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Advanced Solid TumorPhase 1/2NCT05388435

Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients

A Phase 1/2 study testing SKL27969 in people with Advanced Solid Tumor, run by SK Life Science, Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary Objective of Part 1 (Dose Escalation Phase): Evaluate the safety and tolerability of SKL27969, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of SKL27969 Primary Objective of Part 2 (Dose Expansion Phase): Evaluate the preliminary anti-tumor activity of SKL27969 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
SKL27969
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
4 sitesUnited States
Study dates
12 Sep 2022to 1 Mar 2024
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to provide written, voluntary informed consent prior to any study-specific procedures;
  • Male and female patients at least 18 years of age at the time of informed consent;
  • Histologically or cytologically confirmed diagnosis of non-resectable or metastatic solid malignancy that is refractory (radiographic documentation of progression) or intolerant of established therapies known to provide clinical benefit for the malignancy in the opinion of the Investigator;
  • Evidence of radiological progressive disease and minimum life expectancy of at least months, in the judgement of the Investigator;
  • Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 or Response Assessment in Neuro-Oncology (RANO), with the last imaging performed within 28 days before Cycle 1 Day 1, and documented disease progression during or after their most recent line of anticancer therapy;
  • 6. Prior treatment required for the following diagnoses that are histologically and molecularly confirmed:
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  • Recurrent high-grade glioma (HGG) (e.g., anaplastic astrocytoma (high grade), recurrent ependymoma BRAFV600E or GBM) must have biopsy proven evidence according to 2021 World Health Organization (WHO) classification (Grade 3 or 4) and received:
  • Radiotherapy with at least 2 cycles of temozolomide chemotherapy
  • NSCLC of any histologic sub-type with local mutational analysis; must have received platinum-based therapy, immune checkpoint inhibitor and targeted tyrosine kinase inhibitor, if mutation present for approved agent in accordance with product labels; or
  • TNBC must have biopsy proven evidence according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and received
  • Checkpoint inhibitors for patients who are PD-L1 positive;
  • PARP inhibitors for patients with germline BRCA mutations; or
  • Targeted antibody-drug conjugates, such as Sacituzumab govitecan.
  • Must have recovered to Grade 1 from the effects of any prior investigational systemic therapies; with the exception of alopecia and Grade 2 peripheral neuropathy;
  • Recurrent HGG must be neurologically stable for 7 or more days and takes no more than 2 mg or 4 mg of dexamethasone or equivalent steroid per day;
  • ECOG performance status of 0 or 1;
  • Willing to follow the contraception requirements as outlined (refer to Section 13.2 for details):
  • For Women:
  • Women of childbearing potential:
  • Negative pregnancy test;
  • Compliant with at least 2 effective contraceptive methods (e.g., oral contraceptives, condom with spermicide, etc) used at the same time during the study and for 90 days after the last dose of study drug; and
  • Abstinence is not considered an adequate contraceptive method.
  • Women of non-childbearing potential:
  • Must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or postmenopausal (defined as no menstrual cycle for at least 12 consecutive months). b. For Men:
  • Must be surgically sterile, or compliant with a contraceptive method (effective barrier contraception, such as condom with spermicide) during the study and for 90 days from the last dose of study drug.
  • Male patients with female partner(s) of childbearing potential:
  • Female partner must use a highly effective methods of contraception (e.g., oral contraceptives, etc). Male patients with female partner(s) of non-childbearing potential (i.e., postmenopausal or surgically sterile for at least 6 months prior to Screening):
  • No additional contraception method is required.
  • Hematological and biochemical indices within the ranges shown below:
  • Hemoglobin equal to or more than 9 g/dL (transfusion to achieve this is allowed);
  • Neutrophils equal to or more than 1.5 X 10 degree/L; and
  • Platelet count equal to or more than100 X 109 degree/L (transfusion to achieve this is allowed).
  • Hepatic function: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than or equal to 1.5 X upper limit of normal (ULN), patient with liver metastases less than or equal to 5 X ULN, and serum bilirubin less than or equal to 1.5 X ULN;
  • Renal function: Creatinine clearance greater than or equal to 45 mL/min as determined by Cockcroft-Gault;
  • Cardiac function criteria: Left ventricular ejection fraction of greater than or equal to 50% as assessed by multi-gated acquisition or ultrasound/echocardiography; corrected QT interval less than or equal to 470 ms;
  • Consent to appropriate protection from direct sunlight (e.g., utilizing sunscreen daily, protective clothing, UV protection sunglasses), and avoid artificial tanning during the study participation;
  • Able to swallow oral medication; and
  • Willing and able to comply with all protocol required visits and assessments.

Who cannot join

  • Patient has had 1 or more of the following cardiac function criteria:
  • Clinically meaningful unstable angina;
  • Myocardial infarction within 6 months prior to starting the study treatment;
  • New York Heart Association Class II or greater congestive heart failure;
  • QT interval corrected using Fridericia's formula >470 msec obtained as the mean from 3 consecutive resting ECGs;
  • Clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block);
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  • Ongoing congestive heart failure or cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) greater than or equal to Grade 2 or uncontrolled atrial fibrillation;
  • Congenital long QT syndrome;
  • Cerebrovascular accident within 6 months prior to starting the study treatment; or
  • Clinically significant arterial hypertension despite medical treatment.
  • Female patient is pregnant, breast-feeding, intending to donate ova, or planning to become pregnant before, during or within at least 90 days after the final study drug administration;
  • Male patient intends to father or donate sperm during the study or for at least 90 days after the final study drug administration;
  • History of major gastrointestinal surgery, inflammation, or condition that can impair absorption of study drug;
  • Evidence of infections (including chronic hepatitis type B or C and human immunodeficiency virus (HIV) infection, if status known);
  • Active infection requiring intravenous (IV) antibiotics;
  • Prior participation in another clinical study with PRMT5 inhibitor(s);
  • Known allergies, hypersensitivity or intolerance to PRMT5 inhibitors or SKL27969 and any of its excipients;
  • Requirement of pharmacologic doses of glucocorticoids (e.g., greater than or equal to 10 mg of prednisone) with the exception of patients diagnosed with glioma;
  • Any unstable or severe ongoing medical/psychiatric conditions, as well as medical history, laboratory, imaging, ECG, or other clinically important findings that, in the opinion of the Investigator, can indicate an unacceptable risk for the patient's participation in the study;
  • Received any systemic anti-cancer therapy including but not limited to chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy, or an investigational agent within 4 weeks prior to start of study drug treatment;
  • Active secondary malignancy within 3 years except basal or squamous cell carcinoma;
  • Major surgery within 4 weeks prior to start of study drug treatment;
  • Radiation therapy within 4 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of the study drug treatment). Patients must have recovered from all acute radiotherapy-related toxicities;
  • History of alcohol or drug abuse for the past 5 years;
  • Patients must not use proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, etc) at least 7 days prior to the first dose of SKL27969 and throughout the study; or
  • Concurrent therapy with drugs known to be potent (strong or moderate) inhibitors and inducers of cytochrome P450(CYP)3A4, including grapefruit, grapefruit juice, or grapefruit-containing products and grapefruit-related citrus fruits.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • City of Hope

    Duarte, California, 91010

  • START Midwest

    Grand Rapids, Michigan, 49546

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

Other trials in United States

About this study

Official title: A Phase 1/2, Open-Label, Multicenter, Dose-Finding Study of SKL27969 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumors

Primary Objective of Part 1 (Dose Escalation Phase): Evaluate the safety and tolerability of SKL27969, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of SKL27969

Primary Objective of Part 2 (Dose Expansion Phase): Evaluate the preliminary anti-tumor activity of SKL27969

Read the detailed description

Secondary Objectives of Part 1 (Dose Escalation Phase):

  1. Characterize the pharmacokinetic (PK) profile of SKL27969
  2. Evaluate the preliminary anti-tumor activity of SKL27969

Secondary Objectives of Part 2 (Dose Expansion Phase):

  1. Investigate the safety and tolerability of SKL27969 at the RP2D in patients with selected tumor types
  2. Characterize the PK of SKL27969
Being tested
SKL27969
Keywords
Advanced Malignant Solid Tumors, Glioblastoma, Non-Small Cell Lung Cancer, Triple Negative Breast Cancer
Medical subject headings
Glioblastoma, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms

What participants receive

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

  • SKL27969Drug

    SKL27969 will be orally administered once daily on an intermittent dosing schedule (3 days on and 4 days off).

Study groups in NCT05388435
Study groupRoleWhat they receive
Part 1: Dose Escalation PhaseExperimentalPart 1 is a dose escalation phase to evaluate the safety, tolerability, and define the MTD and RP2D. Part 1 is a 3+3 design.
Receives: Drug: SKL27969
Part 2: Dose Expansion PhaseExperimentalPart 2 includes tumor-specific expansion cohorts utilizing the MTD/RP2D doses (determined from Part 1) to further explore safety and anti-tumor activity of SKL27969, in addition to the PK and PD from the patients with the selected tumor types.
Receives: Drug: SKL27969

What is being measured

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

  1. Part 1 (Dose Escalation Phase) - Numbers of participants with adverse events, dose interruptions and modifications

    Any incidence of AEs, dose interruptions and dose modifications from signing of Informed Consent Form (ICF) until discontinuation and/or protocol required Survival Follow-up is completed.

    Measured: 1 year

  2. Part 1 (Dose Escalation Phase) - Number of participants with dose limiting toxicities

    The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.

    Measured: 1 year

  3. Part 1 (Dose Escalation Phase) - Number of participants with abnormal assessments

    Post baselines changes in laboratory assessments, vital signs, electrocardiograms (ECGs) and physical examinations related to SKL27969.

    Measured: 1 year

  4. Part 2 (Dose Expansion Phase) - Number of participants with partial response data

    ORR is defined as the proportion of participants who have a partial response (PR) or better according to the RECIST version 1.1 or RANO.

    Measured: 30 months

  5. Part 2 (Dose Expansion Phase) - Number of participants with progression-free survival

    Each participant will be assessed for progression-free survival (PFS) starting from first day of treatment until disease progression according to RECIST version 1.1 or RANO.

    Measured: 30 months

  6. Part 2 (Dose Expansion Phase) - Number of participants with overall survival

    Each participant will be assessed for overall survival (OS) starting from first day of treatment until death.

    Measured: 30 months

Secondary outcomes (18)

  1. Part 1 (Dose Escalation Phase) - Number of participants with partial response data

    ORR is defined as the proportion of participants who have a partial response (PR) or better according to the RECIST version 1.1 or RANO.

    Measured: 1 year

  2. Part 2 (Dose Expansion Phase) - Number of participants with adverse events, dose interruptions and modifications

    Any incidence of AEs, dose interruptions and dose modifications from signing of Informed Consent Form (ICF) until discontinuation and/or protocol required Survival Follow-up is completed.

    Measured: 30 months

  3. Part 2 (Dose Expansion Phase) - Pharmacokinetics of SKL27969

    Will be calculated for Cmax

    Measured: 30 months

  4. Part 2 (Dose Expansion Phase) - Pharmacokinetics of SKL27969

    Will be calculated for AUC∞

    Measured: 30 months

  5. Part 2 (Dose Expansion Phase) - Pharmacokinetics of SKL27969

    Will be calculated for AUC0-t

    Measured: 30 months

  6. Part 2 (Dose Expansion Phase) - Pharmacokinetics of SKL27969

    Will be calculated for AUC0-tau

    Measured: 30 months

  7. Part 2 (Dose Expansion Phase) - Pharmacokinetics of SKL27969

    Will be calculated for tmax

    Measured: 30 months

  8. Part 2 (Dose Expansion Phase) - Pharmacokinetics of SKL27969

    Will be calculated for t½

    Measured: 30 months

  9. Part 2 (Dose Expansion Phase) - Pharmacokinetics of SKL27969

    Will be calculated for CL/F

    Measured: 30 months

  10. Part 2 (Dose Expansion Phase) - Pharmacokinetics of SKL27969

    Will be calculated for accumulation ratio (AR)

    Measured: 30 months

  11. Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

    Will be calculated for Cmax

    Measured: 30 months

  12. Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

    Will be calculated AUC∞

    Measured: 30 months

  13. Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

    Will be calculated for AUC0-t

    Measured: 30 months

  14. Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

    Will be calculated for AUC0-tau

    Measured: 30 months

  15. Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

    Will be calculated for tmax

    Measured: 30 months

  16. Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

    Will be calculated for t½

    Measured: 30 months

  17. Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

    Will be calculated for CL/F

    Measured: 30 months

  18. Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

    Will be calculated for accumulation ratio (AR)

    Measured: 30 months

Timeline

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

  1. First posted24 May 2022
  2. Study start12 Sep 2022
  3. Primary completion1 Mar 2024
  4. Study completion1 Mar 2024

Why it stopped: The study has been terminated based on portfolio prioritization. No safety trends or issues were identified at any dose level.

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part 1, Phase 1 Dose Escalation and Part 2, Phase 2 Dose Expansion
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05388435
Sponsor's protocol ID
SKL27969C001
Status last verified
Apr 2025
First submitted
15 Mar 2022
Last updated
4 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SKL27969 in people with Advanced Solid Tumor, run by SK Life Science, Inc. 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 38 inclusion and 26 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 4 May 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: The study has been terminated based on portfolio prioritization. No safety trends or issues were identified at any dose level.). 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?

Part 1 (Dose Escalation Phase) - Numbers of participants with adverse events, dose interruptions and modifications (time frame: 1 year). The study lists 6 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 NCT05388435.

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 4 May 2025.

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