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AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

PHASE2RECRUITING

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.

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Study details:

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 activity of AZD0901 monotherapy in participants with advanced or metastatic gastric esophageal cancer expressing CLDN18. 2.

Participants will receive AZD0901 monotherapy via intravenous (IV) infusion and will be randomised in to one of 2 arms. Sub study 2 will consist of two parts, a safety run-in and a dose expansion part to investigate the safety and efficacy of AZD0901 in combination with different chemotherapy agents in participants with pancreatic cancer.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

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.

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.

Exclusion criteria

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 ≥ 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.

Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.

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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-12-13

Primary completion: 2025-05-02

Study completion finish: 2027-01-19

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT06219941

Intervention or treatment

DRUG: AZD0901

DRUG: 5-Fluorouracil

DRUG: Leucovorin

DRUG: l-leucovorin

DRUG: Irinotecan

DRUG: Nanoliposomal Irinotecan

DRUG: Gemcitabine

Conditions

• Gastric Cancer
• Gastroesophageal Junction Cancer
• Pancreatic Adenocarcinoma

Condition: Gastric Cancer, Gastroesophageal Junction Cancer and more
DRUG: AZD0901 and other drugs
Melbourne, Not Specified, Australia and more
Sponsor: AstraZeneca

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Find a site

Closest Location:

Research Site

Research sites nearby

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Research Site
Melbourne, Not Specified, Australia
Research Site
Randwick, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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
EXPERIMENTAL: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS 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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Overall Survival (OS)	The analysis will include all dosed/randomised participants as assigned/randomised. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.	From date of first dose/randomisation until the date of death due to any cause (approximately 2 years).
Progression Free Survival (PFS)	Progression-free survival is defined as the time date of randomisation or enrollment until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause, regardless of whether the participant withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression.	From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 2 years).
Duration of Response (DoR)	The time from the date of first documented confirmed response until date of first documented progression per RECIST v1.1 or death due to any cause.	From the date of first documented confirmed response until date of documented progression (approximately 2 years).
Disease control rate (DCR)	The percentage of participants who have a confirmed CR or PR or who have SD per RECIST v1.1 as assessed by the Investigator at local site and derived from the raw tumour data for at least 11 weeks after date of first dose/randomisation.	From start until 12 weeks.
Percentage change in tumor size	The best percentage change from baseline in tumor size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST v1.1 assessments.	From start through to study completion.
Serum concentration of AZD0901 (total ADC), total antibody (conjugated and unconjugated) and total unconjugated MMAE	To characterise the PK of AZD0901 monotherapy or in combination with anti cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.	From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.
Serum PK parameters of AZD0901, total antibody (conjugated and unconjugated) and MMAE including but not limited to AUC, Cmax, tmax, clearance and half-life, as data allow.	To characterise the PK of AZD0901 monotherapy or in combination with anti cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.	From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.
Clinical activity by baseline and/or on-treatment tissue-based biomarkers including, but not limited to, gene expression, mutation profiles, DNA damage, protein expression, immune response and/or mechanisms of resistance.	To investigate baseline and/or on-treatment tissue-based RNA, DNA, and/or proteins, and association with clinical activity of AZD0901 (substudy 1).	From date of first dose of AZD0901 up to 7 weeks.
ADA status will be determined along with prevalence and incidence of anti-drug antibodies to AZD0901, and titer established.	To determine the immunogenicity of AZD0901 monotherapy or in combination with anti-cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.	From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

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References

Clinical Trials Gov: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2