AZD0901 in participants with advanced solid tumours expressing Claudin18.2

Study identifier:D9800C00001

ClinicalTrials.gov identifier:NCT06219941

EudraCT identifier:N/A

CTIS identifier:2023-508275-37-00

Recruiting

Official Title

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)

Medical condition

gastric cancer

Phase

Phase 2

Healthy volunteers

Study drug

AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan, Nanoliposomal Irinotecan, Gemcitabine

Sex

All

Estimated Enrollment

190

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 13 Dec 2023

Estimated Primary Completion Date: 30 Dec 2025

Estimated Study Completion Date: 31 Dec 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

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Arms	Assigned Interventions
Experimental: Sub Study 1 - AZD0901 MONOTHERAPY Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.	Drug: AZD0901 Antibody-drug conjugate/Biologic Other Name: CMG901
Experimental: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents	Drug: AZD0901 Antibody-drug conjugate/Biologic Other Name: CMG901 Drug: 5-Fluorouracil Chemotherapy agents Other Name: 5-FU Drug: Leucovorin Chemotherapy agents Other Name: LV Drug: l-leucovorin Chemotherapy agents Other Name: I-LV Drug: Irinotecan Chemotherapy agents Other Name: Camptosar Drug: Nanoliposomal Irinotecan Chemotherapy agents Other Name: ONIVYDE Drug: Gemcitabine Chemotherapy agents Other Name: Gemzar
Experimental: Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.	Drug: AZD0901 Antibody-drug conjugate/Biologic Other Name: CMG901

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]