Gallium (68Ga); EVG321 for Small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Signed and dated ICF prior to any study-mandated procedure\n- Male or female participants aged 18 years old and above at the time of signing the ICF\n- ECOG performance status 0, 1 or 2\n- Participants with histologically or cytologically confirmed small cell lung cancer (SCLC)\n- Participants with evaluable ex-vivo tumour tissue\n- Participants of childbearing potential (WOCBP) must have a negative urine/serum pregnancy test. WOCBP who are sexually active, must use a highly effective/acceptable method of contraception from Visit 1 up to at least 14 days after discontinuation of study intervention. Allowed are accepted and effective non-hormonal methods of contraception and sexual abstinence or vasectomized partners (>3 months previously). Vasectomy has to be confirmed by two negative semen analyses\n- Male participants sexually active with a partner of childbearing potential must agree to use a male condom from the day of administration of study intervention up to at least 14 days after or have documented permanent sterilization by vasectomy. They agree not to donate semen during the study period and for 14 days after study termination"}

Exclusion criteria

• {"criterion_text":"- Other known co-existing malignancies with clinical relevance except participants with a history of malignant tumors complete remission >3 years, with no evidence of recurrence <5 years\n- Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical\n- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator\n- Persons held in an institution by legal or official order\n- Organ allograft requiring immunosuppressive therapy\n- Significantly impaired organ function that may interfere with the excretion and metabolism of the imaging agent. Specifically, participants will be excluded if they meet the following criteria: •\tHematologic (Platelets <75K/mcL; ANC <1.0 K/mcL) •\tHepatic (Bilirubin >2.0 x ULN; AST/ALT >2.5 x ULN) •\tRenal (eGFR or creatinine clearance <30 mL or Creatinine > 2.0 x ULN)\n- Claustrophobia interfering with PET/CT imaging\n- Clinically abnormal ECG (signs of ischemia, high grade ventricular arrhythmia, high grade supra-ventricular arrhythmia)\n- Pregnancy, breast-feeding\n- Participants with bladder outflow obstruction or unmanageable urinary incontinence\n- Known hypersensitivity to gallium-68, EVG321 or to any of the excipients of the IMP\n- Any condition that precludes raised arms position for prolonged imaging purposes"}

Primary endpoints

• {"endpoint_text":"- Quantitative measurements of 68Ga-EVG321 radioactivity in volumes of interest (VOIs) from whole-body images over target organs will be made at several time points","definition_or_measurement_approach":"Quantitative measurements of 68Ga-EVG321 radioactivity in VOIs from whole-body images over target organs performed at several time points (image-based radioactivity quantification across timepoints)."}

Secondary endpoints

• {"endpoint_text":"- Safety and tolerability, including treatment emergent adverse events and pre/post-68Ga-EVG321 PET/CT lab values, ECGs and vital signs","definition_or_measurement_approach":"Assessment of treatment-emergent adverse events and comparison of pre- and post-68Ga-EVG321 PET/CT laboratory values, ECGs and vital signs."}
• {"endpoint_text":"- Pharmacokinetic parameters [e.g., Cmax, area under the curve (AUC), total clearance (CL), steady-state volume of distribution (Vss) and mean residence time (MRT)] of 68Ga- EVG321 in both healthy tissues and primary/metastatic lesions","definition_or_measurement_approach":"Measurement of PK parameters such as Cmax, AUC, CL, Vss and MRT for 68Ga-EVG321 in healthy tissues and lesions derived from serial imaging and/or bio-sampling as specified."}
• {"endpoint_text":"- Comparison of 68Ga-EVG321 PET/CT imaging to determine the presence of CCK2R expressing SCLC relative to histopathology","definition_or_measurement_approach":"Comparison of PET/CT imaging results to histopathology to determine presence of CCK2R-expressing SCLC (imaging vs histopathology concordance assessment)."}

Germany

Earliest CTIS Part Ii Submission Date

06-08-2024

Latest Decision Or Authorization Date

10-10-2024

Processing Time Days

65

Number Of Sites

1

Number Of Participants

7

Italy

Earliest CTIS Part Ii Submission Date

19-09-2024

Latest Decision Or Authorization Date

21-10-2024

Processing Time Days

32

Number Of Sites

1

Number Of Participants

6

Austria

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

14-10-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Evergreen Theragnostics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmtrace klinische Entwicklung GmbH

Responsibilities

codes: 10,12,5,6,7,8

Third parties

• {"country":"Germany","full_name":"Pharmtrace klinische Entwicklung GmbH","duties_or_roles":"codes: 10,12,5,6,7,8","organisation_type":"Pharmaceutical company"}