Solid Tumor MalignanciesPhase 1NCT07045428
68Ga-GP-01 Injection in Solid Tumors Participants
A Phase 1 study testing 68Ga-GP-01 Injection in people with Solid Tumor Malignancies, run by GrandPharma (China) Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- 68Ga-GP-01 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2025to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreed to participate by providing a signed informed consent form and can comply with study-related procedures.
- Male or female aged ≥ 18 years old.
- Patients with solid tumors planned to undergo surgical resection or laparoscopic exploration and histopathology confirmation.
- 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. .
- Be capable of receiving 18F-FDG PET/CT scan.
- Adequate renal function as determined by a creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
- 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.
Who cannot join
- Any PET scan done within 10 physical half-lives of the PET agent prior to planned administration of 68Ga-GP-01.
- Exposure to any investigational agent within 4 weeks prior to the planned administration of 68Ga-GP-01.
- Major surgery, any systemic anti-cancer therapy or radiotherapy within 4 weeks prior to planned administration of 68Ga-GP-01.
- 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;
- 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.
- Planned antineoplastic therapies from time of consent to planned surgery or laparoscopic exploration.
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- Planning to participate in any drug or device clinical trial during the study period.
- Has a known or suspected allergic reaction to any components of the formulation used in 68Ga-GP-01.
- Contraindications to PET/CT scan.
- Has a medical, psychological, or social condition that, in opinion of the investigators will make it difficult to comply study procedures.
- Female participants who are pregnant or lactating.
- Other reasons determined by investigators.
About this study
Official title: An Exploratory, Single-Arm, Open-label Study of Safety, Pharmacokinetics, Biodistribution and Dosimetry of 68Ga-GP-01 Injection in Participants With Solid Tumors
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.
Read more
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.
- Conditions
- Solid Tumor Malignancies
- Being tested
- 68Ga-GP-01 Injection
- Keywords
- radiopharmaceutical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-GP-01 InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: 68Ga-GP-01 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within Day3 after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start31 Oct 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open label trial aimed at evaluating the safety, pharmacokinetics, biodistribution, dosimetry, and preliminary ability to detect metastatic disease of 68Ga-GP-01 injection in participants with solid tumors. This study contains two parallel cohorts.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GrandPharma (China) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045428
- Sponsor's protocol ID
- ST1530-1
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Single-Arm, Open-label Study of Safety, Pharmacokinetics, Biodistribution and Dosimetry of 68Ga-GP-01 Injection in Participants With Solid Tumors
- ClinicalTrials.gov ID
- NCT07045428
- Acronym / sponsor ID
- ST1530-1
- Conditions
- Solid Tumor Malignancies
- Keywords
- radiopharmaceutical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- GrandPharma (China) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open label trial aimed at evaluating the safety, pharmacokinetics, biodistribution, dosimetry, and preliminary ability to detect metastatic disease of 68Ga-GP-01 injection in participants with solid tumors. This study contains two parallel cohorts.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: 68Ga-GP-01 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Agreed to participate by providing a signed informed consent form and can comply with study-related procedures.
- Male or female aged ≥ 18 years old.
- Patients with solid tumors planned to undergo surgical resection or laparoscopic exploration and histopathology confirmation.
- 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. .
- Be capable of receiving 18F-FDG PET/CT scan.
Key exclusion criteria (12 listed)
- Any PET scan done within 10 physical half-lives of the PET agent prior to planned administration of 68Ga-GP-01.
- Exposure to any investigational agent within 4 weeks prior to the planned administration of 68Ga-GP-01.
- Major surgery, any systemic anti-cancer therapy or radiotherapy within 4 weeks prior to planned administration of 68Ga-GP-01.
- 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;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-GP-01 InjectionA 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. | Drug | Experimental Group |
Primary outcome
To evaluate the safety and tolerability of 68Ga-GP-01
Time frame: Within Day3 after dose
Number of participants with treatment emergent adverse event, with abnormal laboratory tests results and abnormal 12-lead electrocardiograms (ECGs) readings.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 68Ga-GP-01 Injection in people with Solid Tumor Malignancies, run by GrandPharma (China) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of 68Ga-GP-01 (time frame: Within Day3 after dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.