A Study of rSIFN-co in Subjects With Advanced Solid Tumors

NCT02387307 | Completed Phase 1

• 1 other identifier: rSIFN-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via subcutaneous injection for 21 days, with 1 week of washout per cycle).

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Melanoma; Carcinoma, Hepatocellular; Colon Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse Events of rSIFN-co of recombinant interferon-α administered in solid Tumor

  Safety and tolerability will be determined after each cycle of treatment with SIFN-co of recombinant interferon-α, to patients via subcutaneous injection for 21 days (up to 6 cycles)

  Up to 12 weeks after the last treatment

• Recommended dose (RD) of rSIFN-co

  3+3 design for determination of RD. 4 doses (21µg, 24µg, 27µg and 30µg) are planned for determination of RD, dose escalation will be allowed till grade 3/4 toxicity is encountered in 2 or more of the 3 or 6 subjects in first cycle of treatment cycle

  Cycle 1 of treatment

Secondary Outcomes (6)

• Antitumor efficacy (Disease Control Rate), i.e. the percentage of patients, on the RD of rSIFN-co

  Up to 28 days after the last treatment

• Objective response rate (ORR), i.e. the percentage of patients, on rSIFN-co

  Up to 28 days after the last treatment

• Progression-free survival (PFS) time (days) on rSIFN-co

  Up to 28 days after the last treatment

• Time to progression (TTP) status (days) on rSIFN-co

  Up to 28 days after the last treatment

• FDG-PET response (lesion size) before and after administration of rSIFN-co

  Up to 28 days after the last treatment

Other Outcomes (3)

• Changes in subject cytokine profiles (pg/ml) before and after treatment

  Up to 28 days after the last treatment

• Evaluation of elected tumor repressive and enhancing genes (counts of genes such as microRNA-92a, microRNA-92b) before and after administration of rSIFN-co

  Up to 28 days after the last treatment

• Evaluation of levels (counts) of 2'5'-oligoadenylate synthetase, before and after administration of rSIFN-co

  Up to 28 days after the last treatment

Study Arms (1)

Cohort: Dose-Escalation and Expansion

EXPERIMENTAL

Dose-Escalation: Dose escalation in solid tumors utilizing a "3+3" design with intra-subject dose escalation. 4 dose levels of rSIFN-co are planned for determining the RD. Dose of rSIFN-co: 15, 21, 24, 27 and 30 ug. Dose-Expansion: The Expansion Cohort will be initiated at the RD. Depending on the RD, the lead in period will occur accordingly. After the lead in period, a period from Cycle 1 to the final administration will be performed as the Treatment Phase during which subjects will undergo a standardized evaluation for the safety and efficacy of rSIFN-co at the RD. Follow-up evaluations will be performed 28 days (±5 days) after the last rSIFN-co administration.

Drug: rSIFN-co

Interventions

rSIFN-co DRUG

rSIFN-co is a drug developed by Sichuan Huiyang Life Science and Technology Corporation for the treatment of solid tumors especially in non-small cell lung cancer and other tumor types. The study comprises of 2 stages: the dose-escalation stage and dose expansion stage.

Also known as: Recombinant-Compound Interferon (rSIFN-co)

Cohort: Dose-Escalation and Expansion

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a) Histologically confirmed diagnosis of advanced solid tumors that is metastatic or unresectable and for which standard therapies (according to local practice) or palliative measures do not exist or subject decides not to receive any available treatment (dose escalation cohort) OR
• b) Histologically or Cytologically diagnosis of Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma, Hepatocellular Carcinoma\* and Colon Cancer metastatic or unrespectable and for which standard therapies (according to local practice) or palliative measures do not exist or subject decides not to receive any available treatment (dose expansion cohort) (dose expansion cohort)
• \* Hepatocellular Carcinoma patients may be enrolled based on radiological diagnosis instead of histological or cytological diagnosis - based on "EASL-EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma (Journal of Hepatology 56:908-943, 2012), non-invasive hepatocellular carcinoma patients should not be put under additional undue risk of liver biopsy after the diagnosis of hepatocellular carcinoma has been ascertained with clinical, laboratory and radiographic evaluation."
• Measurable disease is preferred but not mandatory for the purpose of study accrual. Evaluable disease is sufficient.
• Age \> or = 21 years
• ECOG performance status \< or = 2
• Adequate laboratory values at the time of screening:
• (For both dose escalation and expansion)
• leukocytes ≥3,000/mcL
• absolute neutrophil count ≥1,500/mcL
• platelets ≥100,000/mcL
• haemoglobin ≥9.0 g/DL
• (Dose escalation only)
• total bilirubin ≤ the upper limits of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤ the upper limits of normal (ULN)

You may not qualify if:

• Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start of rSIFN-co administration or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Subjects receiving other investigational drugs within 5 times the half-life of the investigational drugs or within 4 weeks, prior to start of rSIFN-co administration.
• Subject must not have known untreated brain or meningeal metastases. CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease. Subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 4 weeks prior to start of rSIFN-co administration).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to interferon.
• Uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial pneumonia or psychiatric illness/social situations that would limit compliance with study requirements.
• HIV-positive subjects on combination antiretroviral therapy are ineligible because of the increased risk of lethal infections when treated with immunomodulatory therapy. Appropriate studies will be undertaken in subjects receiving combination antiretroviral therapy when indicated.
• The investigator or sub-investigator considers the subject's physique as inappropriate for investigational product treatment or any other reason(s) that may render the subjects inappropriate for participation in the trial.
• Subjects who may have autoimmune disorders, decompensated liver diseases or life-threatening neurologic diseases.

Sponsors & Collaborators

• Sichuan Huiyang Life Science and Technology Corporation: lead

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Melanoma; Carcinoma, Hepatocellular; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• David Wai Meng TAI

  National Cancer Center Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: March 13, 2015
• Study Start: July 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

SG (1)