Clinical Trial · NCT06081322

A Study to Evaluate the Safety and Efficacy of PRRT With 177Lu-EB-FAPI in Patients With Advanced Cholopancreatic Tumors

Overview

This study is a prospective, single-center, open, single-arm, exploratory study to evaluate the safety and efficacy of 177Lu-EB-FAPI PRRT, and to explore 177Lu-EB-FAPI in patients with advanced pancreatic cancer and cholangiocarcinoma. Eligible patients with advanced pancreatic cancer or cholangiocarcinoma were screened and enrolled after signing the informed consent forms. In the first stage of the enrolled patients, the 177Lu-EB-FAPI treatment dose was determined using a 3 + 3 dose escalation mode. Patients enrolled in the second phase, divided into pancreatic cancer cohort and cholangiocarcinoma based on pathology, will receive the first phase determined dose of 177Lu-EB-FAPI every 4 weeks, and each patient will receive no more than 4 cycles. The aim of the study is to evaluate the safety and efficacy of the 177Lu-EB-FAPI treatment.

Sponsor

Zhejiang University

Phase

Phase 1

Contacts

Tingbo Liang, PhD (CONTACT)

liangtingbo@zju.edu.cn

+86 19941463683

Yiwen Chen, MD (CONTACT)

cherry0705@zju.edu.cn

+86 15088682641

ClinicalTrials.gov

NCT06081322

Drug / Compound

EB-FAPI

Isotope(s):

Target(s):

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Phase Ia requires patients who have previously failed at least 2 lines of systemic chemotherapy or who the investigator considers unsuitable to receive systemic chemotherapy; Phase Ib Cohort 1, enrollment of patients with hist-or cytologically confirmed metastatic pancreatic cancer; Phase Ib Cohort 2, enrollment of patients with hist-or cytologically confirmed metastatic cholangiocarcinoma;
Patients must have reliable contraception during the study and within 6 months after the study period; negative serum pregnancy / urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects; male subjects should agree to have contraception during the study and within 6 months after the end of the study period.
Phase Ia requires at least one evaluable lesion confirmed per RECIST 1.1 criteria; Phase Ib requires at least one measurable lesion confirmed per RECIST 1.1 criteria;
Received 68 Ga-FAPI 46 PET imaging positive before treatment;
Major organs function well;
ECOG score 0-1, expected survival greater than 3 months;

Exclusion

Motor / venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months before the first medication;
Patients with a history of psychiatric substance abuse and unable to quit or with mental disorders;
Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;
According to the discretion of the investigator, subjects with a serious hazard to subject safety or concomitant illness affecting the study or other reasons for enrollment.
Symptomatic interstitial lung disease, and conditions that may cause drug pulmonary toxicity or associated pneumonia;
Long-term non-healed wound or fracture; Active bleeding or high risk of bleeding considered by the investigator, such as gastric fundus varices, hemoptysis, etc.;
Major surgical treatment with significant traumatic injury within 28 days prior to the first medication;
Prior treatment before the first dose included chemotherapy and targeted therapy with any associated toxicity (CTCAE v5.0) of\> 1 N. A., excluding alopecia;
Patients with any severe and / or uncontrolled disease.
Claustrophobic or radiologically phobic patients, or patients with mental disorders or primary affective disorders;
Previous history of severe allergy to macromolecular drugs, or allergy to the known component of 177Lu-EB-FAPI injection;