What side effects are associated with this type of intervention?

Common treatments for cancer that involve inhibition of multiple tyrosine kinases and serine/threonine kinases, such as TSN084, often lead to a range of side effects. These can include gastrointestinal issues like diarrhea and nausea, hematologic toxicities such as neutropenia and thrombocytopenia, and general symptoms like fatigue and mucositis. Additionally, serious adverse events may occur, including renal insufficiency and increased risk of infections due to immunosuppression. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several FDA-approved cancer treatments target multiple tyrosine kinases and serine/threonine kinases, similar to the investigational agent TSN084. For instance, drugs like sunitinib and sorafenib are multitargeted tyrosine kinase inhibitors used in various cancers, including renal cell carcinoma and hepatocellular carcinoma. These agents inhibit multiple receptors involved in tumor growth and angiogenesis, such as VEGFR, PDGFR, and c-KIT. Additionally, temsirolimus, an mTOR inhibitor, targets serine/threonine kinases and is approved for the treatment of relapsed or refractory mantle cell lymphoma. These drugs exemplify the therapeutic strategy of targeting multiple pathways to inhibit cancer progression.

What other types of research exist?

Promising alternatives to TSN084 for cancer treatment include: 1) TRK-inhibitors for NTRK fusion-positive sarcomas, which have shown robust and long-lasting responses. 2) mTOR inhibitors like temsirolimus and everolimus, which have demonstrated efficacy in various cancers, including endometrial cancer and PEComa. 3) FGFR inhibitors such as BGJ398, which have shown efficacy in advanced solid tumors with FGFR alterations. These agents represent novel therapeutic options targeting multiple kinase pathways.

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Protein Kinase Inhibitor

TSN084 for Cancer

Phase 1

Waitlist Available

Led By Siqing Fu, MD, PhD

Research Sponsored by Tyligand Bioscience (Shanghai) Limited

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

Has a clear history of mental disorder with ongoing treatment

Use of strong inducers or inhibitors of CYP3A drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose to 28 ±7 days after last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called TSN084, which aims to stop cancer growth by blocking certain proteins. It is for patients with advanced or spreading cancers who may not respond to other treatments.

Who is the study for?

Adults (18+) with advanced or metastatic malignancies, who have an expected survival of at least 12 weeks and are not suitable for standard therapy. They must understand the study, consent to participate, and be able to follow procedures. Their organ functions should meet specific criteria, they cannot be pregnant or breastfeeding, and must agree to use contraception.

What is being tested?

TSN084 is being tested in this first-in-human trial to find the highest dose patients can take without serious side effects (MTD), identify any dose-limiting toxicities (DLT), explore how the body processes it (pharmacokinetics), check its safety profile, and see if it shrinks tumors.

What are the potential side effects?

Specific side effects of TSN084 aren't listed but may include typical reactions related to protein kinase inhibitors such as fatigue, nausea, diarrhea, liver enzyme changes, blood count variations; plus risks associated with targeting c-MET/FLT3/TRK/CDK8/19.

Eligibility Criteria

Exclusion Criteria

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

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I am currently being treated for a mental health disorder.

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I am not taking medication that strongly affects drug metabolism.

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I do not have an active syphilis or tuberculosis infection.

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My side effects from previous cancer treatments have mostly gone away.

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I have active hepatitis B with a high viral load.

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I have other health conditions that are not under control.

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I have not had major surgery in the last 4 weeks.

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I have severe lung disease or a history of it.

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I have an active hepatitis C infection with high viral levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose to 28 ±7 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose to 28 ±7 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to 28 ±7 days after last dose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Treatment-Emergent Adverse Events

Number of patients with dose limiting toxicity

Secondary study objectives

Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC 0-t)

Disease control rate (DCR)

Duration of response (DoR)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TSN084Experimental Treatment1 Intervention

0 / 9Eligibility 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

Cancer treatments often target specific molecular pathways that are crucial for tumor growth and survival. Tyrosine kinase inhibitors (TKIs) and serine/threonine kinase inhibitors, like those studied in the TSN084 trial, block enzymes that signal cancer cells to proliferate and survive. By inhibiting these kinases, these treatments can effectively halt tumor growth and induce cancer cell death. This is particularly important for cancer patients as it offers a targeted approach to treatment, potentially leading to fewer side effects compared to traditional chemotherapy, and can be effective against cancers that have specific genetic mutations or overactive signaling pathways.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Moving Synergistically Acting Drug Combinations to the Clinic by Comparing Sequential versus Simultaneous Drug Administrations.Results of an abbreviated phase-II study with the Akt Inhibitor MK-2206 in Patients with Advanced Biliary Cancer.