NCT06219941|RecruitingPhase 2FDA Drug

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)

AstraZeneca ClinicalTrials.gov

Compare

1 other identifier

D9800C00001

Study Type

interventional

Target

224

Locations

14 countries

Sites

Timeline

RegisteredJan 2024

StartedDec 2023

CompletionSep 2027

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 advanced unresectable or metastatic solid tumours expressing CLDN18.2.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

224

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline

17mo left

Started Dec 2023

Typical duration for phase_2 gastric-cancer

Geographic Reach

14 countries

52 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress63%

Dec 2023Sep 2027

First Submitted

Initial submission to the registry

November 21, 2023

Completed

22 days until next milestone

Study Start

First participant enrolled

December 13, 2023

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2026

Expected

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

November 21, 2023

Last Update Submit

February 11, 2026

Conditions

Gastric Cancer Gastroesophageal Junction Cancer Biliary Tract Cancer Pancreatic Ductal Adenocarcinoma

Keywords

Gastric cancerGastroesophageal junction cancerPancreatic Ductal adenocarcinomaBiliary Tract CancerPhase IIClaudin 18.2AZD0901

Outcome Measures

Primary Outcomes (2)

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.
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.
30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.
Objective Response Rate (ORR).
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.
From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Secondary Outcomes (9)

Overall Survival (OS)
From date of first dose/randomisation until the date of death due to any cause (approximately 2 years).
Progression Free Survival (PFS)
From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 2 years).
Duration of Response (DoR)
From the date of first documented confirmed response until date of documented progression (approximately 2 years).
Disease control rate (DCR)
Up to 11 weeks post date of first dose/randomisation
Percentage change in tumor size
From start through to study completion.
+4 more secondary outcomes

Study Arms (3)

Sub Study 1 - AZD0901 MONOTHERAPY

EXPERIMENTAL

Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.

Drug: AZD0901

Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA

EXPERIMENTAL

Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents

Drug: AZD0901Drug: 5-FluorouracilDrug: LeucovorinDrug: l-leucovorinDrug: IrinotecanDrug: Nanoliposomal IrinotecanDrug: Gemcitabine

Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER

EXPERIMENTAL

Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.

Drug: AZD0901

Interventions

AZD0901DRUG

Antibody-drug conjugate/Biologic

Also known as: CMG901

Sub Study 1 - AZD0901 MONOTHERAPYSub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMASub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER

LeucovorinDRUG

Chemotherapy agents

Also known as: LV