An Open-label Phase I Study to Evaluate the Safety, Tolerability and Efficacy of SynOV1.1 Recombinant Oncolytic Adenovirus Injection as Monotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Beijing Syngentech Co., Ltd.1 site in 1 country15 target enrollmentJune 23, 2022

ConditionsHepatocellular Carcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Beijing Syngentech Co., Ltd.
Enrollment: 15
Locations: 1
Primary Endpoint: The response rate of patients with HCC receiving SynOV1.1
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I, open-label, multicenter study to characterize safety and tolerability, evaluate biodistribution, biological effects and immunogenicity, and evaluate the preliminary clinical efficacy of SynOV1.1 in participants with AFP positive solid tumors.

Detailed Description

Part 1 ( single dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. 3 dose level (3 × 10\^11 Vp, 1 × 10\^12 Vp, 3 × 10\^12 Vp) will be evaluated. Part 2 (multiple dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. Participants will receive administration bi weekly. 2 dose level will be evaluated based on part 1 result.

Registry

clinicaltrials.gov

Start Date

June 23, 2022

End Date

June 30, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Beijing Syngentech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily participates in the clinical trial study; fully understands the study and signs the ICF; and is willing to follow and will be able to complete all trial procedures.
•Is ≥18 years old when signing ICF; male or female.
•Has locally advanced or metastatic AFP-positive solid tumorsthat has relapsed or is refractory to standard cancer therapies, or where no standard therapies are available. AFP positive means that serum samples have levels of AFP\> 20 ng/ml during screening or an AFP immunohistochemistry \[IHC\] test of previous tumor tissue samples was positive.
•Has at least one lesion that cannot be surgically removed which can be injected directly or through ultrasound (US) and/or computer tomography (CT) guidance.
•Has at least one measurable tumor lesion.
•Has a Child-Pugh score of Class A.
•Has an ECOG performance status is 0 to 1 one week prior to the treatment.
•Has an expected survival time of ≥ 12 weeks.
•Has limited alterations in hematology or clinical chemistry: ANC≥ 1.5 × 10\^9/L, PLT≥ 75 × 109/L, TBIL≤ 1.5 ×ULN, AST and ALT≤5 × ULN, Alb≥ 2.8 g/dL, Crea≤ 1.5 × ULN, INR≤ 1.5 × ULN.
•Agrees to provide archived or fresh tumor tissue specimens according to the individual's situation and blood samples.

Exclusion Criteria

•Received any anti-tumor treatment within the 4 weeks prior to study drug administration. The anti-tumor treatment includes surgery, ethanol injection, radiofrequency ablation, trans-arterial chemoembolization, intrahepatic chemotherapy, chemotherapy, biotherapy, immunotherapy, hormone, or radiotherapy.
•Received a systemic treatment of glucocorticoid (Prednisone \> 10 mg/day or equivalent dose of a similar medicine) or other immunosuppressant treatment 14 days prior to study drug administration。
•Administration of immune-regulating medicines within 14 days prior to study drug administration of the investigational drug。
•Administration of live-attenuated vaccines within 4 weeks prior to study drug administration。
•Previously treated with oncolytic viruses or other gene therapies.
•Received treatment of unapproved investigational drugs within 4 weeks prior to study drug administration.
•Currently participating in another clinical study, except for an observational or genetic (non-interventional) clinical study or a follow-up period.
•Had major organ surgery (excluding biopsy) or had significant trauma within 4 weeks prior to study drug administration.
•An adverse event from the previous anti-tumor therapy that has not resolved to ≤ Grade 1 or stabilized according to NCI-CTCAE v5.0, except for the adverse event of non-risk toxicity as judged by the investigator and sponsor.
•Participants with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence demonstrating the central nervous system metastasis or meningeal metastasis has not been controlled.

Outcomes

Primary Outcomes

The response rate of patients with HCC receiving SynOV1.1

Time Frame: 30 months

response rate based on RECIST ver. 1.1

The dose-limiting toxicities (DLTs) of SynOV1.1 in patients with HCC

Time Frame: 30 months

Incidence and nature of DLT of SynOV1.1 in in patients with HCC, graded according to NCI CTCAE v5

The maximum-tolerated dose (MTD) of SynOV1.1 in patients with HCC

Time Frame: 30 months

MTD for patients with HCC received SynOV1.1 treatment.

Secondary Outcomes

The biodistribution of SynOV1.1，as determined by the concentration of SynOV1.1 in blood of participating patients.(30 months)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(30 months)
The immunogenicity of SynOV1.1, as determined by quantitation of neutralizing antibodies in blood of participating patients.(30 months)