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

NCT ID: NCT06081322

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Advanced Pancreatic Cancer and Cholangiocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase Ia: Dose escalation

To determine the therapeutic dose of 177Lu-EB-FAPI using a 3 + 3 dose-escalation mode

Group Type: EXPERIMENTAL

PRRT with 177Lu-EB-FAPI

Intervention Type: DRUG

PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue

Phase Ib: Dose expansion-pancreatic cancer cohort

In pancreatic cancer cohort, patients will receive the first phase determined dose of 177Lu-EB-FAPI every 4 weeks, and each patient will receive no more than 4 cycles.

Group Type: EXPERIMENTAL

PRRT with 177Lu-EB-FAPI

Intervention Type: DRUG

PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue

Phase Ib: Dose expansion-cholangiocarcinoma cohort

In cholangiocarcinoma cohort, patients will receive the first phase determined dose of 177Lu-EB-FAPI every 4 weeks, and each patient will receive no more than 4 cycles.

Group Type: EXPERIMENTAL

PRRT with 177Lu-EB-FAPI

Intervention Type: DRUG

PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue

Interventions

PRRT with 177Lu-EB-FAPI

PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed the informed consent form;

2. Age: 18-75 years old (when signing the informed consent form);

3. Received 68 Ga-FAPI 46 PET imaging positive before treatment;

4. 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;

5. 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;

6. ECOG score 0-1, expected survival greater than 3 months;

7. Major organs function well;

8. 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.

Exclusion Criteria

1. Prior treatment before the first dose included chemotherapy and targeted therapy with any associated toxicity (CTCAE v5.0) of> 1 N. A., excluding alopecia;

2. Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;

3. Within 5 years, the patient had previous or both other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); had other malignant tumors, but the following two conditions can be enrolled: other malignant tumors treated with single surgery with R0 resection and no recurrence and metastasis; cured cervical carcinoma in situ, skin basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];

4. Major surgical treatment with significant traumatic injury within 28 days prior to the first medication;

5. 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.;

6. 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;

7. Patients with a history of psychiatric substance abuse and unable to quit or with mental disorders;

8. Symptomatic interstitial lung disease, and conditions that may cause drug pulmonary toxicity or associated pneumonia;

9. Patients with any severe and / or uncontrolled disease.

10. Previous history of severe allergy to macromolecular drugs, or allergy to the known component of 177Lu-EB-FAPI injection;

11. Claustrophobic or radiologically phobic patients, or patients with mental disorders or primary affective disorders;

12. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

TingBo Liang

The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tingbo Liang, PhD

Role: CONTACT

liangtingbo@zju.edu.cn

+86 19941463683

Yiwen Chen, MD

Role: CONTACT

cherry0705@zju.edu.cn

+86 15088682641

Facility Contacts

Yiwen Chen, MD

Role: primary

19941463683

Other Identifiers

CISPD-5

Identifier Type: -

Identifier Source: org_study_id