Brief Summary
The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advancedat a late stage, far along unresectable or metastatic solid tumours expressing CLDN18.2.
Intervention / Treatment
- Drug: AZD0901
- Drug: 5-Fluorouracil
- Drug: Leucovorin
- Drug: l-leucovorin
- Drug: Irinotecan
- Drug: Nanoliposomal Irinotecan
- Drug: Gemcitabine
Eligibility 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 marrowsoft, spongy tissue found in bones that makes blood cells 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 adenocarcinomacancer arising from mucus-producing glands in organs 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 tumoura tissue mass that forms from groups of unhealthy cells biopsyremoval of a section of tissue to analyse for cancer cells taken at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
- No prior treatments for unresectable or metastatic disease. Prior neoadjuvant/adjuvant chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells is permitted as long as participants progressed ≥ 6 months (183 days) from the last dosethe amount of medication taken.
Sub study 3 Specific Inclusion criteria
- Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinomacancer arising from tissues that line organs (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.