Authorised Phase I and Phase II (Integrated)- Other Gastric Cancer, Gastroesophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer

A study of AZD0901 alone or in combination with other anticancer drugs in patients with advanced/metastatic cancer.

EU CTIS ID: 2023-508275-37-00

What this study is testing

To investigate the safety and tolerability of AZD0901 monotherapy or in combination with anti-cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2. To evaluate the preliminary anti-tumour activity of AZD0901 monotherapy or in combination with anti-cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2 in terms of ORR.

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

both sub studies: Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
Sub study 3: 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.
Sub study 1: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
Sub study 1: Advanced or metastatic GC/GEJC.
Sub study 1: The first approximately 30 participants in each arm are required to provide and archival sample up to 24 months old or a fresh tumour biopsy at screening. For participants enrolled after the first 30 in each arm, a fresh baseline biopsy is mandatory at screening, and on treatment biopsy is mandatory unless it is not clinically feasible.
Sub study 1: Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease, including CLDN18.2 targeting mAbs (other prior CLDN18.2 targeting modalities are not allowed. Prior MMAE ADC are also not allowed). (a) Progression within 6 months/183 days of last dose of prior adjuvant or neoadjuvant therapy (including herceptin, immunotherapy) is considered as equivalent to progression on one regimen for advanced or metastatic disease. (b) If one of the components of prior combination therapy is discontinued due to AE and the other continued, this is considered to be ‘one prior regimen’. (c) If the prior therapy is discontinued due to poor tolerability or AE and the patient is switched to another therapy with no documented progression, this is considered to be ‘one prior regimen’. (d) Change in dose or route of administration (eg, IV or oral fluoropyrimidine) of prior regimen without progression is considered to be ‘one prior regimen’.

You likely can't join if

both 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.
Sub study 1: Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age.
Sub study 1: The use of concomitant medications known to prolong the QT/QTc interval (refer to Section 6.9 for list of prohibited medications).
Sub study 2: Exclusion criterion 1 is specific for Arms 1, 1A, 1B and 1C (5FU specific). Exclusion criteria 2, 3, and 4 are specific for Arm 1 and Arm 1B (Irinotecan specific).
Sub study 2: Known DPD enzyme deficiency based on local testing where testing is SoC.
Sub study 2: Use of strong inhibitor or inducer of UGT1A1.

See the full eligibility criteria

Who can join

both sub studies: Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
Sub study 3: 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.
Sub study 1: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
Sub study 1: Advanced or metastatic GC/GEJC.
Sub study 1: The first approximately 30 participants in each arm are required to provide and archival sample up to 24 months old or a fresh tumour biopsy at screening. For participants enrolled after the first 30 in each arm, a fresh baseline biopsy is mandatory at screening, and on treatment biopsy is mandatory unless it is not clinically feasible.
Sub study 1: Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease, including CLDN18.2 targeting mAbs (other prior CLDN18.2 targeting modalities are not allowed. Prior MMAE ADC are also not allowed). (a) Progression within 6 months/183 days of last dose of prior adjuvant or neoadjuvant therapy (including herceptin, immunotherapy) is considered as equivalent to progression on one regimen for advanced or metastatic disease. (b) If one of the components of prior combination therapy is discontinued due to AE and the other continued, this is considered to be ‘one prior regimen’. (c) If the prior therapy is discontinued due to poor tolerability or AE and the patient is switched to another therapy with no documented progression, this is considered to be ‘one prior regimen’. (d) Change in dose or route of administration (eg, IV or oral fluoropyrimidine) of prior regimen without progression is considered to be ‘one prior regimen’.
Sub study 2: Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
Sub study 2: Availability of an archival sample up to 24 months old or a fresh tumour biopsy taken at screening.
Sub study 2: No prior treatments for unresectable or metastatic disease. Participants must not have received systemic therapy for mPDAC. Prior neoadjuvant/adjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months from the last dose.
both sub studies: Participant with previously confirmed positive CLDN18.2 test result using the same assay in other AstraZeneca studies are eligible without prospective CLDN18.2 test at pre-screening.
both sub studies: Participants who are CLDN18.2 positive. For participants who have received prior CLDN18.2 targeting therapies a new biopsy after treatment discontinuation must be provided to determine CLDN18.2 expression.
both sub studies: Must have at least one measurable lesion according to RECIST v.1.1.
both sub studies: ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior to first day of dosing.
both sub studies: life expectancy of ≥ 12 weeks.
both sub studies: Adequate organ and bone marrow function as defined by protocol.
both sub studies: Body weight > 35 kg.
both sub studies: Participants are willing to comply with contraception requirements.
Sub study 3: Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (Ampullary cancers are not eligible).

What rules you out

both 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.
Sub study 1: Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age.
Sub study 1: The use of concomitant medications known to prolong the QT/QTc interval (refer to Section 6.9 for list of prohibited medications).
Sub study 2: Exclusion criterion 1 is specific for Arms 1, 1A, 1B and 1C (5FU specific). Exclusion criteria 2, 3, and 4 are specific for Arm 1 and Arm 1B (Irinotecan specific).
Sub study 2: Known DPD enzyme deficiency based on local testing where testing is SoC.
Sub study 2: Use of strong inhibitor or inducer of UGT1A1.
Sub study 2: Use of strong inhibitors or inducers of CYP3A4. Strong inducers of CYP3A4 should be stopped at least 2 weeks before and strong inhibitors of CYP3A4 should be stopped at least 1 week before the first dose of Irinotecan.
Sub study 2: Known homozygous for the UGT1A1*28 allele based on local testing where testing is SoC.
both sub studies: Participants with clinically significant ascites that require regular drainage.
Sub study 1: Participants randomised to treatment in study D9802C00001 (CLARITY-Gastric01).
both sub studies: Participants with reported weight loss >10% within one month from the most recent weight collection at screening
both sub studies: A history of drug-induced non-infectious ILD/pneumonitis. Participants with a history of radiation pneumonitis may be eligible. Investigator must discuss each case with the AstraZeneca Study Physician prior to enrolment.
both sub studies: Central nervous system metastases or CNS pathology. The following are exceptions to this criterion: (a) Participants with history of seizures are permitted if no active seizures in last 5 years. (b) Participants with brain metastases treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to the first dose of AZD0901.
both sub studies: Peripheral neuropathy, sensory, or motor, ≥ Grade 2 at screening
both sub studies: History of another primary malignancy except for: (a) Malignancy treated with curative intent with no known active disease for at least ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. (c) Adequately treated carcinoma in situ without evidence of disease. (d) Localised non-invasive primary disease under surveillance.
both sub studies: Prior exposure to any MMAE-based ADC.
both sub studies: Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody (eg. zolbetuximab).
Sub study 1: Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
Sub study 3: Clinically significant biliary obstruction that has not resolved before enrolment

The study team makes the final eligibility decision.

Where it's taking place

Moldova, Republic of
Canada
Japan
United States
Malaysia
Taiwan
United Kingdom
Australia
Korea, Republic of
Singapore
Georgia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Moldova, Republic of; Canada; Japan; United States; Malaysia; Taiwan and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.