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 advanced unresectable or metastatic solid tumours expressing CLDN18.2.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs. — 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation. To investigate the safety and tolerability, of AZD0901 monotherapy or in combination with anti-cancer agents in particpants with advanced or metastatic solid tumours expressing CLDN18.2.
Objective Response Rate (ORR). — From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years). Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR) as determined by the Investigator at local site as per RECIST v1.1.
Trial sites (52)
Facility
City
Region
Status
Research Site
Orange
California
Recruiting
Research Site
Palo Alto
California
Recruiting
Research Site
Santa Rosa
California
Recruiting
Research Site
Louisville
Kentucky
Recruiting
Research Site
Commack
New York
Recruiting
Research Site
Providence
Rhode Island
Recruiting
Research Site
Houston
Texas
Recruiting
Research Site
Melbourne
Australia
Recruiting
Research Site
Murdoch
Australia
Recruiting
Research Site
Randwick
Australia
Recruiting
Research Site
Kingston
Ontario
Withdrawn
Research Site
Toronto
Ontario
Recruiting
Research Site
Montreal
Quebec
Recruiting
Research Site
Sherbrooke
Quebec
Recruiting
Research Site
Changsha
China
Not Yet Recruiting
Research Site
Chengdu
China
Not Yet Recruiting
Research Site
Tbilisi
Georgia
Recruiting
Research Site
Chūōku
Japan
Recruiting
Research Site
Kashiwa
Japan
Recruiting
Research Site
Kitaadachi-gun
Japan
Recruiting
Research Site
Kōtoku
Japan
Recruiting
Research Site
Nagoya
Japan
Recruiting
Research Site
Osakasayama-shi
Japan
Recruiting
Research Site
George Town
Malaysia
Recruiting
Research Site
Johor Bahru
Malaysia
Completed
Research Site
Kuala Lumpur
Malaysia
Recruiting
Research Site
Kuala Selangor
Malaysia
Recruiting
Research Site
Kuching
Malaysia
Recruiting
Research Site
Chisinau
Moldova
Recruiting
Research Site
Krakow
Poland
Recruiting
Research Site
Warsaw
Poland
Recruiting
Research Site
Bukit Merah
Singapore
Recruiting
Research Site
Singapore
Singapore
Recruiting
Research Site
Singapore
Singapore
Recruiting
Research Site
Singapore
Singapore
Recruiting
Research Site
Gyeonggi-do
South Korea
Recruiting
Research Site
Seoul
South Korea
Recruiting
Research Site
Seoul
South Korea
Recruiting
Research Site
Seoul
South Korea
Recruiting
Research Site
Seoul
South Korea
Recruiting
+ 12 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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