Status:
RECRUITING
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Lead Sponsor:
AstraZeneca
Conditions:
Gastric Cancer
Gastroesophageal Junction Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 participant...
Detailed Description
This open-label, multi-centre study consists of individual sub studies, each evaluating the safety and tolerability of AZD0901. Sub study 1 will investigate the safety, tolerability, and anti-tumour ...
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 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 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.
Exclusion
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06219941
Start Date
December 13 2023
End Date
December 31 2026
Last Update
September 2 2025
Active Locations (51)
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1
Research Site
Orange, California, United States, 92868
2
Research Site
Palo Alto, California, United States, 94304
3
Research Site
Santa Rosa, California, United States, 95403
4
Research Site
Louisville, Kentucky, United States, 40202