(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Solid tumors

Inclusion criteria

• {"criterion_text":"- Patients must have histologically or cytologically solid tumors at any stage, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion\n- 18F-FDG PET/CT scan or other clinical practice morpho-functional imaging dubious or inconclusive.\n- Male or Female, aged≥18 years\n- ECOG performance status ≤2\n- female participant is eligible to participate if she is not pregnant and not breastfeeding. If female of childbearing potential highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”, (See Appendix D) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing at least 6 months following last treatment with study drug. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; IRST100.59 - FAPI BASKET Page 16 of 35 Prot_v3.1_14.01.24 vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months.\n- Participant is willing and able to give informed consent for participation in the study"}

Exclusion criteria

• {"criterion_text":"- Participation in another clinical trial with any investigational agents within 30 days prior to study entry or 5 hemivitae of the study drug\n- Subject deprived of its freedom by administrative or legal decision or who is under guardianship\n- Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent\n- History of allergic reactions attributed to compounds of similar chemical or biologic composition to FAPI or other agents used in the study.\n- Inability to remain still for the entire duration of the exam\n- Life expectancy < 6 months\n- ECOG performance status > 2\n- Patient with compromised renal function (Creatinine> 2 mg/ml)\n- Patient with altered hepatic function (AST and ALT > 2.5 respect to upper normal limits)\n- Pregnancy and lactation"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the evaluation of the detection rate of 68Ga-FAPI-46 PET/CT, defined as the proportion of 68Ga-FAPI-46 positive patients and the total number of recruited patients. A positive patient is defined as a patient with at least one 68Ga-FAPI-46 positive lesion. Primary tumor, lymph nodes and metastasis will be considered positive if specific concentration of radioligand in target tissue exceeds the unspecific concentration in adjacent tissues.","definition_or_measurement_approach":"Detection rate measured as proportion of 68Ga-FAPI-46 positive patients among total recruited. A positive patient = at least one 68Ga-FAPI-46 positive lesion. Lesions (primary tumor, lymph nodes, metastasis) considered positive when radioligand concentration in target tissue exceeds unspecific concentration in adjacent tissues."}

Secondary endpoints

• {"endpoint_text":"- Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each tumor histology","definition_or_measurement_approach":"Proportion of PET/CT-positive patients per tumor histology (number positive / total scanned for that histology)."}
• {"endpoint_text":"- Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each lesion site and proportion of 68Ga-FAPI-46 PET/CT-positive lesions over the total number of lesions for each lesion site;","definition_or_measurement_approach":"Proportion of positive patients and proportion of positive lesions by lesion site (patient-level and lesion-level denominators specified)."}
• {"endpoint_text":"- 68Ga-FAPI-46 uptake in terms of SUV","definition_or_measurement_approach":"Quantitative uptake assessed by standardized uptake value (SUV) measurements."}
• {"endpoint_text":"- Safety is defined as the number and percentage of patients undergoing grade 1 to 4 adverse events according to CTCAE version 5.0 until 30 days post 68Ga-FAPI-46 PET/CT.","definition_or_measurement_approach":"Safety measured as number and % of patients with CTCAE v5.0 grade 1-4 adverse events occurring up to 30 days after PET/CT."}

Italy

Earliest CTIS Part Ii Submission Date

14-05-2024

Latest Decision Or Authorization Date

09-09-2025

Processing Time Days

483

Number Of Sites

2

Number Of Participants

200

Primary sponsor

Full Name

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy