A Phase 2/3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients with Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

Condition studied

Colorectal, Gastric, Ovarian or Pancreatic Cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Phase 2 Efficacy Endpoints: Co-Primary Endpoints: • Per-region sensitivity of GEH300079 (68Ga) PET/CT imaging to detect PC, superior to a pre-specified threshold of 75% and • Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC, superior to a pre-specified threshold of 70%, Phase 2 Exploratory Endpoints: • SUVmean and SUVmax thresholds that best discriminate Positive and Negative PC lesions • Detection of primary lesions per participant by GEH300079 (68Ga) PET/CT as compared to baseline SoC imaging, based on on-site read, Phase 2 Exploratory Endpoints: • Number of organs/anatomic structures with potential extra-PC metastases (including involvement in viscera, bones, lymph nodes) identified on GEH300079 (68Ga) PET/CT and baseline SoC imaging per participant, and percentage of participants with at least 1 organ/anatomic structure with potential extra-PC metastases identified by GEH300079 (68Ga) PET/CT scan as compared to baseline SoC imaging, based on on-site read, Phase 2 Safety Endpoints: Adverse events: • Incidence of treatment-emergent AEs (TEAEs) by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term (PT) Urinalysis and clinical laboratory parameters: • Observed values and changes from baseline • Occurrence of changes from baseline values of >40% and >80% of the span of the normal limits • Occurrence of post-administration values outside the normal limits, Phase 2 Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Observed values and changes from baseline • Occurrence of changes from baseline greater than a pre-specified magnitude (20 mmHg for systolic BP, 10 mmHg for diastolic BP, 10 beats per minute for HR, 10 breaths per minute for RR, 1.5°C for body temperature) • Occurrence of post-administration values outside the normal limits, Phase 2 Safety Endpoints: Electrocardiography: • Observed values and changes from baseline • Occurrence of changes from baseline within the following pre-specified increments: • Increments of 4 ms (<4, ≥4 to ≤8, >8 to ≤12, and >12 ms), 10 ms (<10, ≥10 to ≤20, and >20 ms) and 25 ms (<25, ≥25 to ≤50, and >50 ms) for PR interval • <30 ms, ≥30 to ≤60 ms, and >60 ms increments for QTcF interval, Phase 2 Safety Endpoints: Electrocardiography: • <50 ms, ≥50 to ≤100 ms, and >100 ms increments for QRS interval • <250 ms, ≥250 to ≤500 ms, and >500 ms increments for RR interval • Occurrence of post-administration values outside the normal limits in the PR, QTc, QRS or RR interval • Overall interpretation at each post-administration time point Physical examination: • Occurrence of changes from baseline in physical examination status (normal/abnormal), Phase 3: Efficacy Endpoints: • Per-region sensitivity of GEH300079 (68Ga) PET/CT imaging for the detection of PC, superior to a prespecified threshold of 75% and • Per-region specificity of GEH300079 (68Ga) PET/CT imaging for the detection of PC, superior to a prespecified threshold of 70%, Phase 3: Exploratory Endpoints: • SUVmean and SUVmax thresholds that best discriminate Positive and Negative PC lesions • Detection of primary lesions per participant by GEH300079 (68Ga) PET/CT as compared to baseline SoC imaging, based on on-site read, Phase 3: Exploratory Endpoints: • Number of organs/anatomic structures with potential extra-PC metastases (including involvement in viscera, bones, lymph nodes) identified on GEH300079 (68Ga) PET/CT and baseline SoC imaging per participant, and percentage of participants with at least 1 organ/anatomic structure with potential extra-PC metastases identified by GEH300079 (68Ga) PET/CT scan as compared to baseline SoC imaging, based on on-site read, Phase 3: Safety Endpoints: AEs: • Incidence of TEAEs by MedDRA system organ class and PT Urinalysis and clinical laboratory parameters: • Observed values and changes from baseline • Occurrence of changes from baseline values of >40% and >80% of the span of the normal limits • Occurrence of post-administration values outside the normal limits, Phase 3: Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Observed values and changes from baseline • Occurrence of changes from baseline greater than a pre-specified magnitude (20 mmHg for systolic BP, 10 mmHg for diastolic BP, 10 beats per minute for HR, 10 breaths per minute for RR, 1.5°C for body temperature), Phase 3: Safety Endpoints: Vital signs (BP, RR, HR, body temperature): • Occurrence of post-administration values outside the normal limits Physical examination: • Occurrence of changes from baseline in physical examination status (normal/abnormal)

Endpoint detail

Phase 2: Efficacy Endpoints: Co-key Secondary Endpoints: I. Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging (i.e., CT, MR, or [18F]FDG PET/CT) and II. Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging, Phase 3: Efficacy Endpoints: Co-Key Secondary Endpoints: I. Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging (i.e., CT, MR or [18F]FDG PET/CT) and II. Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging