SynOV1.1 Intratumoral Injection Study

NCT04612504 | Unknown Phase 1

• 1 other identifier: Syngentech-SynOV1.1-101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

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

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

  30 months

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

  MTD for patients with HCC received SynOV1.1 treatment.

  30 months

• The response rate of patients with HCC receiving SynOV1.1

  response rate based on RECIST ver. 1.1

  30 months

Secondary Outcomes (3)

• The biodistribution of SynOV1.1，as determined by the concentration of SynOV1.1 in blood of participating patients.

  30 months

• The immunogenicity of SynOV1.1, as determined by quantitation of neutralizing antibodies in blood of participating patients.

  30 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  30 months

Study Arms (1)

SynOV1.1 Injection

EXPERIMENTAL

Biological: SynOV1.1

Interventions

SynOV1.1 BIOLOGICAL

SynOV1.1 will be administered intratumorally.

SynOV1.1 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A female participant who is postmenopausal, or whose serum pregnancy test result is negative. A woman who has not experienced a menstrual period for 12 months due to non-medical reasons is considered postmenopausal.
• Female participants of child-bearing potential and male participants shall agree to take medically acceptable contraception measures (hormones, barrier, or abstinence) while on treatment and for 90 days following completion of treatment.

You may not qualify if:

• 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.
• History of meningococcal disease.
• Evidence of uncontrolled severe comorbidity that may affect the participant's compliance with the study protocol, including severe liver disease (e.g. severe esophageal and gastric varices that require interventional treatment, cirrhosis, hepatic encephalopathy, or venous syndrome).
• History of serious cardiovascular disease。
• Participants who have third interstitial fluid beyond clinical control judged by the investigator.
• History of tuberculosis infection or immunodeficiency, including participants who have tested positive for the human immunodeficiency virus (HIV) antibody.

Sponsors & Collaborators

• Beijing Syngentech Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130012, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yanhua Ding, MD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ren, Bachelor

CONTACT

17390905515; y.ren@syngen.tech

Shuguang Peng, Master

CONTACT

86+18810456513; sg.peng@syngen.tech

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 3, 2020
• Study Start: June 23, 2022
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

CN (1)