68Ga-FAPI-46 PET-CT for molecular assessment of fibroblast activation and risk assessment in solid tumors (FAPI Basket)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

1 May 2023 → ongoing

Decision date (initial)

2024-06-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511659-17-00

EudraCT number

2022-003786-38

ClinicalTrials.gov

NCT06136065

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety

To evaluate the sensitivity of 68Ga-FAPI-46 PET/CT in patients with solid tumors and with 18F-FDG PET scan or other clinical practice morpho-functional imaging dubious or inconclusive.

Secondary objectives 4

1. To evaluate 68Ga-FAPI-46 PET/CT sensitivity by tumor histotype
2. To evaluate 68Ga-FAPI-46 PET/CT sensitivity by lesion site
3. To describe 68Ga-FAPI-46 uptake
4. To evaluate safety

Conditions and MedDRA coding

Solid tumors

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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
2. 18F-FDG PET/CT scan or other clinical practice morpho-functional imaging dubious or inconclusive.
3. Male or Female, aged≥18 years
4. ECOG performance status ≤2
5. 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.
6. Participant is willing and able to give informed consent for participation in the study

Exclusion criteria 10

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 4

1. 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
2. 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;
3. 68Ga-FAPI-46 uptake in terms of SUV
4. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Via Piero Maroncelli 40

City

Meldola

Postcode

47014

Country

Italy

Scientific contact point

Organisation

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

Contact name

Paola Caroli

Public contact point

Organisation

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

Contact name

Oriana Nanni

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications