Actively Recruiting
An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Led by Virogin Biotech Canada Ltd · Updated on 2024-08-09
97
Participants Needed
3
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Safety Run-in Cohort (cohort 1): 10 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days. Monotherapy Cohorts (Cohort 2 and 3) Cohort 2 (HCC) This part is a single-agent, single one-dose level and single-arm design. Approximately 39 subjects will be enrolled in the study to receive VG161. In the first stage, 21 subjects will be enrolled. If there is only 1 or fewer subjects has been observed with objective response and no more than 12 (\<13) subjects have PFS longer than 3 months, the trial will be stopped. Otherwise, this study will continue to enter the second stage, and 18 additional subjects will be added, and the total number of trial subjects will reach 39. Cohort 3 (ICC) This part is a single-agent, single one-dose level and single-arm design. The trial will be carried out in two periods. In the first period, a total of 20 subjects will be enrolled. If there is only 1 or fewer response case in the 20 subjects, the trial will be stopped to investigate the efficacy of the IP, otherwise, subjects will continue to enter the second period, and 13 additional subjects will be added, and the total number of trial cases will reach 33. Cohort 4 (ICC and HCC) Combination with Nivolumab Combination cohort and subjects will receive VG161 at the same schedule as the monotherapy cohorts and 240 mg of intravenous Nivolumab on days 8 and 15 of each treatment cycle. The Nivolumab dose can be changed to 480 mg every 4 weeks after cycle one based on investigator's discretion.
CONDITIONS
Official Title
An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Male or female aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- For Cohort 2 (HCC): Cytologically confirmed advanced/metastatic or unresectable hepatocellular carcinoma with disease progression after at least two lines of FDA approved systemic therapy including immunotherapy or anti-angiogenesis therapy.
- For Cohort 3 (ICC): Histologically or cytologically confirmed advanced/metastatic or unresectable intrahepatic cholangiocarcinoma with disease progression after first-line chemotherapy; patients with IDH1 mutation must have received IDH1 inhibitor therapy and patients with MSI-H tumors must have received PD-1 inhibitor immunotherapy.
- For Cohorts 1 and 4: Must meet inclusion criteria for either Cohort 2 or Cohort 3.
- Liver function Child-Pugh A-B for Cohorts 1 and 2.
- At least one measurable lesion per RECIST 1.1 criteria.
- At least one injectable lesion 15 mm or larger in longest diameter, deemed injectable by investigator, including deep or visceral lesions safely injectable under imaging guidance.
You will not qualify if you...
- Participation in any other investigational agent trial within 4 weeks prior to dosing.
- Tumors located in mucosal regions or near airway, major blood vessel, or spinal cord that risk occlusion or compression.
- Any primary central nervous system malignancy or active, progressing CNS malignancy; treated brain metastases allowed if stable for at least 4 weeks and off steroids for 2 weeks.
- Major surgery within 14 days prior to dosing.
- Serious infections within 28 days prior to screening or systemic antibiotic treatment within 14 days prior to consent.
- Life-threatening illness unrelated to cancer.
- Active herpes infection or antiviral treatment within 14 days prior to dosing.
- Uncontrolled congestive heart failure.
- Known positive test for HIV or syphilis.
- Active hepatitis B or C infection under antiviral treatment affecting study drug.
- Use of ganciclovir or acyclovir within 14 days prior to dosing.
- Systemic corticosteroids (>10 mg prednisone equivalent daily) or other immunosuppressive medications within 14 days prior to dosing (except low-dose inhaled/topical steroids or adrenal replacement).
- Systemic anticoagulants within 14 days prior to dosing or INR >1.5 times upper limit.
- Prior radiation therapy to the tumor to be injected unless progression is documented on recent imaging.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
N
Naghmeh Esmaeili
CONTACT
M
Mike Teng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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