A Phase 2 diagnostic study with 68Ga-EVG321 in Patients with Small Cell Lung Cancer
Key facts
- Where
- Innsbruck, AusztriaSee the site
- Phase
- 2. fázis
Where in Ausztria
- Medizinische Universitaet InnsbruckInnsbruck, AusztriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Evergreen Theragnostics Inc.
- Trial code
- EU 2024-514584-25-00
- Record updated
- 2026. szeptember 3.
- Original description
To assess the whole-body distribution and dosimetry of 68Ga-EVG321 in participants with histologically confirmed SCLCRead full original descriptionShow less
To assess the whole-body distribution and dosimetry of 68Ga-EVG321 in participants with histologically confirmed SCLC
Inclusion: Signed and dated ICF prior to any study-mandated procedure; Male or female participants aged 18 years old and above at the time of signing the ICF; ECOG performance status 0, 1 or 2; Participants with histologically or cytologically confirmed small cell lung cancer (SCLC); Participants with evaluable ex-vivo tumour tissue; Women of childbearing potential (WOCBP) defined as all women physiologically capable of becoming pregnant, must have a documented negative urine/serum pregnancy test. WOCBP who are sexually active, must agree to use highly effective means of contraception (as per CTFG criteria, refer to Appendix A of protocol) during the study period and for at least 7 months after study drug discontinuation; Sexually active male participants must agree to use condoms throughout the study period and for 4 months after study drug discontinuation if their female partner is of child-bearing potential and is using no highly effective methods of contraception, or have documented sterilization by vasectomy. In addition, male participants agree not to donate semen during the same period.
Exclusion: Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical; Organ allograft requiring immunosuppressive therapy; Known hypersensitivity to gallium-68, EVG321 or to any of the excipients of the IMP; Any condition that precludes raised arms position for prolonged imaging purposes; Clinically abnormal ECG (signs of ischemia, high grade ventricular arrhythmia, high grade supra-ventricular arrhythmia); 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: • Hematologic (Platelets <75K/mcL; ANC <1.0 K/mcL) • Hepatic (Bilirubin >2.0 x ULN; AST/ALT >2.5 x ULN) • Renal (eGFR or creatinine clearance <30 mL); Marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval calculated with Fridericia's correction (QTcF > 470 msec for both males and females); History of clinical risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); Other known co-existing malignancies with clinical relevance except participants with a history of malignant tumors in complete remission >3 years, with no evidence of recurrence <5 years; Persons with any kind of relationship with the investigator or employed by the sponsor or investigator; Persons held in an institution by legal or official order; Claustrophobia interfering with PET/CT imaging; Pregnancy, breast-feeding; Participants with bladder outflow obstruction or unmanageable urinary incontinence.