What side effects are associated with this type of intervention?

Common treatments for kidney cancer, such as targeted therapies (sunitinib, sorafenib) and immunotherapies (nivolumab, pembrolizumab), are associated with several side effects. Targeted therapies often cause hypertension, hand-foot syndrome, rash, and fatigue. Immunotherapies can lead to immune-related adverse events, including colitis, hepatitis, pneumonitis, and endocrinopathies. These side effects vary in severity and frequency, and management typically involves dose adjustments or supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney cancer, particularly focusing on immune checkpoint inhibitors and targeted therapies. Pembrolizumab, an immune checkpoint inhibitor, has been approved for use in combination with axitinib for advanced renal cell carcinoma. Other notable immune checkpoint inhibitors include nivolumab, which has been approved both as monotherapy and in combination with ipilimumab. Targeted therapies such as sunitinib, pazopanib, and axitinib have also received FDA approval for the treatment of advanced kidney cancer. These treatments work by targeting specific pathways involved in cancer growth and immune evasion, similar to the investigational approach of combining STK-012 with pembrolizumab.

What other types of research exist?

Promising novel alternatives to STK-012 for kidney cancer treatment in 2024 include: <ol> <li>Cabozantinib in combination with Atezolizumab, which has shown efficacy in advanced renal cell carcinoma (COSMIC-021 Study).</li> <li></li> </ol> Pembrolizumab with Bevacizumab, which has demonstrated positive results in metastatic renal cell carcinoma (BTCRC-GU14-003). 3. Nivolumab and Ipilimumab combination therapy, optimized for advanced renal cell carcinoma (OMNIVORE Study). 4. Lenvatinib plus Everolimus, particularly for non-clear cell renal cell carcinoma (Phase II study). 5. Atezolizumab plus Bevacizumab, which has been effective in previously untreated metastatic renal cell carcinoma (IMmotion151 trial).

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Monoclonal Antibodies

STK-012 + Pembrolizumab for Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for kidney cancer include tyrosine kinase inhibitors (TKIs) like sunitinib and cabozantinib, which block specific enzymes involved in cancer cell growth and angiogenesis, thereby inhibiting tumor proliferation and blood vessel formation. Immune checkpoint inhibitors such as nivolumab and pembrolizumab enhance the body's immune response against cancer cells by blocking proteins that prevent immune cells from attacking tumors. Combination therapies, which often include both TKIs and immune checkpoint inhibitors, aim to maximize therapeutic efficacy by targeting multiple pathways involved in cancer progression. These mechanisms are crucial for kidney cancer patients as they offer targeted approaches that can improve survival rates and reduce the side effects compared to traditional chemotherapy.

Phase 1

Recruiting

Research Sponsored by Synthekine

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Received prior IL-2-based or IL-15-based cytokine therapy

Received definitive radiotherapy within 2 weeks of the first dose of study treatment; or palliative radiotherapy (defined as < 2 weeks of radiotherapy to non-central nervous system [CNS] disease) within 1 week of the first dose of study treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called STK-012 alone and with another medication in patients with advanced solid tumors that haven't responded to usual treatments. The aim is to find the right dose and see how well it works.

Who is the study for?

This trial is for adults with certain advanced solid tumors who have tried standard treatments without success, can't tolerate them, or chose not to use them. They must provide a tumor tissue sample and if they have brain metastases, these should be treated and stable. People can't join if they've had recent cancer therapy or radiotherapy.

What is being tested?

The study tests STK-012 alone and combined with Pembrolizumab in patients with specific solid tumors. It's the first time humans are trying STK-012, starting with low doses that increase gradually to find the safest dose that works best when given together.

What are the potential side effects?

Possible side effects of STK-012 and Pembrolizumab may include immune system reactions affecting organs, fatigue, skin issues, flu-like symptoms from cytokine therapies (like fever or chills), as well as potential infusion-related reactions.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have received IL-2 or IL-15 therapy before.

Select...

I have recently had radiotherapy for cancer outside of the brain.

Select...

I haven't taken any cancer drugs or small molecule inhibitors recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse events

Dose limiting toxicities (DLTs)

Secondary study objectives

Area under the curve (AUC) of STK-012

Half-life (T1/2) of STK-012

Immunogenicity

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part F: STK-012 Q3W + pembrolizumab, pemetrexed and carboplatin dose expansionExperimental Treatment4 Interventions

STK-012 will be administered at the RP2D SC in combination with pembrolizumab IV Q3W, pemetrexed IV Q3W and carboplatin IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.

Group II: Part E: STK-012 Q3W + pembrolizumab, pemetrexed and carboplatin dose escalationExperimental Treatment4 Interventions

STK-012 will be administered in sequential ascending doses SC Q3W in combination with pembrolizumab IV Q3W, pemetrexed IV Q3W and carboplatin IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.

Group III: Part D: STK-012 Q3W monotherapy and STK-012 Q3W + pembrolizumab dose expansionsExperimental Treatment2 Interventions

STK-012 will be administered at the RP2D SC as monotherapy and in combination with a fixed dose of pembrolizumab IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.

Group IV: Part C: STK-012 Q3W + pembrolizumab dose escalationExperimental Treatment2 Interventions

STK-012 will be administered in sequential ascending doses SC Q3W in combination with a fixed dose of pembrolizumab intravenously (IV) Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.

Group V: Part B: STK-012 every three weeks (Q3W) monotherapy dose escalationExperimental Treatment1 Intervention

STK-012 will be administered in sequential ascending doses as monotherapy SC Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.

Group VI: Part A: STK-012 weekly (QW) monotherapy dose escalationExperimental Treatment1 Intervention

STK-012 will be administered in sequential ascending doses as monotherapy subcutaneously (SC) QW until unacceptable toxicity, disease progression, or withdrawal of consent.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

carboplatin

2010

Completed Phase 3

~4790

pembrolizumab

2017

Completed Phase 3

~5890

pemetrexed

2005

Completed Phase 3

~5000

0 / 3Eligibility 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

The most common treatments for kidney cancer include tyrosine kinase inhibitors (TKIs) like sunitinib and cabozantinib, which block specific enzymes involved in cancer cell growth and angiogenesis, thereby inhibiting tumor proliferation and blood vessel formation. Immune checkpoint inhibitors such as nivolumab and pembrolizumab enhance the body's immune response against cancer cells by blocking proteins that prevent immune cells from attacking tumors. Combination therapies, which often include both TKIs and immune checkpoint inhibitors, aim to maximize therapeutic efficacy by targeting multiple pathways involved in cancer progression. These mechanisms are crucial for kidney cancer patients as they offer targeted approaches that can improve survival rates and reduce the side effects compared to traditional chemotherapy.

Sunitinib: Ten Years of Successful Clinical Use and Study in Advanced Renal Cell Carcinoma.Using cumulative toxicity to identify the optimal second-line targeted therapy in patients with metastatic renal cell carcinoma: what's new?Elevating the Horizon: Emerging Molecular and Genomic Targets in the Treatment of Advanced Urothelial Carcinoma.