Refractory Solid TumorPhase 1NCT03443622

Phase I Study of SC-43 Oral Solution in Subjects With Refractory Solid Tumors

A Phase 1 study testing SC-43 Oral Solution in people with Refractory Solid Tumor, run by SupremeCure Pharma Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Refractory Solid Tumor
What is being tested?: SC-43 Oral Solution
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: May 2021to Jun 2023
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 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Either gender, aged 20 to 75 years old (inclusive; the legal age of consent majority is 20 years old in Taiwan)
Life expectancy ≥ 12 weeks
With histologically or cytologically confirmed solid tumor(s) that is refractory to standard treatments, or for which a standard therapy is not available or is no longer effective
With at least one measurable target lesion as measured by MRI or CT according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
Subject who has received local therapies (such as surgery, radiation therapy, hepatic arterial embolization, or chemoembolization) is eligible. Local therapies must be completed at least 4 weeks prior to the baseline scan. However, the local therapy-treated tumor should be excluded for evaluation.
Eastern Cooperative Oncology Group (ECOG) performance status ≦2

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If female subject or female spouse/partner of male subject is of childbearing potential, she/he must agree to use highly effective contraceptives from signing informed consent to 28 days after the last dose of study drug administration.
At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
Established use of oral, injected or implanted hormonal methods of contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Dated and signed informed consent

Who cannot join

With primary central nervous system (CNS) malignancies or clinically active CNS metastases
The target solid tumor is lymphoma
Any of the following hematologic abnormalities:
Hemoglobin < 8.0 g/dL
Absolute neutrophil count (ANC) < 1,000/μL
Platelets < 80,000 /μL

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Any of the following serum chemistry abnormalities:
Total bilirubin > 1.5 × ULN
AST or ALT > 2.5 × ULN (> 5 × ULN in patients with HCC)
γ-GT > 2.5 × ULN (> 5 × ULN in patients with HCC)
ALP > 2.5 × ULN (> 5 × ULN in patients with HCC)
Serum albumin < 2.5 g/dL
Creatinine > 1.5 × ULN
aPTT >1.5 × ULN
INR >1.5 × ULN
Any other ≥ Grade 3 (according to CTCAE v.5.0) laboratory abnormality at baseline (other than those listed above) Note: ULN = upper limit of normal; AST = aspartate transaminase; ALT = alanine transaminase; γ-GT = Gamma-glutamyl transferase; ALP = alkaline phosphatase; aPTT = activated partial thromboplastin time; INR = international normalized ratio of prothrombin time
History of organ or tissue transplantation
History of autoimmune disease
Active clinically serious infection
History of human immunodeficiency virus (HIV) infection
Significant cardiovascular disease, including:
History of New York Heart Association (NYHA) class III or IV congestive heart failure
Ongoing uncontrolled hypertension
History of congenital long QT syndrome
Ongoing prolonged corrected QT (QTc) interval defined as ≥ 450 msec
History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
With ascertained hypersensitivity to any ingredient of the investigational product or drugs with similar chemical structures, including sorafenib. If there is suspicion that the subject may have an allergy, the subject should be excluded.
Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral SC-43 treatment
With significant gastrointestinal disorder(s) within 12 weeks prior to Screening that would, in the opinion of the investigator, prevent absorption of an orally available agent
Active bleeding during the last 4 weeks prior to Screening Visit
Requirement for ongoing immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine), or systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more than 14 days
Received an investigational agent within 4 weeks prior to Screening
Had previous anti-cancer therapy (surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, biology therapy, or hormonal therapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Screening Visit or has ongoing side effects (≥ Grade 2, according to CTCAE v.5.0) due to previously administered agents
Has undergone major surgery within 4 weeks before Screening Visit, or has elective or planned surgery to be conducted during the trial
Female with childbearing potential who has positive urine or serum pregnant test at Screening Visit or lactating
Is not considered to be suitable for this study, in the opinion of the investigator

About this study

Official title: Phase I Open-Label Dose-Escalating Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of SC-43 Oral Solution in Subjects With Refractory Solid Tumors

This phase I study will be conducted in an open-label, conventional 3+3 dose escalation design manner (for the first 28 days of dosing) followed by an extension period for subjects responsive to the study drug to continue dosing up to 52 weeks. This study is intended to assess the safety and efficacy of the investigational product (IP), SC-43 Oral Solution, in subjects with refractory solid tumors. Subjects who have diseases progressing unresponsive to the previous treatments or who have no standard treatments for their current diseases will be enrolled in this study once the eligibility is confirmed.

During the first 28 days, the study will be done in the conventional 3+3 design to determine the maximum tolerated dose (MTD) of SC-43 Oral Solution. The dose will be increased in a step-wise fashion from the initial dose of 100 mg/day to the dose of 200, 400, 600, 900, and 1200 mg/day. The pharmacokinetics (PK) of SC-43 will also be measured in this period.

The dose of SC-43 Oral Solution will be escalated to the subsequent cohorts when there is no dose-limiting toxicity (DLT) in 3 subjects or only one DLT in 6 subjects of the previous cohort, and it is recommended by Data and Safety Monitoring Board (DSMB). The safety results will be reviewed by DSMB after the last subject in the each cohort has finished the Visit 6 (Day 29), and DSMB will determine if it is safe to proceed to the next dose cohort.

Subjects who have finished the 28-day dose escalation period and with complete response (CR), partial response (PR), or stable disease (SD) will be eligible to enter the extension period and continue SC-43 Oral Solution therapy up to 52 weeks or until occurrence of unacceptable toxicity, withdrawn consent, disease progression, not receiving medical benefit as considered by investigators, loss of follow-up, or death, whichever comes first. For ethical and safety concerns, the dosage used in this extension period can be adjusted and different from the original dosage assignment. The actual dose of SC-43 Oral Solution, which must be confirmed safe, administered during this extension period will be at the investigator's discretion.

Read the detailed description

SC-43, has been shown to enhance the activity of Src homology region 2 domain-containing phosphatase-1 (SHP-1), leading suppression of STAT3 phosphorylation and tumor growth inhibition. SC-43 enhances SHP-1 activity by impairing the association between the N-SH2 domain and the PTP domain of SHP-1, triggering a conformational change of SHP-1 and relieving its autoinhibition. SC-43 treatment leads to cancer cell death in multiple cancer cell lines. SC-43 also exhibits anti-cancer activity in a variety of nonclinical xenograft tumor models.

Conditions: Refractory Solid Tumor
Being tested: SC-43 Oral Solution
Keywords: SC-43, refractory solid tumor, Phase I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SC-43 Oral SolutionDrug
SC-43 Oral Solution has drug substance of 1-[4-chloro-3(trifluoromethyl)phenyl-3-[3-(4-cyanophenoxy)] urea, or SC-43. SC-43 inhibits tumor growth through the activation of Src homology region 2 domain-containing phosphatase-1 (SHP-1) and the repression of p-STAT3 signalings. As a result of STAT3 inhibition by SC-43 treatment, decreased cell viability and enhanced apoptosis have been observed in cancer cells. The anti-tumor activity of SC-43 was also investigated in a variety of xenograft tumor models. Administration of SC-43 provides the tumor-bearing animals survival benefits, including the reduction of tumor volume and prolonged lifespan. SC-43 has been proposed to be evaluated as an anticancer therapeutic in in subjects with refractory solid tumors in the phase I trial.

Study groups in NCT03443622
Study group	Role	What they receive
SC-43 100 mg/day	Experimental	SC-43 Oral Solution (100 mg/ml), 1 ml by mouth, q.d. for 28 days Receives: Drug: SC-43 Oral Solution
SC-43 200 mg/day	Experimental	SC-43 Oral Solution (100 mg/ml), 2 ml by mouth, q.d. for 28 days Receives: Drug: SC-43 Oral Solution
SC-43 400 mg/day	Experimental	SC-43 Oral Solution (100 mg/ml), 4 ml by mouth, q.d. for 28 days Receives: Drug: SC-43 Oral Solution
SC-43 600 mg/day	Experimental	SC-43 Oral Solution (100 mg/ml), 6 ml by mouth, q.d. for 28 days Receives: Drug: SC-43 Oral Solution
SC-43 900 mg/day	Experimental	SC-43 Oral Solution (100 mg/ml), 9 ml by mouth, q.d. for 28 days Receives: Drug: SC-43 Oral Solution
SC-43 1200 mg/day	Experimental	SC-43 Oral Solution (100 mg/ml), 12 ml by mouth, q.d. for 28 days Receives: Drug: SC-43 Oral Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

maximum tolerated dose (MTD)
The highest dose level at which < 2 of 6 subjects experienced a dose limiting toxicity during the first 28 days of the treatment period.
Measured: 28 days

Secondary outcomes (5)

Objective response rate (ORR) according to RECIST criteria version 1.1
Objective response rate (ORR) is defined as the proportion of subjects with complete response (CR) or partial response (PR) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results.
Measured: 28 days
Disease control rate (DCR) according to RECIST criteria version 1.1
Disease control rate (DCR) is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results.
Measured: 28 days
The maximum plasma concentration (Cmax)
PK blood samples will be collected at predefined time intervals, and the maximum plasma concentration will be determined.
Measured: 28 days
Area under the plasma concentration versus time curve (AUC)
PK blood samples will be collected at predefined time intervals, and the AUC from time 0 to the last time point will be calculated.
Measured: 28 days
Number of patients with treatment-related adverse events (AEs) based on NCI-CTCAE version 5.0
An adverse event (AE) means any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. All AEs will be assessed for severity based on NCI-CTCAE version 5.0.
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2021Jun 2023

First posted23 Feb 2018
Study startMay 2021 (estimated)
Primary completionDec 2022 (estimated)
Study completionJun 2023 (estimated)

Why it stopped: Another study has been started in other country.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Refractory Solid 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03443622
Sponsor's protocol ID: SC-43-01
Status last verified: Oct 2020
First submitted: 7 Feb 2018
Last updated: 22 Oct 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)
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Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)
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Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)
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Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma

All Refractory Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Open-Label Dose-Escalating Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of SC-43 Oral Solution in Subjects With Refractory Solid Tumors
ClinicalTrials.gov ID: NCT03443622
Acronym / sponsor ID: SC-43-01
Conditions: Refractory Solid Tumor
Keywords: SC-43, refractory solid tumor, Phase I
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Another study has been started in other country.
Enrolment: 0 participants (actual)
Lead sponsor: SupremeCure Pharma Inc.Industry (pharma, biotech, devices)
Study start: May 2021 (estimated)
Primary completion: Dec 2022 (estimated)
Study completion: Jun 2023 (estimated)
First posted: 23 Feb 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
SC-43 100 mg/day	Experimental	Drug: SC-43 Oral SolutionSC-43 Oral Solution (100 mg/ml), 1 ml by mouth, q.d. for 28 days
SC-43 200 mg/day	Experimental	Drug: SC-43 Oral SolutionSC-43 Oral Solution (100 mg/ml), 2 ml by mouth, q.d. for 28 days
SC-43 400 mg/day	Experimental	Drug: SC-43 Oral SolutionSC-43 Oral Solution (100 mg/ml), 4 ml by mouth, q.d. for 28 days
SC-43 600 mg/day	Experimental	Drug: SC-43 Oral SolutionSC-43 Oral Solution (100 mg/ml), 6 ml by mouth, q.d. for 28 days
SC-43 900 mg/day	Experimental	Drug: SC-43 Oral SolutionSC-43 Oral Solution (100 mg/ml), 9 ml by mouth, q.d. for 28 days
SC-43 1200 mg/day	Experimental	Drug: SC-43 Oral SolutionSC-43 Oral Solution (100 mg/ml), 12 ml by mouth, q.d. for 28 days

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Either gender, aged 20 to 75 years old (inclusive; the legal age of consent majority is 20 years old in Taiwan)
Life expectancy ≥ 12 weeks
With histologically or cytologically confirmed solid tumor(s) that is refractory to standard treatments, or for which a standard therapy is not available or is no longer effective
With at least one measurable target lesion as measured by MRI or CT according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
Subject who has received local therapies (such as surgery, radiation therapy, hepatic arterial embolization, or chemoembolization) is eligible. Local therapies must be completed at least 4 weeks prior to the baseline scan. However, the local therapy-treated tumor should be excluded for evaluation.

Key exclusion criteria (36 listed)

With primary central nervous system (CNS) malignancies or clinically active CNS metastases
The target solid tumor is lymphoma
Any of the following hematologic abnormalities:
Any of the following serum chemistry abnormalities:
History of organ or tissue transplantation

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
SC-43 Oral SolutionSC-43 Oral Solution has drug substance of 1-[4-chloro-3(trifluoromethyl)phenyl-3-[3-(4-cyanophenoxy)] urea, or SC-43. SC-43 inhibits tumor growth through the activation of Src homology region 2 domain-containing phosphatase-1 (SHP-1) and the repression of p-STAT3 signalings. As a result of STAT3 inhibition by SC-43 treatment, decreased cell viability and enhanced apoptosis have been observed in cancer cells. The anti-tumor activity of SC-43 was also investigated in a variety of xenograft tumor models. Administration of SC-43 provides the tumor-bearing animals survival benefits, including the reduction of tumor volume and prolonged lifespan. SC-43 has been proposed to be evaluated as an anticancer therapeutic in in subjects with refractory solid tumors in the phase I trial.	Drug	SC-43 100 mg/day, SC-43 1200 mg/day, SC-43 200 mg/day, SC-43 400 mg/day, SC-43 600 mg/day, SC-43 900 mg/day

Primary outcome

maximum tolerated dose (MTD)
Time frame: 28 days
The highest dose level at which < 2 of 6 subjects experienced a dose limiting toxicity during the first 28 days of the treatment period.

5 secondary outcomes

Objective response rate (ORR) according to RECIST criteria version 1.1
Time frame: 28 days
Disease control rate (DCR) according to RECIST criteria version 1.1
Time frame: 28 days
The maximum plasma concentration (Cmax)
Time frame: 28 days
Area under the plasma concentration versus time curve (AUC)
Time frame: 28 days
Number of patients with treatment-related adverse events (AEs) based on NCI-CTCAE version 5.0
Time frame: 28 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.

Related trials for Refractory Solid Tumor

RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
Active, not recruitingPhase 2
Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SC-43 Oral Solution in people with Refractory Solid Tumor, run by SupremeCure Pharma Inc..

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 36 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: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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 (MTD) (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443622.

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 22 Oct 2020.