Clinical trial · Interventional
Exploratory Clinical Study of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
An Exploratory Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ¹⁷⁷Lu-CTR-FAPI in Patients With Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Solid Tumors (Any Localization) | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with advanced metastatic solid tumors
- interventionNames
- Drug: radionuclide therapy with ¹⁷⁷Lu-CTR-FAPI
Primary outcomes (3)
- measure
- Number of Participants With Treatment-Emergent Adverse Events
- timeFrame
- From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
- description
- 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.
- measure
- Number of Participants With Abnormal Vital Signs
- timeFrame
- From first administration of [¹⁷⁷Lu]Lu-CTR-FAPI through 6 weeks after the last administration
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 68Ga-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) Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available