Malignancies Including Melanoma, Kidney, Lung, Colorectal, Prostate, Neuroendocrine TumorPhase 1NCT02464007
Study of rSIFN-co for Patients With Advanced Solid Tumors
A Phase 1 study testing rSIFN-co in people with Malignancies Including Melanoma, Kidney, Lung, Colorectal, Prostate, Neuroendocrine Tumor, run by Sichuan Huiyang Life Science and Technology Corporation at 4 sites in United States.
Trial summary
In this EffTox dose escalation study, up to 3 dose levels will be tested. The optimal dose (OD) of rSIFN-co will be determined using the EffTox design. Additional subject cohorts will not be enrolled until all subjects at the current dose level complete 28 days without DLT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignancies Including Melanoma, Kidney, Lung, Colorectal, Prostate, Neuroendocrine Tumor
- What is being tested?
- rSIFN-co
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Diagnosis of advanced solid tumors limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor progressing on standard therapy.
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1.
- Prior systemic chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery for resection of solid tumor (limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor) are allowed.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Has adequate hepatic function defined as total bilirubin ≤1.5 mg/dL, unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin or ≤ 2 ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 x ULN for subjects with known hepatic metastases.
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- Has adequate renal function defined as serum creatinine or ≤ 1.5 × ULN and creatinine clearance or ≥ 40 ml/min.
- Has adequate bone marrow function defined as a hemoglobin > 9 g/dL, absolute neutrophil count (ANC) ≥1.5 ×10⁹/L , and platelet count ≥100,000/mm³. For subjects who received chemotherapy for melanoma just prior to screening for the study subject needs to have a hemoglobin > 9 g/dL, absolute neutrophil count (ANC) >2 × 10⁹/L, and platelet count ≥100,000/mm³.
- Must be willing and able to comply with study visits and procedures.
- Has read, understood and signed the informed consent form (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
- Women of childbearing potential (WOCP) must not be pregnant (confirmed by a negative pregnancy test, with a serum beta-HCG with a sensitivity of 50 mIU/ml within 7 days of study treatment) or breast-feeding. In addition, a medically acceptable method of birth control must be used such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study and at least one month after the last dose of study drug. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
- Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the date of the first dose of study drug through at least one month after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
Who cannot join
- Chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery within 4 weeks prior to first dose of study drug.
- Prior mTOR inhibitor therapy within 4 weeks prior to first dose of study drug.
- Has a history of autoimmune disorders, including uncontrolled diabetes ("uncontrolled" defined as Hemoglobin A1c ≥ 9% in 28 days prior to study).
- Chronic use of steroid therapy.
- Has a history of epilepsy, depression or other psychiatric disorders.
- Has a history of an arterial thromboembolic event within the prior six months including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina.
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- Has uncontrolled human immunodeficiency virus (HIV) (defined as HIV RNA >500 copies/ml and CD4+ count<200/mm³ on antiretroviral therapy)infection, or hepatitis B (defined as ALT > 1 x ULN, and HBV DNA >2000 IU/ml), or hepatitis C (defined as ALT > 1 x ULN, persistent viremia on antiviral therapy) infections.
- Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment (patient must be on stable dose for 2 weeks).
- Prior allogeneic bone marrow or organ transplantation.
- Has any clinically significant infection, i.e., any acute viral, bacterial, or fungal infection that requires specific treatment (anti-infective treatment has to be completed ≥ 7 days prior to study entry).
- Has any other severe, uncontrolled medical condition, including unstable congestive heart failure (Stage III-IV of the New York Heart Association Functional Classification) or has a known or suspected allergy to the study drug or any study drug component.
- Pregnant or breastfeeding - interferon products (e.g., Infergen®) is Pregnancy Category C, (i.e., animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans.). Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Subject has received other investigational drugs within 14 days prior to first dose of study drug.
- Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for enrollment in this study.
- Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant or baseline prolongation of the rate-corrected QT interval (e.g., repeated demonstration of QTc interval > 480 milliseconds).
- Presence of any non-healing wound, fracture, or ulcer within 28 days prior to the first dose of study drug.
- Has any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.
- Has any mental or medical condition that prevents the subject from giving informed consent or participating in the trial
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois, Chicago
Chicago, Illinois, 60612
Mayo Clinic
Phoenix, Arizona, 85054
HealthPartners Institute
Saint Paul, Minnesota, 55101
About this study
Official title: A Phase 1 Study of rSIFN-co for Subjects With Advanced Solid Tumors Where Interferons Are Known to Have Demonstrated Antitumor Activity
In this EffTox dose escalation study, up to 3 dose levels will be tested. The optimal dose (OD) of rSIFN-co will be determined using the EffTox design. Additional subject cohorts will not be enrolled until all subjects at the current dose level complete 28 days without DLT. The optimal dose (OD) will be determined by evaluation of safety in each cohort and disease response by RECIST 1.1 at 8 weeks. Once the OD is determined, enrollment will continue until at least 9 subjects total are accrued at the OD. Pharmacokinetics of rSIFN-co will be conducted for all tested dose levels to characterize dose proportionality.
Read the detailed description
The initial cohort will be 3 subjects. Escalation to the next dose will continue unless a subject experiences a DLT, at which time a cohort will be expanded to up to 6 subjects. Provided there is only one DLT in that cohort, the dose will be escalated. However, if there are 2 DLTs in that cohort of up to 6 subjects, previous dose level will be expanded to total of 9 subjects.
If none of the dose levels are acceptable at study completion (i.e., >33% of subjects experiencing a DLT), an OD will not be identified, and the drug does not warrant further investigation.
- Being tested
- rSIFN-co
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rSIFN-coBiological
Artificial recombinant super-compound interferon (rSIFN-co) is a product of patented technological research made possible through protein modulation by spatial conformation control technology, and was developed by Sichuan Huiyang Life Science and Technology Corporation.
| Study group | Role | What they receive |
|---|---|---|
| sSIFN-co | Experimental | Dose escalation of rSIFN-co Receives: Biological: rSIFN-co |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionNov 2024
- Study completionNov 2024
Why it stopped: Protocol has been amended and the Protocol amendment of Phase II was approved by the US FDA on Nov 2024 through SN0028.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignancies Including Melanoma, Kidney, Lung, Colorectal, Prostate, Neuroendocrine TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyang Life Science and Technology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Responsible party
- Sponsor
- Investigators
- Guangwen Wei, Study director, Superlab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464007
- Sponsor's protocol ID
- STM-04
- Status last verified
- Apr 2024
- First submitted
- 3 Jun 2015
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This has not been determined.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of rSIFN-co for Subjects With Advanced Solid Tumors Where Interferons Are Known to Have Demonstrated Antitumor Activity
- ClinicalTrials.gov ID
- NCT02464007
- Acronym / sponsor ID
- STM-04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol has been amended and the Protocol amendment of Phase II was approved by the US FDA on Nov 2024 through SN0028.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sichuan Huiyang Life Science and Technology CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2024 (actual)
- Study completion
- Nov 2024 (actual)
- First posted
- 8 Jun 2015 (estimated)
- 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.
In this EffTox dose escalation study, up to 3 dose levels will be tested. The optimal dose (OD) of rSIFN-co will be determined using the EffTox design. Additional subject cohorts will not be enrolled until all subjects at the current dose level complete 28 days without DLT. The optimal dose (OD) will be determined by evaluation of safety in each cohort and disease response by RECIST 1.1 at 8 weeks. Once the OD is determined, enrollment will continue until at least 9 subjects total are accrued at the OD. Pharmacokinetics of rSIFN-co will be conducted for all tested dose levels to characterize dose proportionality.
Detailed description
The initial cohort will be 3 subjects. Escalation to the next dose will continue unless a subject experiences a DLT, at which time a cohort will be expanded to up to 6 subjects. Provided there is only one DLT in that cohort, the dose will be escalated. However, if there are 2 DLTs in that cohort of up to 6 subjects, previous dose level will be expanded to total of 9 subjects.
If none of the dose levels are acceptable at study completion (i.e., >33% of subjects experiencing a DLT), an OD will not be identified, and the drug does not warrant further investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sSIFN-co | Experimental | Biological: rSIFN-coDose escalation of rSIFN-co |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female ≥ 18 years of age
- Diagnosis of advanced solid tumors limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor progressing on standard therapy.
- Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1.
- Prior systemic chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery for resection of solid tumor (limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor) are allowed.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
Key exclusion criteria (18 listed)
- Chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery within 4 weeks prior to first dose of study drug.
- Prior mTOR inhibitor therapy within 4 weeks prior to first dose of study drug.
- Has a history of autoimmune disorders, including uncontrolled diabetes ("uncontrolled" defined as Hemoglobin A1c ≥ 9% in 28 days prior to study).
- Chronic use of steroid therapy.
- Has a history of epilepsy, depression or other psychiatric disorders.
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 |
|---|---|---|
| rSIFN-coArtificial recombinant super-compound interferon (rSIFN-co) is a product of patented technological research made possible through protein modulation by spatial conformation control technology, and was developed by Sichuan Huiyang Life Science and Technology Corporation. | Biological | sSIFN-co |
Primary outcome
Maximum Tolerated Dose
Time frame: 28-days
Results and safety
The study was stopped early (reason given: Protocol has been amended and the Protocol amendment of Phase II was approved by the US FDA on Nov 2024 through SN0028.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided. This has not been determined.
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. This study is not recruiting at the moment.
Guangwen Wei study director
Superlab
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rSIFN-co in people with Malignancies Including Melanoma, Kidney, Lung, Colorectal, Prostate, Neuroendocrine Tumor, run by Sichuan Huiyang Life Science and Technology Corporation at 4 sites in United States.
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 12 inclusion and 18 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: stopped early, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Protocol has been amended and the Protocol amendment of Phase II was approved by the US FDA on Nov 2024 through SN0028.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 28-days). 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 25 Feb 2025.