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Advanced Solid TumorPhase 1NCT05971862

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SKI-G-801 in Patients With Advanced Solid Tumors

A Phase 1 study testing SKI-G-801 in people with Advanced Solid Tumor, run by Oscotec Inc. at 3 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase I study intended to determine the MTD and RP2D of SKI-G-801 monotherapy by assessing the safety and tolerability including dose-limiting toxicity (DLT) at various dose levels and to explore the efficacy and PK in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
SKI-G-801
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesSouth Korea
Study dates
25 Jan 2022to 4 Oct 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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female adults aged 19 years and older
  • Subjects with histologically and/or cytologically confirmed, unresectable advanced or metastatic solid tumors that are confirmed as PD after the standard of care currently known to have clinical benefits, or for which no currently available standard therapies exist due to intolerance, ineligibility, refusal, etc.
  • At least 1 evaluable lesion based on RECIST version 1.1 (the irradiated area or biopsied lesion will be considered evaluable if PD is demonstrated).
  • The Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
  • Life expectancy of at least 12 weeks
  • The last screening test results obtained within 7 days prior to the first dose of the IP (baseline) meet the following (with no administration of granulocyte colony-stimulating factor [G-CSF] or erythropoietin [EPO], or transfusion within 14 days prior to the laboratory tests)
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  • Hematological function ANC ≥1,500/μL Hemoglobin ≥9 g/dL Platelet count ≥100,000/μL
  • Renal function: Creatinine clearance (CrCl) ≥45 mL/min (MDRD equation)
  • Hepatic function AST ≤2.0 × ULN ALT ≤2.0 × ULN (AST/ALT ≤5 × ULN, if hepatic metastasis is confirmed) Total bilirubin ≤1.5 × ULN (<3.0 × ULN, if Gilbert's syndrome is confirmed)
  • Blood coagulation function: prothrombin time (PT) (international normalized ratio [INR]) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (with an exception of PT or aPTT in the therapeutic range as per the purpose of anticoagulants if the subject is taking anticoagulants such as warfarin, heparin, or low molecular weight heparin)
  • Voluntary written consent to participate in this study

Who cannot join

  • 7th line or greater palliative systemic anti-cancer therapy for advanced or metastatic solid tumors (postoperative adjuvant therapy is considered as a single line of therapy if the disease recurs within 6 months after the last treatment, while endocrine therapy is excluded from the line of therapy)
  • History of AXL inhibitors
  • Difficulty (e.g., problem swallowing) in oral administration of SKI-G-801 or disease (celiac disease, Crohn's disease, or intestinal resection which is clinically significant or impacts absorption) which impact absorption
  • Hypersensitivity to the active ingredient or excipients of SKI-G-801
  • Major surgery within 4 weeks prior to IP administration
  • Minor surgery within 2 weeks prior to IP administration
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  • Women who have a positive pregnancy test or are pregnant or breastfeeding at screening, or female subjects of childbearing potential or male subjects who do not agree to remain abstinent or use effective methods of contraception** for at least 27 weeks (female subjects) or 14 weeks (male subjects) after the last dose of the IP
  • Effective forms of contraception are defined as the following:
  • Hormonal contraceptives (implants, injectables, oral contraceptives, etc.)
  • Intrauterine device or intrauterine system (copper loop, hormone containing intrauterine system)
  • Surgical sterilization (vasectomy, tubal ligation, etc.) of a subject or spouse (or partner)
  • Double-barrier method with spermicide (including condom, diaphragm, vaginal sponge, or cervical cap; a male and a female condom must not be used together)
  • Toxicity associated with prior anti-cancer therapy that does not resolve to Grade ≤1 or baseline (with the exceptions of alopecia [any grade], Grade ≤2 neuropathy, and endocrinopathy that is not controlled by hormone replacement therapy)
  • History of using another investigational product/device within 4 weeks (or 5 half-lives, whichever is shorter) prior to IP administration
  • Ineligibility or inability to participate in the study at the judgement of the investigator

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Yonsei University College of Medicine Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: An Open-label, Multi-center, Dose-escalation and Dose-finding, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SKI- G-801 as Monotherapy in Patients With Advanced Solid Tumors

This is a phase I study intended to determine the MTD and RP2D of SKI-G-801 monotherapy by assessing the safety and tolerability including dose-limiting toxicity (DLT) at various dose levels and to explore the efficacy and PK in patients with advanced solid tumors.

Read the detailed description

This is an open-label, monotherapy study in patients with advanced solid tumors, to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of SKI-O-801(Denfivontinib). A total of 36 subjects are planned to participate in 6 cohorts (traditional 3+3 design). In each cohort, 3 subjects will receive SKI-O-801. Dosing will be initiated with a 100 mg once daily (QD) dose cohort and escalated to 500 mg QD. After 1 cycle (28 days) of treatment if 3 subjects in each cohort have no DLT(Dose Limiting Toxicity), escalate the next dose level by Safety Review Committee decision.

Being tested
SKI-G-801

What participants receive

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

  • SKI-G-801Drug

    Also called Denfivontinib

    Oral SKI-G-801(Denfivontinib) will be daily administered based on dose level.

Study groups in NCT05971862
Study groupRoleWhat they receive
SKI-G-801(Denfivontinib) 100mg QDExperimentalAdministered orally
Receives: Drug: SKI-G-801
SKI-G-801(Denfivontinib) 150mg QDExperimentalAdministered orally
Receives: Drug: SKI-G-801
SKI-G-801(Denfivontinib) 225mg QDExperimentalAdministered orally
Receives: Drug: SKI-G-801
SKI-G-801(Denfivontinib) 300mg QDExperimentalAdministered orally
Receives: Drug: SKI-G-801
SKI-G-801(Denfivontinib) 400mg QDExperimentalAdministered orally
Receives: Drug: SKI-G-801
SKI-G-801(Denfivontinib) 500mg QDExperimentalAdministered orally
Receives: Drug: SKI-G-801

What is being measured

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

  1. Determination of the MTD and/or RP2D based on DLTs

    For DLTs, the number of subjects, incidence, and number of events will be presented by dose group

    Measured: Study Day 1 up to Day 28 (each cycle is 28 days)

  2. The number of treatment discontinuation or dose reduction

    The number of treatment discontinuation or dose reduction due to ADRs(Adverse Drug Reactions) will be presented by dose group.

    Measured: Approximately 2 year

  3. AEs(Adverse event)

    The number of AEs, the number of subjects affected, and the incidence will be presented.

    Measured: Approximately 2 year

  4. Laboratory tests

    The number of participants with abnormal Laboratory test results such as hematology and chemistry lab results.

    Measured: Approximaely 8 weeks

Secondary outcomes (3)

  1. Cmax

    Maximum Plasma Concentration of SKI-G-801

    Measured: Approximately 29 days (Up to Cycle 2 Day 1)

  2. AUC

    Area under the plasma concentration versus time curve of SKI-G-801

    Measured: Approximately 29 days (Up to Cycle 2 Day 1)

  3. Objective Response Rate (ORR)

    The frequency and percentage of ORR will be presented by dose group using best overall response (BOR) based on RECIST version 1.1

    Measured: Approximately 2 year

Timeline

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

  1. First posted2 Aug 2023
  2. Study start25 Jan 2022
  3. Primary completion23 Apr 2024 (estimated)
  4. Study completion4 Oct 2024 (estimated)

Resources

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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05971862
Sponsor's protocol ID
OSCO-P1302
Status last verified
Feb 2024
First submitted
29 Jun 2023
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SKI-G-801 in people with Advanced Solid Tumor, run by Oscotec Inc. at 3 sites in South Korea.

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 11 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. 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?

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?

Determination of the MTD and/or RP2D based on DLTs (time frame: Study Day 1 up to Day 28 (each cycle is 28 days)). The study lists 4 primary outcomes in all. 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 NCT05971862.

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 21 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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