A Clinical Study of [225Ac]Ac-FAPI-XT(XT117) Injection in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiaorong Sun

About this trial

This is a single-center, single-arm clinical study to evaluate the safety, tolerability and preliminary efficacy of \[225Ac\]Ac-FAPI-XT injection in patients with FAP-positive advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

High intensity and large amounts of off-target uptake by FAP molecular imaging 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)

Trial design

Design model

Sequential

Treatments tested in this trial

  • 225Ac-FAPI-XT

    Drug

    Patients will receive \[225Ac\]Ac-FAPI-XT(XT117) administration at an interval of 6 weeks between each dose.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: 225Ac-FAPI-XT treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment emergent adverse events

adverse events Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.

Time frame
Through study completion, assessed up to 2 years
2

Dose-limiting toxicity(DLT)

Incidence and severity of dose-limiting toxicities.

Time frame
Through study completion, assessed up to 2 years

Secondary outcomes

1

Overall Response Rate (ORR)

Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline.(based on RECIST 1.1).

Time frame
Through study completion, assessed up to 2 years.
2

Duration of Response (DOR)

Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause .(based on RECIST 1.1).

Time frame
Through study completion, assessed up to 2 years.
3

Disease Control Rate (DCR)

Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1.

Time frame
Through study completion, assessed up to 2 years
4

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).

Time frame
Through study completion, assessed up to 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiaorong Sun

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution