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Advanced Solid TumorPhase 1NCT06211647

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

A Phase 1 study testing [177Lu]Lu-XT117 in people with Advanced Solid Tumor, run by Ruimin Wang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
[177Lu]Lu-XT117
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Jan 2024to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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 of standard treatment
  • Positive FAP expression confirmed by FAP PET/CT
  • Sufficient bone marrow capacity and organ function

Who cannot join

  • High intensity and large amounts of off-target uptake detected 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 hypotensors are acceptable 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 first administration
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ang Yin contact

(+86)010-52805808

ang.yin@sinotau.com

China1 site, 1 recruiting

  • The First Medical Center, Chinese PLA General Hospital

    Beijing

    Ang Yin, (+86)010-52805808, ang.yin@sinotau.com

    Recruiting

Other trials in China

About this study

Official title: 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. Dose escalation will be conducted to determine the Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D), and to assess dosimetry characteristics.

Being tested
[177Lu]Lu-XT117

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [177Lu]Lu-XT117Drug

    [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 fixed dose levels at an interval of 6 weeks between each dose.

Study groups in NCT06211647
Study groupRoleWhat they receive
[177Lu]Lu-XT117 dose escalationExperimentalNot described
Receives: Drug: [177Lu]Lu-XT117

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment emergent adverse events

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

    Measured: Until 6 months after the last administration

  2. Dose-limiting toxicities (DLTs) during the DLT evaluation period

    A DLT is defined as any drug-related toxicity that fulfills certain criteria predescribed in the study protocol.

    Measured: Up to 6 weeks after the first administration

  3. Maximum tolerated dose (MTD)

    MTD will be determined by 3+3 dose escalation design.

    Measured: Up to 6 weeks after the first administration

  4. Recommended Phase 2 Dose (RP2D)

    RP2D will be determined on the basis of data indicating adequate tolerability and therapeutic effectiveness, and appropriate dosimestry. RP2D may be at or below the MTD.

    Measured: Through study completion, assessed up to 2 years

Secondary outcomes (6)

  1. 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.

    Measured: Every 6 weeks after first administration until disease progression or through study completion, assessed up to 2 years

  2. 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.

    Measured: Every 6 weeks after first administration until disease progression or death or through study completion, assessed up to 2 years

  3. 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

    Measured: Every 6 weeks after first administration until disease progression or 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).

    Measured: Every 6 weeks after first administration until disease progression or death or through study completion, assessed up to 2 years

  5. 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.

    Measured: Every 6 weeks after first administration until death, assessed up to 2 years

  6. 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.

    Measured: 1、4、24、48、72 and 168 hours after first administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study startJan 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211647
Sponsor's protocol ID
XT-XTR017-1-01 V1.1
Status last verified
Jan 2024
First submitted
20 Dec 2023
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu H, Guo R, Zhang X, Ji H, Sun S, Sun S, Liu J, Yang Z, Wang R. Safety and efficacy of 177Lu-FAPI-XT radioligand therapy in patients with advanced sarcoma and other cancer entities: first-in-human, dose-escalation study. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1869-1880. doi: 10.1007/s00259-025-07617-0. Epub 2025 Oct 15.

    PubMed 41087606

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [177Lu]Lu-XT117 in people with Advanced Solid Tumor, run by Ruimin Wang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ang Yin ((+86)010-52805808, ang.yin@sinotau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment emergent adverse events (time frame: Until 6 months after the last administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06211647, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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