Who is sponsoring NCT05814835?

NCT05814835 is sponsored by Chinese PLA General Hospital.

What drugs are being tested in NCT05814835?

Interventions in NCT05814835: 2-4 mCi 68Ga/64Cu-FAPI-XT117, 4-6 mCi 68Ga/64Cu-FAPI-XT117, 6-8 mCi 68Ga/64Cu-FAPI-XT117.

What condition does NCT05814835 study?

NCT05814835 studies Malignant Solid Tumors.

Is NCT05814835 still recruiting?

NCT05814835 is currently completed. Last updated 20 December 2023.

Last reviewed 2023-12-20 · How we verify

NCT05814835

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

Completed Phase 1 Last updated 20 December 2023

What this trial tests

Phase 1 trial testing 2-4 mCi 68Ga/64Cu-FAPI-XT117 in Malignant Solid Tumors in 14 participants. Completed in 18 December 2023.

Timeline

7 December 2022

Primary endpoint
30 November 2023

18 December 2023

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	14
Start date	7 December 2022
Primary completion	30 November 2023
Estimated completion	18 December 2023
Sites	1 location across China

Drugs / interventions tested

2-4 mCi 68Ga/64Cu-FAPI-XT117 — full drug profile →
4-6 mCi 68Ga/64Cu-FAPI-XT117 — full drug profile →
6-8 mCi 68Ga/64Cu-FAPI-XT117 — full drug profile →

Conditions studied

Malignant Solid Tumors — all drugs for Malignant Solid Tumors →

Sponsor

Chinese PLA General Hospital

Who can join

18 and older, any sex, with Malignant Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

<i>CopperNostics</i>-Here We Are Now, Entertain Us!
Brühlmann SA, Walther M, Kopka K, Kreller M, et al · · 2026 · PMID 41754861 · DOI 10.3390/ph19020321
Safety and efficacy of <sup>177</sup>Lu-FAPI-XT radioligand therapy in patients with advanced sarcoma and other cancer entities: first-in-human, dose-escalation study.
Liu H, Guo R, Zhang X, Ji H, et al · · 2026 · PMID 41087606 · DOI 10.1007/s00259-025-07617-0

Verify or expand the search:

Other recruiting trials for Malignant Solid Tumors

Currently open trials in the same condition.

NCT06629584 — Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia · Phase 2 · recruiting
NCT06702566 — The Effect of Serum Ferritin in irAE · NA · recruiting
NCT05579275 — Evaluate the Safety and Tolerability of JCXH-212 Monotherapy and Combined With Toripalimab in the Treatment of Malignant · EARLY_PHASE1 · recruiting
NCT03739827 — Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors · recruiting

Other Chinese PLA General Hospital trials

Trials by the same sponsor.

NCT07294755 — The Impact of Intrapleural Block on Postoperative Pain Caused by Drainage Tubes After Thoracoscopic Surgery · NA · not yet recruiting
NCT07536607 — Predictive Role of Photon Counting Computed Tomography in Acute Coronary Syndrom Patients · not yet recruiting
NCT07489157 — Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy · NA · not yet recruiting
NCT07494981 — Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations · not yet recruiting
NCT07496008 — Individualized Precision Isavuconazole Therapy Guided by PK/PD Principles for the Geriatric Population · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05814835 (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 Chinese PLA General Hospital
Last refreshed: 20 December 2023

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/NCT05814835.

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