Exploratory Clinical Study of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors

NCT07587996 | Completed Early Phase 1

• 1 other identifier: 2024A-1337
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, non-randomized, single-arm, open-label exploratory clinical study of ¹⁷⁷Lu-CTR-FAPI in patients with FAP-high expressing metastatic solid tumors, with a focus on breast cancer, sarcoma, and thyroid cancer. The purpose of this study is to evaluate the safety and tolerability of ¹⁷⁷Lu-CTR-FAPI. The study will also assess its in vivo biodistribution, radiation absorbed dose in normal organs and target lesions, and preliminary clinical efficacy. The main question this study aims to answer is whether ¹⁷⁷Lu-CTR-FAPI can be administered safely and shows sufficient tumor-targeting and preliminary therapeutic activity to support further clinical investigation in patients with FAP-high expressing metastatic solid tumors.

Conditions

Metastatic Solid Tumors (Any Localization)

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-Emergent Adverse Events

  Number of participants with treatment-emergent adverse events, serious adverse events, and adverse events leading to treatment discontinuation. Adverse events will be coded and graded according to the Common Terminology Criteria for Adverse Events version 5.0.

  From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration

• Number of Participants With Abnormal Vital Signs

  Number of participants with clinically significant abnormal vital signs, including systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation, as determined by the investigator.

  From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration

• Number of Participants With Abnormal Laboratory Test Results

  Number of participants with clinically significant abnormal laboratory test results, including complete blood count, liver function tests, renal function tests, and serum electrolytes, graded according to the Common Terminology Criteria for Adverse Events version 5.0 when applicable.

  From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration

Secondary Outcomes (3)

• Objective Response Rate

  Every 8 weeks from baseline until disease progression, initiation of new anticancer therapy, withdrawal, death, or study completion, up to 12 months

• Progression-Free Survival

  From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI until disease progression or death, up to 12 months

• Radiation dosimetry

  It should be measured within 1 hour to 7 to 9 days after the first administration of the drug.

Study Arms (1)

Patients with advanced metastatic solid tumors

EXPERIMENTAL

Drug: radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI

Interventions

radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI DRUG

a novel covalent targeted radioligand (CTR), ¹⁷⁷Lu-CTR-FAPI, utilizing a sulfur(VI) fluoride exchange (SuFEx) click chemistry-based strategy

Patients with advanced metastatic solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis confirmed metastatic solid tumors (breast cancer, sarcoma, and some thyroid cancers, etc.) that failed standard treatment or lacked standard treatment
• Age: 75 ≥ age ≥ 18 years
• ECOG score: 0 - 2
• Ga-CTR-FAPI PET/CT confirmed high expression of FAP in the tumor (more than 50% of the lesions with SUVmax ≥ 10)
• The FAP immunohistochemical score of tumor cells is ≥ 2 (except for thyroid cancer)
• There is at least one measurable lesion (RECIST 1.1)
• Organ/marrow functions meet the specified thresholds, and there are no severe electrocardiogram abnormalities (QTcF ≤ 470ms)

You may not qualify if:

• There is brain metastasis or other central nervous system lesions.
• The expected survival period is less than 6 months.
• Within 4 weeks before administration, the patient has received chemotherapy, targeted therapy, immunotherapy, or other anti-tumor treatments or investigational drugs.
• The patient has previously received other systemic radionuclide therapy (excluding 131I treatment for thyroid cancer).
• There is uncontrolled pleural effusion, ascites, severe cardiovascular or cerebrovascular diseases, or infection.

Sponsors & Collaborators

• Lanzhou University Second Hospital: lead

Study Sites (1)

The Second Hospital & Clinical Medical School, Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Nuclear Medicine Department of the Second Hospital of Lanzhou University

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 14, 2026
• Study Start: November 20, 2024
• Primary Completion: March 20, 2026
• Study Completion: April 20, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)