CClinicalTrials.gg
Not yet recruitingNCT07045428Updated Jul 3, 2025

68Ga-GP-01 Injection in Solid Tumors Participants

A Phase 1 interventional study of 68Ga-GP-01 Injection in Solid Tumor Malignancies, sponsored by GrandPharma (China) Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by GrandPharma (China) Co., Ltd. · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Solid Tumor Malignancies

Keywords

  • radiopharmaceutical
03

In context

Lead sponsor

GrandPharma (China) Co., Ltd. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Agreed to participate by providing a signed informed consent form and can comply with study-related procedures.
  2. Male or female aged ≥ 18 years old.
  3. Patients with solid tumors planned to undergo surgical resection or laparoscopic exploration and histopathology confirmation.
  4. Available CT/MRI images of suspected metastatic regions of cohort 1 patients; available CT/MRI images of both primary and metastatic regions of cohort 2 patients. .
  5. Be capable of receiving 18F-FDG PET/CT scan.
  6. Adequate renal function as determined by a creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
  7. Females of childbearing potential must have a negative pregnancy test.. Male and female participants of childbearing potential must use at least 2 highly effective forms of contraception, one of which must be a barrier method, or agree to remain abstinent for duration of study participation and for 3 months following Ga agent.

Exclusion criteria

Exclusion Criteria:

  1. Any PET scan done within 10 physical half-lives of the PET agent prior to planned administration of 68Ga-GP-01.
  2. Exposure to any investigational agent within 4 weeks prior to the planned administration of 68Ga-GP-01.
  3. Major surgery, any systemic anti-cancer therapy or radiotherapy within 4 weeks prior to planned administration of 68Ga-GP-01.
  4. Past or current history of another malignancy, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 3 years;
  5. Co-morbidities (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator could compromise patient safety and/or protocol objectives.
  6. Planned antineoplastic therapies from time of consent to planned surgery or laparoscopic exploration.
  7. Planning to participate in any drug or device clinical trial during the study period.
  8. Has a known or suspected allergic reaction to any components of the formulation used in 68Ga-GP-01.
  9. Contraindications to PET/CT scan.
  10. Has a medical, psychological, or social condition that, in opinion of the investigators will make it difficult to comply study procedures.
  11. Female participants who are pregnant or lactating.
  12. Other reasons determined by investigators.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    Drug: 68Ga-GP-01 Injection

Interventions

  • Drug68Ga-GP-01 Injection

    A certain mass dose of 68Ga-GP-01 will be used in this study, and the radiation dose will be no more than, enabling all participants will receive a radiation dose of 5±2 mCi in the study.

06

What researchers measure

Primary outcomes

  1. To evaluate the safety and tolerability of 68Ga-GP-01

    Number of participants with treatment emergent adverse event, with abnormal laboratory tests results and abnormal 12-lead electrocardiograms (ECGs) readings.

    Time frame: Within Day3 after dose

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07045428
Lead sponsor
GrandPharma (China) Co., Ltd.
Responsible party
Sponsor
First posted
Jul 1, 2025
Start date
Oct 31, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Jul 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion