trastuzumab deruxtecan for Unresectable and/or metastatic solid tumors with HER2 activating mutations

Inclusion criteria

• {"criterion_text":"- Adults ≥18 years old. Other age restrictions may apply as per local regulations."}
• {"criterion_text":"- Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options."}
• {"criterion_text":"- Prior HER2 targeted therapy is permitted."}
• {"criterion_text":"- All patients must provide an FFPE tumor sample for retrospective central HER2 testing."}
• {"criterion_text":"- LVEF ≥50%"}
• {"criterion_text":"- ECOG 0-1"}

Exclusion criteria

• {"criterion_text":"- HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma."}
• {"criterion_text":"- HER2 mutant NSCLC."}
• {"criterion_text":"- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening"}
• {"criterion_text":"- Lung-specific intercurrent clinically significant severe illnesses."}
• {"criterion_text":"- History of active primary immunodeficiency, known HIV, active HBV or HCV infection"}
• {"criterion_text":"- Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals"}
• {"criterion_text":"- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)."}
• {"criterion_text":"- Has spinal cord compression or clinically active central nervous system metastases."}

Primary endpoints

• {"endpoint_text":"- Confirmed objective response rate by RECIST v1.1 based on independent central review (ICR).","definition_or_measurement_approach":"Assessed by RECIST v1.1 based on independent central review (ICR)."}

Secondary endpoints

• {"endpoint_text":"- 1)\tDuration of response (DoR) based on ICR assessment.","definition_or_measurement_approach":"Duration of response as assessed by independent central review (ICR)."}
• {"endpoint_text":"- 2)\tDisease control rate (DCR) based on ICR assessment.","definition_or_measurement_approach":"Disease control rate as assessed by independent central review (ICR)."}
• {"endpoint_text":"- 3)\tProgression free survival (PFS) based on ICR assessment.","definition_or_measurement_approach":"Progression-free survival as assessed by independent central review (ICR)."}
• {"endpoint_text":"- 4)\tConfirmed Objective Response Rate (ORR) based on investigator assessment.","definition_or_measurement_approach":"Confirmed ORR as assessed by site investigators."}
• {"endpoint_text":"- 5)\tOverall survival (OS).","definition_or_measurement_approach":"Overall survival measured from date of first study treatment to date of death (as per protocol)."}
• {"endpoint_text":"- 6)\tOccurrence of adverse events (AEs) and serious adverse events (SAEs).","definition_or_measurement_approach":"Safety monitoring via recording of AEs and SAEs per protocol-defined criteria."}
• {"endpoint_text":"- 7)\tPharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181.","definition_or_measurement_approach":"PK measured by serum concentrations of T-DXd, total anti-HER2 antibody and MAAA-1181."}
• {"endpoint_text":"- 8)\tThe immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd.","definition_or_measurement_approach":"Immunogenicity assessed by detection of anti-drug antibodies (ADAs) to T-DXd."}

Denmark

Earliest CTIS Part Ii Submission Date

05-07-2024

Latest Decision Or Authorization Date

25-07-2024

Processing Time Days

20

Number Of Sites

1

Number Of Participants

1

France

Earliest CTIS Part Ii Submission Date

05-07-2024

Latest Decision Or Authorization Date

19-08-2024

Processing Time Days

45

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

sponsorDuties codes: 1,11,12,5,8

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,11,12,5,8","organisation_type":"Pharmaceutical company"}