Solid Tumor MalignanciesPhase 1NCT07748117
A Clinical Study of GO321 in Patients With Advanced Solid Tumors
A Phase 1 study testing GO321 in people with Solid Tumor Malignancies, run by GeneSail Biotech (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the safety and tolerability of GO321 recombinant oncolytic virus injection, and if GO321 recombinant oncolytic virus injection works to treat advanced solid tumors in adults whose cancers have progressed after standard-of-care therapy. 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?
- GO321
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 31 Dec 2028
- 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
- Age 18 years old and above, regardless of gender.
- Histologically or cytologically confirmed advanced malignant solid tumors that are refractory to or have failed standard therapy (including disease progression and/or intolerance to toxicity), or for which no standard therapy is available.
- For patients with malignant ascites secondary to malignant tumors (e.g., ovarian cancer, gastrointestinal solid malignancies) who are planned to receive intracavitary injection, the following criteria must be met:
- a. Malignant ascites is determined by the investigator to be caused by cancer cell dissemination, and not complicated by ascites due to other etiologies;
- b. Recurrence of ≥ Grade 2 ascites within 4 weeks after at least one prior local therapy (including paracentesis, intraperitoneal chemotherapy, peritoneovenous shunt, hyperthermic intraperitoneal chemotherapy, etc.);
- c. Large-volume peritoneal effusion confirmed by computed tomography (CT) or ultrasound, with a clinical indication for local therapeutic intervention targeting the ascites.
Show all 15Show fewer
- Patients scheduled for intratumoral injection must meet the following requirements: At least one evaluable lesion confirmed by local imaging per RECIST v1.1 that is amenable to intratumoral injection. A lesion suitable for intratumoral injection (with or without CT/ultrasound guidance) is defined as a palpable mass or a mass visible by CT/ultrasound that can be injected under CT/ultrasound guidance, located in the skin, subcutaneous tissue, or deep-seated regions, with a longest diameter ≥ 1.0 cm (or short axis ≥ 1.5 cm if a lymph node), and deemed appropriate for intratumoral injection by the investigator. If the injection site has been previously irradiated, eligibility may be considered after discussion with the sponsor.
- Eastern Cooperative Oncology Group (ECOG) score ≤2.
- Expected survival time ≥3 months.
- Study participants had adequate organ function at screening/baseline, and the laboratory indicators met the following criteria:
- a. Hematopoietic system (no previous blood transfusion or hematopoietic stimulating factor therapy within 14 days) : absolute neutrophil count (ANC) ≥1.5E+09/L; Hemoglobin (Hgb) ≥90g/L; Platelet count (Plt) ≥75E+09/L.
- b. Liver function: serum total bilirubin (TBIL) ≤1.5×ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN, with liver metastasis TBIL≤3×ULN, ALT and AST≤5×ULN; Serum albumin ≥2.8 g/dL (Subjects may receive albumin supplementation to meet these laboratory criteria).
- c. Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (according to Cockroft-Gault formula) >50mL/min.
- d. Coagulation: international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Study participants were willing and able to comply with protocol requirements for the duration of the trial, including but not limited to receiving treatment, use effective contraception throughout trial participation and for 6 months after the last study drug administration, and undergoing regular follow-up and examinations.
Who cannot join
- Female participants who were pregnant or lactating.
- Presence of another malignancy within the previous 2 years, except for cancers with a low risk of metastasis and death (5-year survival rate, >90%), such as adequately treated basal-cell or squamous-cell skin cancer or carcinoma in situ of the cervix and other cancers in situ.
- Adverse events from prior anti-tumor therapy have not recovered to Grade ≤ 1 per CTCAE v6.0, or to the levels specified in the inclusion/exclusion criteria (with the exception of alopecia, skin hyperpigmentation, or other toxicities deemed by the investigator to have no safety risk). Participants with chronic Grade 2 toxicity may be eligible after discussion with the sponsor, provided the toxicity is asymptomatic or adequately controlled with stable medications.
- Received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product; received oral fluoropyrimidines or small-molecule targeted agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose; received traditional Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose; received other systemic anti-tumor therapies, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose.
- Presence of any of the following infections or diseases:
- a. Active hepatitis B (HBsAg positive and/or HBcAb positive with an HBV DNA test value greater than the upper limit of normal); Active hepatitis C (anti-HCV antibody positive for further HCV RNA positive).
Show all 32Show fewer
- b. A known history of immunodeficiency virus (HIV) disease or HIV antibody positive or active syphilis.
- c. Evidence of clinically significant immunodeficiency such as a primary immunodeficiency state such as severe combined immunodeficiency (SCID); Opportunistic bacterial infection.
- Have a history of active autoimmune disease requiring systemic therapy such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or have been receiving long-term systemic steroids (prednisone >10 mg/ day or equivalent dose of the same drug) or any other form of immunosuppressive therapy within 14 days before the first use of the investigational drug. The following patients are NOT excluded:
- a. Subjects with clinically stable autoimmune thyroid disease
- b. Patients receiving topical/inhaled corticosteroids (ocular, intra-articular, intranasal formulations)
- c. Short-course glucocorticoids (≤3 days) used prophylactically (e.g., contrast allergy prevention)
- d. Patients receiving physiological hormone replacement doses.
- Received allogeneic tissue or solid organ transplantation.
- A history of severe cardiovascular and cerebrovascular disease, including but not limited to:
- a. New York Heart Association (NYHA) class ≥II congestive heart failure.
- b. left ventricular ejection fraction (LVEF) <50%.
- c. QT interval corrected with Fridericia's method (QTcF) >470 ms or syndrome of prolonged QT interval.
- d. Acute coronary syndrome, aortic dissection, major arrhythmia, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first dose.
- e. Presence of uncontrolled hypertension despite treatment (systolic BP>160 mmHg or diastolic BP>100 mmHg, as judged by the investigator).
- f. Occurrence of Grade ≥ 3 bleeding events within 6 months prior to the first dose; or current presence of > Grade 2 bleeding, hemangioma/vascular malformation, tumor apoplexy, tumor invasion of blood vessels, or active gastrointestinal ulcer, esophageal varices, or central nervous system (CNS) metastases with intracranial lesions that have potential bleeding risk, as determined by the investigator to have a significant risk of hemorrhage.
- History of severe skin diseases requiring systemic therapy within the past 2 years, such as eczema, atopic dermatitis, burns, seborrheic dermatitis, psoriasis, severe acne, etc.
- Patients with history of hypersensitivity or anaphylactic reactions (including immediate severe hypersensitivity reactions) of CTCAE v6.0 Grade > 3 following prior use of any drug or biologic product.
- Requirement for anticoagulant or antiplatelet therapy that cannot be interrupted prior to intratumoral injection, including: aspirin that cannot be discontinued within 7 days prior to injection; coumarins that cannot be discontinued within 7 days prior to injection; direct thrombin inhibitors (dabigatran) or direct Factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban) that cannot be discontinued within 4 days prior to injection; low-molecular-weight heparin (LMWH) that cannot be discontinued within 24 hours prior to injection; and unfractionated heparin (UFH) that cannot be discontinued for more than 4 hours prior to injection.
- Use of immunomodulatory agents within 14 days prior to the first dose of the investigational product, including but not limited to thymosin, IL-2, IFN, etc.
- Presence of other conditions requiring systemic anti-infective treatment within 4 weeks prior to the first dose of the investigational product, or active local infection at the target lesion intended for injection within 4 weeks prior to the first dose, including but not limited to hospitalization due to infectious complications, bacteremia, severe pneumonia, or active tuberculosis.
- Receipt of other investigational drugs or therapies not yet approved for marketing within 4 weeks prior to the first dose of the investigational product, or receipt of live or live-attenuated vaccines within 4 weeks prior to the first dose.
- Study participants who had undergone major surgery requiring hospitalization within 4 weeks before the first use of the investigational drug, or who were expected to undergo major surgery during the trial.
- Inability to discontinue concomitant use of sensitive substrate drugs with a narrow therapeutic index that are metabolized by CYP450 enzymes within 5 half-lives prior to the first dose of the investigational product.
- Any known mental illness or substance abuse that may interfere with the participant's ability to cooperate with the trial.
- According to the evaluation of the investigators, the treatment risks are high, including but not limited to the high risk of bleeding, possible damage to the surrounding important tissue structures, the risk of shock caused by dizzy with blood and needles, and the risk of aggravating local infection.
- If study participants plan to participate in another clinical trial during the trial period, plan to leave the trial site, or otherwise are not suitable for participation in the trial as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Ning Li, Doctor
About this study
Official title: A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of GO321 Recombinant Oncolytic Virus Injection in Patients With Advanced Refractory Solid Tumors.
The goal of this clinical trial is to learn about the safety and tolerability of GO321 recombinant oncolytic virus injection, and if GO321 recombinant oncolytic virus injection works to treat advanced solid tumors in adults whose cancers have progressed after standard-of-care therapy. It will also learn about the pharmacokinetic features, viral shedding, immunogenicity of GO321, immune markers, and genomic and proteomic changes in patients. The main questions it aims to answer are: What safety issues and tolerability limitations do participants experience when receiving GO321 via intratumoral or intracavitary injection? Does GO321 have preliminary anti-tumor efficacy against advanced solid tumors resistant to standard treatment? What changes take place in viral distribution, viral shedding, immunity, blood immune markers, tumor or blood genomics and proteomics after GO321 administration? Researchers will assess different doses and dosing schedules of GO321 given by intratumoral or intracavitary injection across two study phases to find a suitable administration dose and regimen and verify the study endpoints.
Participants will:
Receive either a single injection of GO321 at different dose levels (in Part 1) or repeated GO321 injections at the recommended Phase 2 dose (in Part 2) by intratumoral or intracavitary routes; Complete scheduled hospital visits to undergo laboratory tests, imaging examinations and biological sample collection; Have their safety indicators, anti-tumor response, viral parameters, immune indicators and molecular profiles tracked throughout the study.
Read the detailed description
This study adopts a single-arm, open-label, dose-escalation design to investigate the safety, tolerability, and preliminary efficacy of GO321 recombinant oncolytic virus injection via intratumoral or intracavitary administration in patients with advanced solid tumors progressing after standard-of-care (SOC) therapy. The trial consists of two parts: a single-dose escalation phase and a multiple-dose expansion phase.
Part 1: Single-Dose Escalation The primary Objectives: To evaluate the safety and tolerability of single intratumoral or intracavitary GO321 injection at varying dose levels in SOC-refractory advanced solid tumor patients, and identify the Recommended Dose (RD) of intratumoral/intracavitary administration for Phase 2..
The secondary Objectives: 1) To evaluate the pharmacokinetic (PK) profile and viral shedding of GO321 following single intratumoral/intracavitary administration; 2) To evaluate the preliminary efficacy of GO321; 3) To evaluate the immunogenicity of GO321; 4) To monitor peripheral blood pharmacodynamic immunological markers related to T-lymphocyte subsets and changes in plasma cytokines (as applicable).
The exploratory Objectives: To assess changes in genomic or proteomic profiles in tumor tissue or peripheral blood (as applicable).
Part 2: Multiple-Dose Expansion The Main Objectives is to evaluate the safety and tolerability of multiple intratumoral (or intracavitary) injections of GO321 at the RD level in SOC-refractory advanced solid tumor patients, and determine the optimal dosing regimen.
The secondary Objectives: 1) To evaluate the pharmacokinetic (PK) profile and viral shedding of GO321 following multiple intratumoral/intracavitary administrations; 2) To evaluate the preliminary efficacy of GO321; 3) To evaluate the immunogenicity of GO321; 4) To monitor peripheral blood pharmacodynamic immunological markers related to T-lymphocyte subsets and changes in plasma cytokines (as applicable).
The exploratory Objectives: To assess changes in genomic or proteomic profiles in tumor tissue or peripheral blood (as applicable).
- Conditions
- Solid Tumor Malignancies
- Being tested
- GO321
- Keywords
- GO321, Solid tumor malignancies, Oncolytic Viral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GO321Drug
Part 1: 3+3 Single-Dose Escalation Phase： This phase adopts a standard 3+3 dose-escalation design. GO321 is administered via intratumoral or intracavitary single injection, with the dose escalating progressively within the range of 3.0E+07 PFU to 1.0E+09 PFU. Each dose cohort will enroll 3 subjects, and all enrolled subjects will receive a single initial administration of the study drug.
Part 2: Multiple-Dose Expansion Phase： This expansion phase is conducted at the recommended dose (RD) level, aiming to explore the preliminary anti-tumor efficacy of GO321 in specific tumor types. A total of 9 subjects with specific tumor types will be enrolled in this cohort. GO321 is administered via intratumoral or intracavitary injection on a once-weekly (QW) or once-every-two-weeks (Q2W) dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| GO321 Treatment | Experimental | This is a single-arm, non-randomized study which comprises two parts: - Part 1: A 3+3 single-dose escalation phase to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicities (DLTs), and Recommended Dose (RD) of the investigational product. - Part 2: A multiple-dose expansion phase at the RD level to explore preliminary efficacy in specific tumor types. Receives: Drug: GO321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
Adverse events (AEs) will be graded according to the CTCAE Version 6.0 published by the U.S. National Cancer Institute.
Measured: Up to 6 months after the last GO321 administration
SAEs
Serious Adverse events (SAEs) will be graded according to the CTCAE Version 6.0 published by the U.S. National Cancer Institute.
Measured: Up to 6 months after the last GO321 administration.
DLT
The Dose-Limiting Toxicities (DLTs) assessed using the NCI CTCAE v6.0.
Measured: within 28 days after the first GO321 administration.
RD
The Recommended Dose (RD) will be determined based on the integrated analysis of Part 1 (3+3 dose-escalation phase) results.
Measured: Through study of Part 1 completion, an average of 9 months.
Secondary outcomes (8)
Pharmacokinetics/Viral Shedding
Concentrations of GO321 (viral genome copy numbers ) in blood, throat swab, urine, saliva, stool, and injection-site samples collected at various time points after a single dose (in part 1) or multiple dose (in part 2), and concentrations of GO321 expression products in peripheral blood.
Measured: Within 28 Days after the last GO321 administration
ORR
Objective Response Rate (ORR)(Basd on the RECIST V1.1and iRECIST): The proportion of trial participants achieving best overall response of Complete Response (CR) or Partial Response (PR) (i.e., CR+PR) from the first dose administration until study withdrawal.
Measured: Up to 5 years after the last GO321 administration.
DCR
Disease control rate (Basd on the RECIST V1.1and iRECIST): The proportion of trial participants achieving disease response or stable disease after treatment
Measured: Up to 5 years after the last GO321 administration.
PFS
Progression-Free Survival (PFS)(Basd on the RECIST V1.1and iRECIST): The time from the first dose administration to Progressive Disease (PD) or death from any cause, whichever occurs earlier
Measured: Up to 5 years after the last GO321 administration.
DOR
Duration of Response (DOR)(Basd on the RECIST V1.1and iRECIST): The time from the first documentation of CR or PR to PD or death from any cause, whichever occurs earlier.
Measured: Up to 5 years after the last GO321 administration.
OS
Overall Survival (OS)(Basd on the RECIST V1.1 and iRECIST): Time interval from the date of first study drug administration to the date of death due to any cause.
Measured: Up to 5 years after the last GO321 administration.
Pharmacodynamics/Immunological Markers
eripheral blood T lymphocyte subsets (CD3+, CD4+, CD8+, CD4+/CD8+ ratio, CD19+, etc., as applicable); plasma cytokines (IL-2, IFN-γ, granzyme B, perforin, IL-10, TGF-β1, etc., as applicable)
Measured: Within 28 days after the last GO321 administration
Immunogenicity indicators
Anti-GO321 antibodies, anti-GO321 expression product antibodies, and/or neutralizing antibodies (if applicable);
Measured: Within 28 days after the last GO321 administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, non-randomized study which comprises two parts: * Part 1: A 3+3 single-dose escalation phase to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicities (DLTs), and Recommended Dose (RD) of the investigational product. * Part 2: A multiple-dose expansion phase at the RP2D level to explore preliminary efficacy in specific tumor types.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneSail Biotech (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748117
- Sponsor's protocol ID
- GOWELL-321-1A
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 5 Aug 2026
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of GO321 Recombinant Oncolytic Virus Injection in Patients With Advanced Refractory Solid Tumors.
- ClinicalTrials.gov ID
- NCT07748117
- Acronym / sponsor ID
- GOWELL-321-1A
- Conditions
- Solid Tumor Malignancies
- Keywords
- GO321, Solid tumor malignancies, Oncolytic Viral Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- GeneSail Biotech (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Aug 2026 (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 goal of this clinical trial is to learn about the safety and tolerability of GO321 recombinant oncolytic virus injection, and if GO321 recombinant oncolytic virus injection works to treat advanced solid tumors in adults whose cancers have progressed after standard-of-care therapy. It will also learn about the pharmacokinetic features, viral shedding, immunogenicity of GO321, immune markers, and genomic and proteomic changes in patients. The main questions it aims to answer are: What safety issues and tolerability limitations do participants experience when receiving GO321 via intratumoral or intracavitary injection? Does GO321 have preliminary anti-tumor efficacy against advanced solid tumors resistant to standard treatment? What changes take place in viral distribution, viral shedding, immunity, blood immune markers, tumor or blood genomics and proteomics after GO321 administration? Researchers will assess different doses and dosing schedules of GO321 given by intratumoral or intracavitary injection across two study phases to find a suitable administration dose and regimen and verify the study endpoints.
Participants will:
Receive either a single injection of GO321 at different dose levels (in Part 1) or repeated GO321 injections at the recommended Phase 2 dose (in Part 2) by intratumoral or intracavitary routes; Complete scheduled hospital visits to undergo laboratory tests, imaging examinations and biological sample collection; Have their safety indicators, anti-tumor response, viral parameters, immune indicators and molecular profiles tracked throughout the study.
Detailed description
This study adopts a single-arm, open-label, dose-escalation design to investigate the safety, tolerability, and preliminary efficacy of GO321 recombinant oncolytic virus injection via intratumoral or intracavitary administration in patients with advanced solid tumors progressing after standard-of-care (SOC) therapy. The trial consists of two parts: a single-dose escalation phase and a multiple-dose expansion phase.
Part 1: Single-Dose Escalation The primary Objectives: To evaluate the safety and tolerability of single intratumoral or intracavitary GO321 injection at varying dose levels in SOC-refractory advanced solid tumor patients, and identify the Recommended Dose (RD) of intratumoral/intracavitary administration for Phase 2..
The secondary Objectives: 1) To evaluate the pharmacokinetic (PK) profile and viral shedding of GO321 following single intratumoral/intracavitary administration; 2) To evaluate the preliminary efficacy of GO321; 3) To evaluate the immunogenicity of GO321; 4) To monitor peripheral blood pharmacodynamic immunological markers related to T-lymphocyte subsets and changes in plasma cytokines (as applicable).
The exploratory Objectives: To assess changes in genomic or proteomic profiles in tumor tissue or peripheral blood (as applicable).
Part 2: Multiple-Dose Expansion The Main Objectives is to evaluate the safety and tolerability of multiple intratumoral (or intracavitary) injections of GO321 at the RD level in SOC-refractory advanced solid tumor patients, and determine the optimal dosing regimen.
The secondary Objectives: 1) To evaluate the pharmacokinetic (PK) profile and viral shedding of GO321 following multiple intratumoral/intracavitary administrations; 2) To evaluate the preliminary efficacy of GO321; 3) To evaluate the immunogenicity of GO321; 4) To monitor peripheral blood pharmacodynamic immunological markers related to T-lymphocyte subsets and changes in plasma cytokines (as applicable).
The exploratory Objectives: To assess changes in genomic or proteomic profiles in tumor tissue or peripheral blood (as applicable).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, non-randomized study which comprises two parts: * Part 1: A 3+3 single-dose escalation phase to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicities (DLTs), and Recommended Dose (RD) of the investigational product. * Part 2: A multiple-dose expansion phase at the RP2D level to explore preliminary efficacy in specific tumor types.
| Arm | Type | Receives |
|---|---|---|
| GO321 Treatment | Experimental | Drug: GO321This is a single-arm, non-randomized study which comprises two parts: - Part 1: A 3+3 single-dose escalation phase to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicities (DLTs), and Recommended Dose (RD) of the investigational product. - Part 2: A multiple-dose expansion phase at the RD level to explore preliminary efficacy in specific tumor types. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 years old and above, regardless of gender.
- Histologically or cytologically confirmed advanced malignant solid tumors that are refractory to or have failed standard therapy (including disease progression and/or intolerance to toxicity), or for which no standard therapy is available.
- For patients with malignant ascites secondary to malignant tumors (e.g., ovarian cancer, gastrointestinal solid malignancies) who are planned to receive intracavitary injection, the following criteria must be met:
- Patients scheduled for intratumoral injection must meet the following requirements: At least one evaluable lesion confirmed by local imaging per RECIST v1.1 that is amenable to intratumoral injection. A lesion suitable for intratumoral injection (with or without CT/ultrasound guidance) is defined as a palpable mass or a mass visible by CT/ultrasound that can be injected under CT/ultrasound guidance, located in the skin, subcutaneous tissue, or deep-seated regions, with a longest diameter ≥ 1.0 cm (or short axis ≥ 1.5 cm if a lymph node), and deemed appropriate for intratumoral injection by the investigator. If the injection site has been previously irradiated, eligibility may be considered after discussion with the sponsor.
- Eastern Cooperative Oncology Group (ECOG) score ≤2.
Key exclusion criteria (32 listed)
- Female participants who were pregnant or lactating.
- Presence of another malignancy within the previous 2 years, except for cancers with a low risk of metastasis and death (5-year survival rate, >90%), such as adequately treated basal-cell or squamous-cell skin cancer or carcinoma in situ of the cervix and other cancers in situ.
- Adverse events from prior anti-tumor therapy have not recovered to Grade ≤ 1 per CTCAE v6.0, or to the levels specified in the inclusion/exclusion criteria (with the exception of alopecia, skin hyperpigmentation, or other toxicities deemed by the investigator to have no safety risk). Participants with chronic Grade 2 toxicity may be eligible after discussion with the sponsor, provided the toxicity is asymptomatic or adequately controlled with stable medications.
- Received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product; received oral fluoropyrimidines or small-molecule targeted agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose; received traditional Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose; received other systemic anti-tumor therapies, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose.
- Presence of any of the following infections or diseases:
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 |
|---|---|---|
| GO321Part 1: 3+3 Single-Dose Escalation Phase： This phase adopts a standard 3+3 dose-escalation design. GO321 is administered via intratumoral or intracavitary single injection, with the dose escalating progressively within the range of 3.0E+07 PFU to 1.0E+09 PFU. Each dose cohort will enroll 3 subjects, and all enrolled subjects will receive a single initial administration of the study drug. Part 2: Multiple-Dose Expansion Phase： This expansion phase is conducted at the recommended dose (RD) level, aiming to explore the preliminary anti-tumor efficacy of GO321 in specific tumor types. A total of 9 subjects with specific tumor types will be enrolled in this cohort. GO321 is administered via intratumoral or intracavitary injection on a once-weekly (QW) or once-every-two-weeks (Q2W) dosing schedule. | Drug | GO321 Treatment |
Primary outcome
AEs
Time frame: Up to 6 months after the last GO321 administration
Adverse events (AEs) will be graded according to the CTCAE Version 6.0 published by the U.S. National Cancer Institute.
SAEs
Time frame: Up to 6 months after the last GO321 administration.
Serious Adverse events (SAEs) will be graded according to the CTCAE Version 6.0 published by the U.S. National Cancer Institute.
DLT
Time frame: within 28 days after the first GO321 administration.
The Dose-Limiting Toxicities (DLTs) assessed using the NCI CTCAE v6.0.
RD
Time frame: Through study of Part 1 completion, an average of 9 months.
The Recommended Dose (RD) will be determined based on the integrated analysis of Part 1 (3+3 dose-escalation phase) results.
8 secondary outcomes
Pharmacokinetics/Viral Shedding
Time frame: Within 28 Days after the last GO321 administration
ORR
Time frame: Up to 5 years after the last GO321 administration.
DCR
Time frame: Up to 5 years after the last GO321 administration.
PFS
Time frame: Up to 5 years after the last GO321 administration.
DOR
Time frame: Up to 5 years after the last GO321 administration.
OS
Time frame: Up to 5 years after the last GO321 administration.
Pharmacodynamics/Immunological Markers
Time frame: Within 28 days after the last GO321 administration
Immunogenicity indicators
Time frame: Within 28 days after the last GO321 administration.
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 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor Malignancies
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
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 GO321 in people with Solid Tumor Malignancies, run by GeneSail Biotech (Shanghai) 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 32 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 5 Aug 2026. 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 Ning Li, Doctor (010-67781331, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (time frame: Up to 6 months after the last GO321 administration). The study lists 4 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 5 Aug 2026.