Clinical trial · Interventional
177Lu-JH04 in Patients with FAP-Positive Tumors
Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
NCT06636617CI-TRIAL-00081495recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively an approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi) and 7.40 GBq (200 mCi) of 177Lu-JH04 up to 4 cycles.
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 |
|---|---|---|---|
| Patients with Advanced Metastatic FAP-Positive Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3.70 GBq (100 mCi) of 177Lu-JH04 | Drug | — | UNRESOLVED |
| 5.55 GBq (150 mCi) of 177Lu-JH04 | Drug | — | UNRESOLVED |
| 7.40 GBq (200 mCi) of 177Lu-JH04 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 3.70 GBq (100 mCi) of 177Lu-JH04
- description
- All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.
- interventionNames
- Drug: 3.70 GBq (100 mCi) of 177Lu-JH04
- type
- EXPERIMENTAL
- label
- 5.55 GBq (150 mCi) of 177Lu-JH04
- description
- All 3 patients were intravenous injected with single dose 5.55 GBq (150 mCi) of 177Lu-JH04.
- interventionNames
- Drug: 5.55 GBq (150 mCi) of 177Lu-JH04
- type
- EXPERIMENTAL
- label
- 7.40 GBq (200 mCi) of 177Lu-JH04
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * progressive advanced metastatic tumors * tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT * adequate renal, haematological, and liver function * an Eastern Cooperative Oncology Group performance status of 0-2 Exclusion Criteria: * pregnant or lactating women * received other radionuclide therapy in the past 6 months * received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days
References
Publications (0)
Data not yet available
No reference posted for this study.