What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, have distinct side effect profiles. Chemotherapy often causes neutropenia, fatigue, nausea, vomiting, and anemia. Targeted therapies, such as tyrosine kinase inhibitors, can lead to hypertension, diarrhea, liver dysfunction, and skin rashes. Immunotherapies, including checkpoint inhibitors like PD-1/PD-L1 inhibitors, can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. The severity and frequency of these side effects can vary based on the specific drug and patient factors.

What prior FDA approvals exist?

The FDA has approved several immunotherapy and targeted therapy drugs for the treatment of solid tumors, focusing on their anti-tumor activity. Pembrolizumab and nivolumab, both PD-1 inhibitors, are approved for various solid tumors including melanoma, non-small cell lung cancer, and renal cell carcinoma. Combination therapies such as nivolumab with ipilimumab (a CTLA-4 inhibitor) have also been approved. Additionally, targeted therapies like tyrosine kinase inhibitors (e.g., pazopanib) are approved for soft tissue sarcomas. These treatments reflect the growing use of immunotherapy and targeted agents in managing solid tumors.

What other types of research exist?

Promising novel alternatives to SKL27969 for solid tumor patients in 2024 include: 1) Pembrolizumab combined with bevacizumab, which has shown efficacy in various solid tumors. 2) Nivolumab and ipilimumab combination therapy, particularly effective in renal cell carcinoma and melanoma. 3) Cabozantinib combined with atezolizumab, which has demonstrated promising results in advanced renal cell carcinoma. 4) Depatuxizumab mafodotin, especially for EGFR-amplified glioblastoma. These therapies have shown significant anti-tumor activity in recent clinical trials and are expected to be relevant treatment options in 2024.

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SKL27969 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by SK Life Science, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female patients at least 18 years of age at the time of informed consent

Prior treatment required for specific diagnoses that are histologically and molecularly confirmed

Must not have

Evidence of infections or active infection requiring IV antibiotics

Major surgery or radiation therapy within specified timeframe

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SKL27969 to see if it is safe and can help reduce tumors in patients with specific types of cancer. The study will also look at how the drug moves through the body.

Who is the study for?

Adults with advanced solid tumors that are non-resectable or metastatic and have not responded to standard treatments. Participants must have completed certain prior therapies, be in stable health with a life expectancy of at least 3 months, and agree to use effective contraception. Exclusions include recent heart issues, major surgeries, active infections requiring IV antibiotics, pregnancy or breastfeeding, and known allergies to the drug's components.

What is being tested?

The trial is testing SKL27969 for safety and tolerability (Part 1) to find the highest dose patients can take without serious side effects (MTD/RP2D). In Part 2, they're looking at how well it works against tumors. The study has two phases: increasing doses to test safety first then expanding the dose group size once safe levels are found.

What are the potential side effects?

Specific side effects of SKL27969 aren't listed but generally may include typical reactions seen with cancer drugs such as nausea, fatigue, risk of infection due to lowered blood counts; organ inflammation; allergic reactions; potential impact on liver function; skin sensitivity requiring sun protection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My diagnosis was confirmed with specific tests and I have received prior treatment.

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My cancer has grown despite recent treatment, and it can be measured by scans.

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My scans show my cancer is getting worse but I am expected to live for several more months.

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My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.

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I am fully active or can carry out light work.

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My liver, kidney, and heart are functioning within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection that needs IV antibiotics.

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I haven't had major surgery or radiation recently.

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I have had major gut surgery or conditions that affect drug absorption.

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I do not have another active cancer.

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I am not allergic to PRMT5 inhibitors or SKL27969 and its ingredients.

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My heart is functioning within normal limits.

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I do not have any severe or uncontrolled health or mental conditions.

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I am not pregnant, breastfeeding, planning to donate eggs, or become pregnant soon.

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I am not taking drugs that strongly affect the enzyme CYP3A4.

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I am not using proton pump inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+3 more

Secondary study objectives

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

Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion PhaseExperimental Treatment1 Intervention

Part 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.

Group II: Part 1: Dose Escalation PhaseExperimental Treatment1 Intervention

Part 1 is a dose escalation phase to evaluate the safety, tolerability, and define the MTD and RP2D. Part 1 is a 3+3 design.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect normal cells, leading to side effects. Targeted therapy involves drugs designed to specifically target molecular abnormalities in cancer cells, such as mutations in specific genes, thereby minimizing damage to normal cells. Immunotherapy leverages the body's immune system to recognize and attack cancer cells, often by inhibiting checkpoints that prevent immune cells from attacking tumors. These mechanisms are crucial for solid tumor patients as they offer different strategies to combat cancer, potentially leading to more effective and personalized treatment options with varying side effect profiles.