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NCT07045428
68Ga-GP-01 Injection in Solid Tumors Participants
Phase 1 trial testing 68Ga-GP-01 Injection in Solid Tumor Malignancies in 20 participants. Not yet recruiting.
30 June 2026
Quick facts
| Lead sponsor | GrandPharma (China) Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 20 |
| Start date | 31 October 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 November 2026 |
Drugs / interventions tested
- 68Ga-GP-01 Injection — full drug profile →
Conditions studied
- Solid Tumor Malignancies — all drugs for Solid Tumor Malignancies →
Sponsor
GrandPharma (China) Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Solid Tumor Malignancies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A company named Chengdu Shetai Medical Technology Co., Ltd. is conducting a research study to test a new type of scan for detecting solid tumors in patients who are scheduled for surgery. During the scan, the investigators will use a special experimental drug called 68Ga-GP-01 Injection, which is given through a vein (IV). This drug isn't yet approved by the TGA for this use. The scan works by targeting a protein called FAP that's often found in high amounts in tumor tissues. FAP is mainly present in cells surrounding tumors, but sometimes in cancer cells themselves too - especially in certain cancers like ovarian, breast, pancreatic, and some sarcomas. Researchers think this could be useful for both diagnosis and potential future treatments. The GP-01 molecule is combined with a radioactive material (Gallium-68) that shows up on PET scans - a special imaging technique that can spot cancer cells in the body. Currently, CT scans are the most common way to check for tumors before surgery. A PET/CT machine combines both technologies - it can show both the structure of participant's organs (CT) and detect cancer cells that have absorbed the radioactive tracer (PET). In this study, the investigators want to see if 68Ga-GP-01 works better than standard PET/CT scans at finding tumors. After participant's surgery, the investigators will compare our scan results with participant's pathology report (the most accurate way to diagnose cancer) to check how accurate our method was. Important: This is NOT a treatment for participant's cancer - it's just testing a new way to detect tumors. About 20 patients at 4 Australian hospitals will participate. If participant is willing to join, participant's involvement will last about 2 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07045428
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other GrandPharma (China) Co., Ltd. trials
Trials by the same sponsor.
- NCT07334483 — A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC · Phase 2 · recruiting
- NCT06712017 — Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China · enrolling by invitation
- NCT06079242 — Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Color · not yet recruiting
- NCT05188417 — A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke · Phase 2 · unknown
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 NCT07045428 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GrandPharma (China) Co., Ltd.
- Last refreshed: 3 July 2025
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