Clinical trial NCT06921928: Study for AZD4360 in Participants With Advanced Solid Tumours
Official title: A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Biliary Tract Cancer
Pancreatic Ductal Adenocarcinoma
Keywords: Gastric Cancer
Gastroesophageal Junction Cancer
Biliary Tract Cancer
Pancreatic Ductal Adenocarcinoma
Advanced Solid Tumours
AZD4360
Claudin 18.2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.


Eligibility criteria: Inclusion Criteria:

1. Participant must be ≥ 18 at the time of signing the ICF.
2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
3. Minimum life expectancy of 12 weeks in the opinion of the Investigator.

4 Adequate organ and marrow function, as defined by protocol.

5. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.

6. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.

7. Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.

8. At least one measurable lesion according to RECIST v1.1.

Exclusion Criteria:

1. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
2. 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.
3. Participants with clinically significant ascites that require drainage.
4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
5. With spinal cord compression or with high risk of paralysis.
6. History of non-infectious interstitial lung disease/pneumonitis.
7. Participant has cardiac abnormalities, as defined by protocol.
8. History of another primary malignancy within 2 years prior to screening.
9. Known serologic status reflecting active hepatitis B or hepatitis C.
10. Known HIV infection that is not well controlled.
11. Active tuberculosis infection.

Primary outcomes:
measure: Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
timeFrame: Through study completion, up to approximately 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Through study completion, up to approximately 2 years
measure: Duration of Response (DoR)
timeFrame: Through study completion, up to approximately 2 years
measure: Disease Control Rate (DCR)
timeFrame: Through study completion, up to approximately 2 years
measure: Progression Free Survival (PFS)
timeFrame: Through study completion, up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Through study completion, up to approximately 2 years
measure: Plasma pharmacokinetics (PK) parameters of AZD4360: Plasma concentration
timeFrame: Through study completion, up to approximately 2 years
measure: Plamsa PK parameters of AZD4360, total antibody and other analytes: Area Under Curve (AUC)
timeFrame: Through study completion, up to approximately 2 years
measure: Plasma PK parameters of AZD4360, total antibody and other analytes: Maximum plasma concentration (Cmax)
timeFrame: Through study completion, up to approximately 2 years
measure: Plasma PK parameters of AZD4360, total antibody and other analytes: Time to maximum plasma concentration (tmax)
timeFrame: Through study completion, up to approximately 2 years
measure: Plasma PK parameters of AZD4360, total antibody and other analytes: Clearance
timeFrame: Through study completion, up to approximately 2 years
measure: Plasma PK parameters of AZD4360, total antibody and other analytes: Half-life
timeFrame: Through study completion, up to approximately 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Houston
country: United States
facility: Research Site
state: Texas
city: Chengdu
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
Study officials:
References: