei 1668341, 11217
TaiwanActive - Recruiting
Research Site
Taipei City, 11217
TaiwanSite Not Available
Research Site
Taoyuan, 00333
TaiwanSite Not Available
Research Site
Taoyuan District 1667905, 00333
TaiwanActive - Recruiting
Research Site
Glasgow, G12 0YN
United KingdomSite Not Available
Research Site
Glasgow 2648579, G12 0YN
United KingdomSite Not Available
Research Site
Leeds, LS9 7TF
United KingdomSite Not Available
Research Site
Leeds 2644688, LS9 7TF
United KingdomSite Not Available
Research Site
London, NW3 2QG
United KingdomSite Not Available
Research Site
London 2643743, NW3 2QG
United KingdomSite Not Available
Research Site
Oxford, OX3 7LE
United KingdomSite Not Available
Research Site
Oxford 2640729, OX3 7LE
United KingdomSite Not Available
Research Site
Orange, California 92868
United StatesSite Not Available
Research Site
Palo Alto, California 94304
United StatesSite Not Available
Research Site
Santa Rosa, California 95403
United StatesSite Not Available
Research Site
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Research Site
Palo Alto 5380748, California 5332921 94304
United StatesActive - Recruiting
Research Site
Santa Rosa 5393287, California 5332921 95403
United StatesActive - Recruiting
Research Site
Louisville, Kentucky 40202
United StatesSite Not Available
Research Site
Louisville 4299276, Kentucky 6254925 40202
United StatesActive - Recruiting
Research Site
Commack, New York 11725
United StatesSite Not Available
Research Site
Commack 5113412, New York 5128638 11725
United StatesActive - Recruiting
Research Site
Providence, Rhode Island 02903
United StatesSite Not Available
Research Site
Providence 5224151, Rhode Island 5224323 02903
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesSite Not Available
Research Site
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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