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.

← Back to Search

Protein Kinase Inhibitor

TSN084 for Cancer

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing a new drug called TSN084 to see if it can help treat cancer. The study will assess how well the drug works and if it has any side effects.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Number of patients with dose limiting toxicity

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TSN084Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

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.

Find a Location

Who is running the clinical trial?

Tyligand Bioscience (Shanghai) LimitedLead Sponsor

3 Previous Clinical Trials

426 Total Patients Enrolled

Siqing Fu, MD, PhDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

73 Total Patients Enrolled

Media Library

TSN084 (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05300438 — Phase 1

Cancer Clinical Trial 2023: TSN084 Highlights & Side Effects. Trial Name: NCT05300438 — Phase 1

TSN084 (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05300438 — Phase 1

~16 spots leftby Mar 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.