Hepato Cellular Carcinoma (HCC)Phase 2NCT07494435
Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With HCC and RCC
A Phase 2 study testing WGI-0301 and Nivolumab (240 mg) in people with Hepato Cellular Carcinoma (HCC) and Renal Cell Cancer, run by Zhejiang Haichang Biotech Co., Ltd. at 1 site in China.
Trial summary
This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with nivolumab, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepato Cellular Carcinoma (HCC), Renal Cell Cancer
- What is being tested?
- WGI-0301 and Nivolumab (240 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Sep 2028
- Phase
- Phase 2
- 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
- 1) Age 18-75 (inclusive) on the day of singing informed consent, male or female.
- 2) Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol 3) Subjects in each disease cohorts will need to fulfill the following criteria:
- HCC Cohort:
- Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria
- 4. Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not suitable for any curative surgeries or locoregional therapy
- Child-Pugh Liver Function Class A or Class B (score ≤ 7)
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- Documented first-line standard treatment failure (disease progression or intolerance)；
- nccRCC Cohort：Histologically or cytologically confirmed diagnosis of nccRCC，that is locally advanced or with distant metastasis, and have not received any prior systemic antitumor therapy. If disease progression occurs within 6 months after the last dose of adjuvant therapy, it is considered a failure of first-line treatment and thus does not meet the criteria.
- ccRCC Cohort：Histologically or cytologically confirmed ccRCC, with locally advanced unresectable disease or distant metastasis, and disease progression or intolerance after prior first-line therapy. Patients who have received adjuvant or neoadjuvant therapy may also be screened if they meet the above criteria.
- 4) Eligible for treatment with Nivolumab as determined by investigators according to the Package Insert and clinical judgment.
- 5) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 7 days prior to the first dose of study intervention 6) Life expectancy in the judgement of the Investigator > 12 weeks. 7) Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy such as radiotherapy; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.
- 8) Any adverse events (AEs) related to prior anti-tumor therapy must have resolved to ≤ Grade 1 (CTCAE v6.0). However, patients may still be screened if the investigator determines that the toxicity is well-controlled and does not affect the patient's safety or compliance with the study drug, and this has been confirmed with the sponsor.
- 9) Collection of an archived tissue sample will be requested (where available) or agree to undergo tumor tissue biopsy for biomarker testing; however, a subject will not be precluded from participating in the study if tissue sample is not available for collection or is otherwise insufficient for analysis.
- 10) Patients must have adequate organ function as defined below:
- For patients with no liver metastasis or lesion: AST and ALT ≤2.0× ULN, and total bilirubin ≤1.5×ULN; For patients with liver metastasis or lesion: AST and ALT ≤3.0× ULN, and total bilirubin ≤2×ULN; For patients with Gilbert Syndrome: Total bilirubin ≤3×ULN
- Serum albumin≥30g/L
- Creatinine Clearance (CrCL) ≥50 mL/min (Cockcroft-Gault formula: Ccr=(140-Age)×body weight (Kg)/72×Scr（mg/dl）{×0.85 for female subject}
- International Normalized Ratio (INR) ≤2.0 (except for patients on warfarin therapy)
- Hemeglobin≥90g/L, ANC ≥1.5×10^9/L, platelet count≥75×10^9/L (no blood transfusion, blood products, cell growth factors, albumin or any other corrective therapeutic drugs within 14 days) 11) Participants with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection will be allowed if they meet the following criteria:
- HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA < 500 IU/ mL, and should be managed according to treatment guidelines. Those on antiviral therapy at screening should have been treated for >2 weeks before the first dose
- HCV-HCC: • HCV-HCC: Resolved HCV infection (as evidenced by detectable HCV RNA or antibody), or stable HCV infection (such as normal LFTs or being asymptomatic). Patients with positive HCV RNA requiring direct antiviral agent treatment, or those with HBV and HCV co-infection are excluded 12) Women of child-bearing potential (WOCBP) must have a negative serum pregnancy within 3 days prior to receiving the first dose of study medication and must use accepted highly effective methods of contraception from the time of signing the informed consent through 6 months after the last dose of study drug. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, or be surgically sterile, for the duration of study participation, and for 3 months after completion of study drug administration.
Who cannot join
- 1) Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study 2) For the HCC Cohort, any of the following criteria：
- Locoregional therapy to liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).
- Fibrolamellar carcinoma, sarcomatoid hepatocellular carcinoma or mixed hepatocellular cholangiocarcinoma；
- 3. Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein) 3) Major surgery within 4 weeks prior to the first dose of study intervention. 4) Currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention (except for observational clinical trials) 5) Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose 6) Received systemic corticosteroid (prednisone >10mg/day or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of study intervention. Inhale or local corticosteroid, or pre-medications for infusion-related reactions/ hypersensitivity is allowed.
- 7) Received live vaccines and live attenuated vaccines within 4 weeks prior to the first dose of study treatment, or expected to received live vaccinve or live attenuated vaccine while participating in the study 8) Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs, or Nivolumab or related excipients 9) Prior treatment with agents targeting the PI3K-AKT pathway 10) 13. Clinically significant cardiovascular disease including:
- Uncontrolled chronic hypertension defined as systolic > 150 mmHg or diastolic > 90 mmHg on more than one measurement despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings prior to enrollment is < 150/ 90 mmHg)
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- Hypotension as indicated by systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg on 2 consecutive measurements at the Screening Visit
- NYHA class III or IV Congestive heart failure, stroke, transient ischemic attack, pulmonary embolism, myocardial infarction, unstable angina pectoris, or left ventricular ejection fraction < 50% within 6 months prior to the first dose.
- Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy)
- Bradycardia (known history of cardiovascular disease and either physical examination at rest or electrocardiogram indicating heart rate < 50 bpm), or screening ECG indicating QTcF > 470 msec, 2 retests are required for the first abnormal QTcF , and the mean value should be taken from the 3 readings. Or there is severe arrhythmia requiring further treatment, including but not limited to ventricular fibrillation, atrial fibrillation, sustained ventricular tachycardia, second-degree or third-degree atrioventricular block, torsades de pointes, etc.
- 11) Clinically significant bleeding risks including:
- Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hereditary hemorrhagic telangiectasia or von Willebrand disease)
- History of bleeding symptoms due to esophageal or gastric varices within 6 months prior to the first dose
- Received thrombolytic agents within 10 days prior to the first dose, or currently receiving anticoagulant therapy (e.g. anticoagulant, antiplatelet) and subject 's INR and APTT are not within expected therapeutic range of anticoagulant (except sodium heparin for maintenance of central venous catheter patency) 12) Known HIV or AIDS related illness, or history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant 13) Patients with endocrine disorders that cannot be effectively controlled by hormone replacement therapy 14) Presence of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, including but not limited to: systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, etc. However, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency managed with hormone replacement therapy only; skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia); or conditions not expected to recur in the absence of external triggers are allowed.
- 15) History of gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula, or abdominal abscess within 6 months prior to the first dose 16) Skin ulcers or severe, non-healing, or dehisced wounds within 3 months prior to the first dose 17) Known active or uncontrolled infection that may interfere with the study (e.g., active infection requiring intravenous antibiotic therapy or unexplained fever >38.5°C) 18) History of interstitial lung disease or prior non-infectious pneumonitis requiring corticosteroid treatment, or imaging findings suggestive of active pneumonia 19) History of other malignancies prior to or at study entry (except for adequately treated carcinoma in situ of the cervix, basal cell and squamous cell skin cancer, or other malignancies that have undergone curative treatment with no evidence of disease for at least 3 years).
- 20) Pleural effusion, ascites, or pericardial effusion that are clinically symptomatic or requiring repeated drainage (as judged by the investigator) 21) Known symptomatic or untreated brain metastases, leptomeningeal metastases, or other central nervous system metastases (except for asymptomatic cases not requiring treatment).
- 22) History of drug abuse or addiction 23) Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data
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
China Pharmaceutical University, Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, 200131
About this study
Official title: An Open-Label Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma or Advance Renal Cell Carcinoma
This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with nivolumab, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer or advanced kidney cancer.
- Conditions
- Hepato Cellular Carcinoma (HCC), Renal Cell Cancer
- Being tested
- WGI-0301, Nivolumab (240 mg)
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGI-0301Drug
WGI-0301 at Maximum Tolerated Dose (MTD)
Nivolumab (240 mg)Drug
Nivolumab is given as an intravenous infusion, every 2 weeks
WGI-0301Drug
WGI-0301 at dose level below Maximum Tolerated Dose (MTD-1)
| Study group | Role | What they receive |
|---|---|---|
| HCC High Dose | Experimental | Not described Receives: Drug: WGI-0301; Drug: Nivolumab (240 mg) |
| HCC Low Dose | Experimental | Not described Receives: Drug: Nivolumab (240 mg); Drug: WGI-0301 |
| ccRCC High Dose | Experimental | Not described Receives: Drug: WGI-0301; Drug: Nivolumab (240 mg) |
| ccRCC Low Dose | Experimental | Not described Receives: Drug: Nivolumab (240 mg); Drug: WGI-0301 |
| nccRCC High Dose | Experimental | Not described Receives: Drug: WGI-0301; Drug: Nivolumab (240 mg) |
| nccRCC Low Dose | Experimental | Not described Receives: Drug: Nivolumab (240 mg); Drug: WGI-0301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of WGI-0301 in Combination with Nivolumab
Efficacy will be assessed via Objective Response Rate (ORR), as determined by investigator using RECIST 1.1.
Measured: 24 months
Secondary outcomes (7)
Safety and tolerability of WGI-0301 in combination with Nivolumab
Determined by number of AEs, SAEs
Measured: 24 months
Peak Plasma Concentration (Cmax)
Drug Concentration in the boold will be used to determine Peak Plasma Concentration (Cmax)
Measured: 7 months maximum
Tmax (Time to peak drug concentration)
Drug Concentration in the boold will be used to determine Tmax (Time to peak drug concentration)
Measured: 7 months maximum
Area under the Curve (AUC)
Drug Concentration in the boold will be used to determine Area under the Curve (AUC)
Measured: 7 months maximum
Disease Control Rate (DCR)
Percentage of Patients with Partial Response (PR) or Stable Disease (SD) at the end of treatment
Measured: 24 months
Progression-Free Survival (PFS)
The duration from randomization to disease progression
Measured: 24 months
Overall Survival (OS)
The duration from randomization to death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular Carcinoma (HCC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Haichang Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494435
- Sponsor's protocol ID
- WGI0301-P2G-02
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma or Advance Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07494435
- Acronym / sponsor ID
- WGI0301-P2G-02
- Conditions
- Hepato Cellular Carcinoma (HCC), Renal Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Zhejiang Haichang Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 27 Mar 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.
This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with nivolumab, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer or advanced kidney cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HCC High Dose | Experimental | Drug: WGI-0301, Drug: Nivolumab (240 mg) |
| HCC Low Dose | Experimental | Drug: Nivolumab (240 mg), Drug: WGI-0301 |
| ccRCC High Dose | Experimental | Drug: WGI-0301, Drug: Nivolumab (240 mg) |
| ccRCC Low Dose | Experimental | Drug: Nivolumab (240 mg), Drug: WGI-0301 |
| nccRCC High Dose | Experimental | Drug: WGI-0301, Drug: Nivolumab (240 mg) |
| nccRCC Low Dose | Experimental | Drug: Nivolumab (240 mg), Drug: WGI-0301 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 1) Age 18-75 (inclusive) on the day of singing informed consent, male or female.
- 2) Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol 3) Subjects in each disease cohorts will need to fulfill the following criteria:
- 4) Eligible for treatment with Nivolumab as determined by investigators according to the Package Insert and clinical judgment.
- 5) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 7 days prior to the first dose of study intervention 6) Life expectancy in the judgement of the Investigator > 12 weeks. 7) Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy such as radiotherapy; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.
- 8) Any adverse events (AEs) related to prior anti-tumor therapy must have resolved to ≤ Grade 1 (CTCAE v6.0). However, patients may still be screened if the investigator determines that the toxicity is well-controlled and does not affect the patient's safety or compliance with the study drug, and this has been confirmed with the sponsor.
Key exclusion criteria (17 listed)
- 1) Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study 2) For the HCC Cohort, any of the following criteria：
- 7) Received live vaccines and live attenuated vaccines within 4 weeks prior to the first dose of study treatment, or expected to received live vaccinve or live attenuated vaccine while participating in the study 8) Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs, or Nivolumab or related excipients 9) Prior treatment with agents targeting the PI3K-AKT pathway 10) 13. Clinically significant cardiovascular disease including:
- 15) History of gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula, or abdominal abscess within 6 months prior to the first dose 16) Skin ulcers or severe, non-healing, or dehisced wounds within 3 months prior to the first dose 17) Known active or uncontrolled infection that may interfere with the study (e.g., active infection requiring intravenous antibiotic therapy or unexplained fever >38.5°C) 18) History of interstitial lung disease or prior non-infectious pneumonitis requiring corticosteroid treatment, or imaging findings suggestive of active pneumonia 19) History of other malignancies prior to or at study entry (except for adequately treated carcinoma in situ of the cervix, basal cell and squamous cell skin cancer, or other malignancies that have undergone curative treatment with no evidence of disease for at least 3 years).
- 20) Pleural effusion, ascites, or pericardial effusion that are clinically symptomatic or requiring repeated drainage (as judged by the investigator) 21) Known symptomatic or untreated brain metastases, leptomeningeal metastases, or other central nervous system metastases (except for asymptomatic cases not requiring treatment).
- 22) History of drug abuse or addiction 23) Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data
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 |
|---|---|---|
| WGI-0301WGI-0301 at Maximum Tolerated Dose (MTD) | Drug | HCC High Dose, ccRCC High Dose, nccRCC High Dose |
| Nivolumab (240 mg)Nivolumab is given as an intravenous infusion, every 2 weeks | Drug | HCC High Dose, HCC Low Dose, ccRCC High Dose, ccRCC Low Dose, nccRCC High Dose, nccRCC Low Dose |
| WGI-0301WGI-0301 at dose level below Maximum Tolerated Dose (MTD-1) | Drug | HCC Low Dose, ccRCC Low Dose, nccRCC Low Dose |
Primary outcome
Efficacy of WGI-0301 in Combination with Nivolumab
Time frame: 24 months
Efficacy will be assessed via Objective Response Rate (ORR), as determined by investigator using RECIST 1.1.
7 secondary outcomes
Safety and tolerability of WGI-0301 in combination with Nivolumab
Time frame: 24 months
Peak Plasma Concentration (Cmax)
Time frame: 7 months maximum
Tmax (Time to peak drug concentration)
Time frame: 7 months maximum
Area under the Curve (AUC)
Time frame: 7 months maximum
Disease Control Rate (DCR)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
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 27 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WGI-0301 and Nivolumab (240 mg) in people with Hepato Cellular Carcinoma (HCC) and Renal Cell Cancer, run by Zhejiang Haichang Biotech 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 21 inclusion and 17 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 27 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Angela Men (240-702-0080, angela.men@thewogroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of WGI-0301 in Combination with Nivolumab (time frame: 24 months). 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 27 Mar 2026.