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NCT06636617
177Lu-JH04 in Patients with FAP-Positive Tumors
EARLY_PHASE1 trial testing 3.70 GBq (100 mCi) of 177Lu-JH04 in Patients with Advanced Metastatic FAP-Positive Tumors in 9 participants. Currently enrolling.
31 August 2025
Quick facts
| Lead sponsor | First Affiliated Hospital of Fujian Medical University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 21 August 2024 |
| Primary completion | 31 August 2025 |
| Estimated completion | 31 August 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- 3.70 GBq (100 mCi) of 177Lu-JH04 — full drug profile →
- 5.55 GBq (150 mCi) of 177Lu-JH04 — full drug profile →
- 7.40 GBq (200 mCi) of 177Lu-JH04 — full drug profile →
Conditions studied
- Patients with Advanced Metastatic FAP-Positive Tumors — all drugs for Patients with Advanced Metastatic FAP-Positive Tumors →
Sponsor
First Affiliated Hospital of Fujian Medical University
Who can join
Adults 18 to 80, any sex, with Patients with Advanced Metastatic FAP-Positive Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic potential of FAPI RLT in oncology: A systematic review.
Ruzzeh S, Abdlkadir AS, Paez D, Kang KW, et al · · 2025 · cited 18× · PMID 40213678 · DOI 10.7150/thno.106108 -
Recent Advances in PET and Radioligand Therapy for Lung Cancer: FDG and FAP.
Lee EJ, Chung HW, So Y, Kim IA, et al · · 2025 · cited 1× · PMID 40805245 · DOI 10.3390/cancers17152549 -
Bridging the gaps in fibroblast activation protein targeted radionuclide therapy: a translational perspective.
Wu C, Kurniawan A, Ming Z, Antunes IF, et al · · 2026 · PMID 41622307 · DOI 10.1007/s00259-025-07711-3 -
Recent clinical advances in fibroblast activation protein targeted radioligand therapy for solid tumors.
Wu X, Wang Y, Li Y, Hu W. · · 2025 · PMID 41425958 · DOI 10.3389/fnume.2025.1737443
Verify or expand the search:
- PubMed search for NCT06636617
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06636617 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital of Fujian Medical University
- Last refreshed: 10 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06636617.
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