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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501570-18-00 | Registry Identifier | CTIS (EU) |
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This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1 AZD9592 Monotherapy | Experimental | Module 1 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 as monotherapy in select solid tumors |
|
| Module 2 AZD9592 Combination with Osimertinib | Experimental | Module 2 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with Osimertinib. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with Osimertinib in NSCLC EGFRm |
|
| Module 3 AZD9592 Combination 5-FU, Bevacizumab, Leucovorin | Experimental | Module 3 has two parts: Part A aims to determine the safety, tolerability and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC) Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9592 | Drug | Varying doses of AZD9592 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Number of patients with adverse events by system organ class and preferred term | From time of Informed Consent to 30 days post last dose of AZD9592 |
| Incidence of Serious Adverse Events (SAEs) | Number of patients with serious adverse events by system organ class and preferred term | From time of Informed Consent to 30 days post last dose of AZD9592 |
| Incidence of dose-limiting toxicities (DLT) as defined in the protocol | Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol | From time of first dose of AZD9592 to end of DLT period (approximately 21 days) |
| Incidence of baseline laboratory finding, ECG and vital signs changes | measured by laboratory and vital sign variables over time including change from baseline | From time of Informed Consent to 30 days post last dose of AZD9592 |
| Proportion of patients with radiological response (ORR) | Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only) | From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1) | From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
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Key Inclusion Criteria:
Additional Inclusion Criteria for Module 1:
• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.
Additional Inclusion Criteria for Module 2:
• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.
Additional Inclusion Criteria for Module 3:
• Histologically or cytologically confirmed metastatic CRC.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charu Aggarwal, MD, MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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| Osimertinib | Drug | tablets administered orally |
|
| 5-Fluorouracil (5-FU) | Drug | IV infusion |
|
| Leucovorin | Drug | IV infusion |
|
| Bevacizumab | Drug | IV infusion |
|
| Duration of Response (DoR) |
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression |
| From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
| Disease Control Rate (DCR) at 12 weeks | The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for >=11 weeks from first dose | From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks) |
| Progression free Survival (PFS) | The time from first dose until RECIST 1.1 defined disease progression or death due to any cause | From date of first dose of AZD9592 up until date of progression or death due to any cause (approximately 2 years) |
| Overall Survival (OS) | The time from the date of the first dose of study treatment until death due to any cause. | From date of first dose of AZD9592 up until the date of death due to any cause (approximately 2 years) |
| Pharmacokinetics of AZD9592: Plasma PK concentrations | Measurement of plasma concentrations of AZD9592, total antibody and total unconjugated warhead | From date of first dose of AZD9592 up until 30 days post last dose |
| Pharmacokinetics of AZD9592: Area under the concentration time curve (AUC) | Measurement of PK parameters: Area under the concentration time curve (AUC) | From date of first dose of AZD9592 up until 30 days post last dose |
| Pharmacokinetics of AZD9592: Maximum plasma concentration of the study drug (C-max) | Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max) | From date of first dose of AZD9592 up until 30 days post last dose |
| Pharmacokinetics of AZD9592: Time to maximum plasma concentration of the study drug (T-max) | Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max) | From date of first dose of AZD9592 up until 30 days post last dose |
| Pharmacokinetics of AZD9592: Clearance | Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance) | From date of first dose of AZD9592 up until 30 days post last dose |
| Pharmacokinetics of AZD9592: Half-life | Measurement of PK parameters: Terminal elimination half-life (t 1/2) | From date of first dose of AZD9592 up until 30 days post last dose |
| Immunogenicity of AZD9592: Anti-Drug Antibodies (ADA) | Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment | From date of first dose of AZD9592 up until 30 days post last dose |
| North Haven |
| Connecticut |
| 06473 |
| United States |
| Research Site | Washington D.C. | District of Columbia | 20016 | United States |
| Research Site | Chicago | Illinois | 60637 | United States |
| Research Site | Baltimore | Maryland | 21224 | United States |
| Research Site | Baltimore | Maryland | 21231 | United States |
| Research Site | Milford | Massachusetts | 01757 | United States |
| Research Site | Mineola | New York | 11501 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | New York | New York | 10021 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Providence | Rhode Island | 02903 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Fairfax | Virginia | 22031 | United States |
| Research Site | Kogarah | 2217 | Australia |
| Research Site | Melbourne | 3000 | Australia |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Toronto | Ontario | M5G 1X6 | Canada |
| Research Site | Beijing | 100142 | China |
| Research Site | Chongqing | 400030 | China |
| Research Site | Guangzhou | 510100 | China |
| Research Site | Wuhan | 430022 | China |
| Research Site | Marseille | 13385 | France |
| Research Site | Rennes | 35000 | France |
| Research Site | Villejuif | 94805 | France |
| Research Site | Milan | 20162 | Italy |
| Research Site | Orbassano | 10043 | Italy |
| Research Site | Rozzano | 20089 | Italy |
| Research Site | Verona | 37134 | Italy |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Kuala Lumpur | 59100 | Malaysia |
| Research Site | Kuching | 93586 | Malaysia |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Barcelona | 8035 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006258 | Head and Neck Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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