SarcomaPhase 1NCT06508307
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors
A Phase 1 study testing A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors in people with Sarcoma and Cervical Cancer, run by GONGCHU Biotechnology Co., Ltd at 1 site in China.
Trial summary
The present trial is an open, single-arm phase I clinical study aimed at assessing the safety, tolerability, viral distribution and shedding patterns, pharmacodynamics, immunogenicity, and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcoma, Cervical Cancer, Colon Cancer
- What is being tested?
- A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2023to Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for participation in this study, individuals must meet the following criteria:
- Fully comprehend the purpose, nature, methods, and potential adverse effects of the trial, volunteer as a participant, and provide informed consent by signing the form prior to undergoing any procedures.
- Be male or female patients aged 18 to 75 years (including those with borderline age values).
- Patients with advanced solid tumors, including but not limited to: colorectal cancer, lung cancer, ovarian cancer, cervical cancer, etc., that have been histologically or cytologically diagnosed and for which there is either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).
- Possess at least one extracranial measurable lesion (as determined by a CT scan or MRI conducted no more than 4 weeks before signing the informed consent form) that is suitable for intratumoral injection based on RECIST v1.1 criteria.
- Have an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1.
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- Be expected to survive for at least 3 months.
- Within 7 days prior to receiving the first dose of treatment, patients must meet the following organ function and bone marrow reserve:
- Hematology: platelets (PLT) ≥ 80 × 109/L, neutrophil count (ANC) ≥ 1.5 × 109/L, and hemoglobin ≥ 9 g/dL (without having received adjuvants like EPO, G-CSF, or GM-CSF in the 14 days leading up to the first dose, and not having received a blood transfusion for at least 7 days);
- Coagulation function: INR ≤ 1.2, APTT ≤ 1.2 × ULN (upper limit of normal), PT ≤ 1.2 × ULN;
- Hepatic function: total bilirubin ≤ 1.5
- × ULN (patients with Gilbert syndrome may be enrolled with a total bilirubin ≤ 3 × ULN), AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN in the presence of hepatic metastases);
- Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (according to the Cockcroft-Gault formula, see Appendix 2 for details);
- Cardiac function: QT interval (QTcF) ≤ 470 ms in female and ≤ 450 ms in male.
- Ability to effectively communicate with the investigator and comprehend and adhere to the requirements of the study.
Who cannot join
- Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis and risk of death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, and other carcinomas in situ.
- Females of childbearing age who have a positive pregnancy test or are lactating.
- Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.
- Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.
- Patients who have previously received lysosomal virus, stem cell, or gene therapy products.
- Individuals using other investigational drugs or participating in clinical trials of other drugs within 28 days prior to the first dose (except for those who did not receive the test drug).
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- Those who have undergone antitumor therapy, including radiation therapy (except palliative radiotherapy), chemotherapy, biotherapy, endocrine therapy, and immunotherapy within 28 days prior to the first administration of the drug; Individuals using small molecule targeted agents with antitumor effects within 14 days prior to the first administration of the drug or within 5 times the half-life of the drug (whichever is longer); Individuals using herbal medicines with antitumor effects within 14 days prior to the first administration of the drug.
- Individuals who have undergone surgery or interventional therapy (excluding tumor biopsy, puncture, etc.), or have unhealed wounds, ulcers, or fractures within 28 days prior to the first dose.
- Individuals who have been treated with systemic corticosteroids (at a dose equivalent to >10 mg prednisone/day) or other immunosuppressive medications within 28 days prior to the first dose, or who are currently taking antiviral medications (such as ribavirin, rifampin, imatinib, etc.), enrollment is permitted under the following cases:
- short-term (≤7 days) use of corticosteroids for prophylaxis or treatment of non-autoimmune allergic diseases is permitted;
- the use of topical topical or inhaled glucocorticoids is permitted;
- patients with hepatitis B who are stable while receiving antiviral medications.
- Patients with clinically symptomatic CNS metastases or poorly controlled CNS metastases despite treatment (patients who have been stable for more than 4 weeks by MRI/CT without requiring steroidal medications or other CNS-targeted treatments for at least 4 weeks) may be eligible for enrollment.
- Individuals with clinically significant or rapidly accumulating ascites, pericardial and/or pleural effusions.
- A history of severe cardiovascular disease, including but not limited to:
- evere cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring medical intervention, II-III degree atrioventricular block, etc;
- According to the standards of the New York Heart Association (NYHA), individuals with grade III-IV heart failure;
- Recent cardiovascular events such as acute coronary syndrome, congestive heart failure, aortic dissection, stroke, cerebrovascular malformation, or other Grade 3 or higher events within the past 6 months prior to the first administration;
- Uncontrolled hypertension despite standard antihypertensive therapy, with blood pressure persistently above systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg.
- Recent Grade 3 or greater bleeding event within 6 months prior to the first use of study drug, or who have current > Grade 2 bleeding, or hemangioma/vascular malformation, or tumor stroke, tumor invasion of a blood vessel, or active peptic ulcer, or esophageal varices judged by the investigator to be at significant risk for bleeding.
- Those with a history of severe hemoptysis。
- Adverse effects from prior antineoplastic therapy that have not recovered to a CTCAE v5.0 grade rating of ≤ 1 (excluding non-risky toxicities like alopecia).
- Patients with uncontrolled or severe diseases, including but not limited to persistent or active infections requiring antibiotic therapy.
- Subjects with active or prior history of autoimmune diseases with potential for recurrence (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.) or at high risk (e.g., patients who have undergone organ transplantation requiring immunosuppressive therapy) are not eligible for enrollment. However, enrollment is permitted for subjects with:
- type 1 diabetes mellitus that is stabilized on a fixed dose of insulin;
- autoimmune hypothyroidism or Hashimoto's thyroiditis that requires only hormone replacement therapy.
- Individuals with a history of exfoliative skin conditions requiring systemic therapy (e.g., eczema or atopic dermatitis) are also excluded。
- Persons who are positive for human immunodeficiency virus (HIV) antibodies.
- Persons who have active hepatitis B (HBV)/hepatitis C (HCV) infection are not eligible for enrollment. However, subjects with a previous history of hepatitis C but negative HCV RNA at screening may be enrolled, and those who are HBsAg positive but have HBV DNA <500 IU/ml or below the lower limit of detection at the study center may also be enrolled. Subjects with primary liver cancer and HBV DNA <1000 IU/ml may be enrolled as well.
- Male and female patients who refuse to use an appropriate method of contraception, (such as the simultaneous use of spermicides, barrier contraceptives, and/or intrauterine contraceptives, as outlined in Appendix 1) throughout the study period and during the safety follow-up period are excluded.
- Patients with documented psychiatric illnesses or disorders that may impact adherence to the trial protocol.
- Patients with malignant tumors that may require antitumor therapy other than the investigational drug GC001.
- Patients who, as determined by the investigator, are unsuitable for participation in the study, including those with tumors surrounding major vascular structures such as the carotid arteries, tumors adjacent to critical neurovascular structures, or airways, or tumors in locations that present a high risk of adverse events or are unsuitable for intratumoral injections.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
luo suxia, Professor contact
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
MO guoyu, 13710803863, morlon_pla@126.com
About this study
Official title: A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Advanced Solid Tumors.
The present trial is an open, single-arm phase I clinical study aimed at assessing the safety, tolerability, viral distribution and shedding patterns, pharmacodynamics, immunogenicity, and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration.
Read the detailed description
The main objective of this study is:
To evaluate the safety and tolerability i.e. dose limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MFD) of GC001 injection in patients with advanced solid tumors.
The ongoing trial is structured as an open, single-arm Phase I clinical study. The initial phase of the study, Part I, utilizes a 3+3 design to meticulously evaluate the escalation of the dose of GC001. The total enrollment of participants will be determined by the observed toxicity levels and the extent of dose cohorts explored, with an anticipated enrollment ranging from 21 to 36 eligible individuals. A critical 28-day period post-administration has been established for the observation of dose-limiting toxicities (DLTs) to ensure participant safety. It is essential to maintain this standardized 28-day observation window for all enrolled groups to uphold the highest safety standards.
The secondary aims of this investigation are to assess the biodistribution and shedding of the virus, the pharmacodynamic characteristics, immunogenicity, and the initial antitumor efficacy of the GC001 injection in patients suffering from advanced solid tumors. These objectives are integral to understanding the broader impact and potential of the treatment in this patient population.
Following the completion of the DLT assessment for all participants within each dose cohort, the SMC may decide whether to proceed with dose escalation, explore intermediate/higher doses, or terminate the dose escalation study based on the data obtained on safety, tolerability, biodistribution, and shedding of the virus (if any), pharmacodynamics (if any), immunogenicity (if any), and antitumor activity (if any). The SMC may also decide to adjust doses, administration schedules, and the time of biospecimen collection.
- Conditions
- Sarcoma, Cervical Cancer, Colon Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- Being tested
- A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors
- Keywords
- GC001、Oncolytic virus 、WR
- Medical subject headings
- Sarcoma, Uterine Cervical Neoplasms, Colonic Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Carcinoma, Hepatocellular, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid TumorsBiological
The maximum number of lesions that each participant is allowed to inject at one time is two.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | The study consists of a total of six dose groups, with the lowest dose group being 3×10^6 and the highest dose reaching 1×10^9 PFU. In case the maximum dose of 1×10^9 PFU fails to achieve the Maximum Tolerated Dose (MTD), the Safety Monitoring Committee (SMC) will convene to discuss whether to designate it as Maximum Feasible Dose (MFD) or consider escalating further based on current safety and preliminary efficacy data. However, any escalation beyond that of similar drugs' Phase I clinical trials, such as JX-594:NCT00629759 and JX-929:NCT00574977, where the highest administered dose was 3×10^9 PFU, shall be avoided. This precaution ensures adherence to established safety protocols.
A single dose of GC001 will be administered up to 4mL (The injection volume is based on the length of the lesion). Receives: Biological: A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of GC001
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs)，treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Measured: DLT Observation Period，Up to 28 days from GC001 injection
Maximal tolerable dose
During the DLT observation period, the number of cases with DLT is less than or equal to the maximum dose of 1/6 of the total number of cases, and six evaluable participants are required to determine MTD.
Measured: DLT Observation Period,Up to 28 days from GC001 injection
Secondary outcomes (4)
Anti-tumor activity of GC001: overall response rate (ORR).
To evaluate the overall response rate (ORR) as a measurement of tumor response and disease progression.
Measured: Up to 2 years
Anti-tumor activity of GC001: duration of response (DOR).
To evaluate the duration of response (DOR) as a measurement of tumor response and disease progression.
Measured: Up to 2 years from GC001 injection
Anti-tumor activity of GC001:progression-free survival (PFS).
To evaluate the progression-free survival (PFS) as a measurement of tumor response and disease progression.
Measured: Up to 2 years from GC001 injection
Evaluate the viral biological distribution and shedding of GC001
Viral biodistribution and shedding analysis for GC001 injection are performed based on the viral Biodistribution and shedding Analysis Set (BVSS). Biological collection samples include blood, urine, throat swabs, injection site and injection site dressing samples (for tumor injection at the percutaneous puncture site only),and determination of viral DNA copy number in the above samples.
Measured: Up to 2 years from GC001 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start26 Apr 2023
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3+3
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GONGCHU Biotechnology Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- li gongchu, Professor, Principal investigator, GONGCHU Biotechnology Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508307
- Sponsor's protocol ID
- GONGCHU
- Status last verified
- Aug 2025
- First submitted
- 26 Jun 2024
- Last updated
- 21 Aug 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 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06508307
- Acronym / sponsor ID
- GONGCHU
- Conditions
- Sarcoma, Cervical Cancer, Colon Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- Keywords
- GC001、Oncolytic virus 、WR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- GONGCHU Biotechnology Co., LtdUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Jul 2024 (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.
The present trial is an open, single-arm phase I clinical study aimed at assessing the safety, tolerability, viral distribution and shedding patterns, pharmacodynamics, immunogenicity, and antitumor efficacy of GC001 oncolytic virus injection in patients with advanced solid tumors following a single administration.
Detailed description
The main objective of this study is:
To evaluate the safety and tolerability i.e. dose limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MFD) of GC001 injection in patients with advanced solid tumors.
The ongoing trial is structured as an open, single-arm Phase I clinical study. The initial phase of the study, Part I, utilizes a 3+3 design to meticulously evaluate the escalation of the dose of GC001. The total enrollment of participants will be determined by the observed toxicity levels and the extent of dose cohorts explored, with an anticipated enrollment ranging from 21 to 36 eligible individuals. A critical 28-day period post-administration has been established for the observation of dose-limiting toxicities (DLTs) to ensure participant safety. It is essential to maintain this standardized 28-day observation window for all enrolled groups to uphold the highest safety standards.
The secondary aims of this investigation are to assess the biodistribution and shedding of the virus, the pharmacodynamic characteristics, immunogenicity, and the initial antitumor efficacy of the GC001 injection in patients suffering from advanced solid tumors. These objectives are integral to understanding the broader impact and potential of the treatment in this patient population.
Following the completion of the DLT assessment for all participants within each dose cohort, the SMC may decide whether to proceed with dose escalation, explore intermediate/higher doses, or terminate the dose escalation study based on the data obtained on safety, tolerability, biodistribution, and shedding of the virus (if any), pharmacodynamics (if any), immunogenicity (if any), and antitumor activity (if any). The SMC may also decide to adjust doses, administration schedules, and the time of biospecimen collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Biological: A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid TumorsThe study consists of a total of six dose groups, with the lowest dose group being 3×10^6 and the highest dose reaching 1×10^9 PFU. In case the maximum dose of 1×10^9 PFU fails to achieve the Maximum Tolerated Dose (MTD), the Safety Monitoring Committee (SMC) will convene to discuss whether to designate it as Maximum Feasible Dose (MFD) or consider escalating further based on current safety and preliminary efficacy data. However, any escalation beyond that of similar drugs' Phase I clinical trials, such as JX-594:NCT00629759 and JX-929:NCT00574977, where the highest administered dose was 3×10^9 PFU, shall be avoided. This precaution ensures adherence to established safety protocols. A single dose of GC001 will be administered up to 4mL (The injection volume is based on the length of the lesion). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- To be eligible for participation in this study, individuals must meet the following criteria:
- Fully comprehend the purpose, nature, methods, and potential adverse effects of the trial, volunteer as a participant, and provide informed consent by signing the form prior to undergoing any procedures.
- Be male or female patients aged 18 to 75 years (including those with borderline age values).
- Patients with advanced solid tumors, including but not limited to: colorectal cancer, lung cancer, ovarian cancer, cervical cancer, etc., that have been histologically or cytologically diagnosed and for which there is either no current standard of care or the standard treatment has proven ineffective (progression of the disease after treatment or intolerance of treatment).
- Possess at least one extracranial measurable lesion (as determined by a CT scan or MRI conducted no more than 4 weeks before signing the informed consent form) that is suitable for intratumoral injection based on RECIST v1.1 criteria.
Key exclusion criteria (33 listed)
- Patients with a previous diagnosis of any other malignancy within 5 years prior to the first dose, except for malignancies with a low risk of metastasis and risk of death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, and other carcinomas in situ.
- Females of childbearing age who have a positive pregnancy test or are lactating.
- Individuals with allergies (defined as ≥2 drug allergies) or hypersensitivity to similar products or excipients.
- Those who have received smallpox vaccination and experienced severe systemic reactions or side effects.
- Patients who have previously received lysosomal virus, stem cell, or gene therapy products.
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 |
|---|---|---|
| A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid TumorsThe maximum number of lesions that each participant is allowed to inject at one time is two. | Biological | Part 1: Dose Escalation |
Primary outcome
Evaluate the safety and tolerability of GC001
Time frame: DLT Observation Period，Up to 28 days from GC001 injection
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs)，treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Maximal tolerable dose
Time frame: DLT Observation Period,Up to 28 days from GC001 injection
During the DLT observation period, the number of cases with DLT is less than or equal to the maximum dose of 1/6 of the total number of cases, and six evaluable participants are required to determine MTD.
4 secondary outcomes
Anti-tumor activity of GC001: overall response rate (ORR).
Time frame: Up to 2 years
Anti-tumor activity of GC001: duration of response (DOR).
Time frame: Up to 2 years from GC001 injection
Anti-tumor activity of GC001:progression-free survival (PFS).
Time frame: Up to 2 years from GC001 injection
Evaluate the viral biological distribution and shedding of GC001
Time frame: Up to 2 years from GC001 injection
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 21 Aug 2025.
- Individual participant dataSharing planned: No
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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.
luo suxia, Professor contact
li gongchu, Professor principal investigator
GONGCHU Biotechnology Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patients With Advanced Solid Tumors in people with Sarcoma and Cervical Cancer, run by GONGCHU Biotechnology Co., Ltd at 1 site in China.
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 15 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Mo guoyu (13710803863, morlon_pla@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of GC001 (time frame: DLT Observation Period，Up to 28 days from GC001 injection). The study lists 2 primary outcomes in all. 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 21 Aug 2025.