A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors

A Clinical Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Efficacy of [177Lu]Lu-XT117 Injection in FAP-positive Patients With Advanced Solid Tumors

This is a single-center, single-arm clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-XT117 injection in patients with FAP-positive advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: [177Lu]Lu-XT117

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ruiyue Zhao; Phone Number: (+86)18811477055; Email: zhaory2014@163.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • The First Affiliated Hospital of Guangzhou Medical University
    • Contact: Ruiyue Zhao; Phone Number: (+86)18811477055; Email: zhaory2014@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• ≥18 years old
• Eastern Cooperative Oncology Group (ECOG) Performance status 0 to 1
• Confirmed as malignant solid tumor by histopathology
• Have measurable lesions based on RECIST 1.1
• Have failed standard treatment (disease progression or intolerance) or lack standard treatment
• Positive FAP expression confirmed by FAP PET/CT
• Sufficient bone marrow capacity and organ function

Key Exclusion Criteria:

• High intensity and large amounts of off-target uptake by FAP molecular imaging, and were assessed as inappropriate for [177Lu]Lu-XT117 therapy by the investigators
• Previous systemic antitumor therapy (including prior chemotherapy, radiotherapy, immunotherapy, and other investigational drugs) ≤28 days before receiving study therapy; previous treatment with Chinese medicine with anti-tumor indications within 2 weeks before receiving study therapy
• Uncontrolled diabetes, with baseline fasting blood glucose > 2×ULN
• Clinically significant serious cardiovascular disease, including but not limited to: a. >Grade II congestive heart failure as per New York Heart Association (NYHA) ; b. Unstable angina pectoris or myocardial infarction within 6 months before the first administration of the study drug; c. Severe arrhythmia within 6 months prior to the first administration; d. Poorly controlled hypertension (patients who keep the blood pressure to ≤ Grade 2 hypertension [CTCAE5.0] with hypotensor are allowed for enrollment); e. QTc>450 ms (male) or 470 ms (female), congenital prolonged QT syndrome, and use of medications that prolong QT
• Clinically serious thromboembolic disease within 6 months prior to the first administration of the study drug
• Major surgery within 4 weeks prior to the initial administration of the study drug
• History of severe gastrointestinal ulcers or perforations or history of intestinal obstruction within 6 months prior to the first administration
• Active infection requiring systemic treatment (oral or intravenous administration) within 2 weeks prior to the first administration, except for topical treatment
• History of non-infectious interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis, idiopathic interstitial pneumonia, pneumoconiosis, and drug-related interstitial pneumonia, or severe impairment of lung function
• Had other malignancies within 5 years prior to screening (except clinically cured early stage malignancies)

• Primary central nervous system (CNS) tumor or symptomatic CNS metastasis, expect:

  • Subjects with asymptomatic brain metastases;
  • Subjects whose CNS lesions were stable for ≥4 weeks after local treatment and who stopped glucocorticoid or anticonvulsant therapy at least 2 weeks prior to study drug administration could be enrolled;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [177Lu]Lu-XT117 treatment	Drug: [177Lu]Lu-XT117; [177Lu]Lu-XT117 is a radiopharmaceutical therapy in which an beta emitter, Lu-177, is conjugated to XT117. Patients will receive [177Lu]Lu-XT117 administration at an interval of 6 weeks between each dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment emergent adverse events	Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.	Until 6 months after the last administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as the proportion of participants with best overall response of Complete Response (CR) or Partial Response (PR) as measured by RECIST v1.1.	Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years
Duration of Response (DOR)	DOR is the time from the date of the first documented response (CR or PR) to the date of the first radiologically documented disease progression or death due to disease according to RECIST v1.1.	Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years
Disease Control Rate (DCR)	DCR is the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1	Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years
Progression Free Survival (PFS)	PFS is defined as the interval from the date of first dosing to the date of first demonstrated disease progression, or to the last date of known progression-free condition of the patient, or to the date of death (based on RECIST 1.1).	Every 6 weeks after first administration until disease progression or death or through study completion, assessed up to 2 years
Overall Survival (OS)	OS is defined as the interval from the date of first dosing to the date of death for any cause, or to the last date of known survival.	Every 6 weeks after first administration until death, assessed up to 2 years
Radiation dosimetry of [177Lu]Lu-XT117 to whole body, lesions, organs, and selected regions of interest	Radiation dosimetry is assessed by SPECT/CT and/or planar images.	1、4、24、48、72 and 168 hours after first administration

Collaborators and Investigators

• Sponsor: Xinlu Wang
• Collaborators: Sinotau Pharmaceutical Group

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: XT-XTR017-1-01 V1.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No