What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like carboplatin and paclitaxel can cause side effects such as nausea, vomiting, hair loss, and increased risk of infection. Targeted therapies, such as dabrafenib for BRAF(V600E)-positive NSCLC, may lead to skin issues like cutaneous squamous-cell carcinoma and other serious adverse events. Immunotherapy drugs like pembrolizumab and durvalumab can result in immune-related side effects, including pneumonitis, rash, and diarrhea. These treatments aim to improve survival and quality of life but come with a range of potential side effects that need to be managed carefully.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. For instance, pembrolizumab, an anti-PD-1 therapy, has shown significant improvement in overall survival and progression-free survival when combined with chemotherapy in advanced squamous NSCLC. Additionally, selpercatinib and pralsetinib are approved for RET fusion-positive NSCLC, demonstrating high response rates. These treatments, like TOS-358, aim to provide targeted and personalized therapeutic options for NSCLC patients.

What other types of research exist?

Promising novel alternatives to TOS-358 for NSCLC patients include: 1) Amrubicin, which has shown significant clinical activity with manageable toxicities as a third- or fourth-line therapy for advanced NSCLC. 2) LY01008, a bevacizumab biosimilar, which demonstrated similar efficacy and safety to Avastin in Chinese patients with advanced or recurrent non-squamous NSCLC. 3) Immune checkpoint inhibitors (ICIs) combined with other therapies, which have shown better progression-free survival (PFS) compared to conventional chemotherapy in patients with EGFR-TKI resistance. 4) Pembrolizumab combined with chemotherapy, which improved overall survival (OS) and PFS in patients with advanced squamous NSCLC.

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TOS-358 for Cancer

Phase 1

Recruiting

Research Sponsored by Totus Medicines

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 up to 5 years

Awards & highlights

Summary

This trial tests TOS-358, a new drug for adults with specific cancers that have a genetic mutation. It aims to find the safest dose and see how well patients tolerate it. The drug works by blocking a gene that helps cancer cells grow.

Who is the study for?

Adults over 18 with certain advanced solid tumors and specific genetic changes (PIK3CA mutations/amplifications) can join. They should have a life expectancy of at least 3 months, be able to consent, have measurable disease, good performance status (ECOG 0 or 1), and proper organ function. Excluded are those with diabetes, obesity (BMI ≥30), recent cancer treatments, heart issues within the past six months, prior PI3K pathway inhibitors use (except some breast cancer patients), other recent cancers or active brain metastases.

What is being tested?

TOS-358 is being tested for safety in adults with select solid tumors. The study will determine the highest dose patients can tolerate when taken orally once or twice daily without severe side effects and establish a recommended dose for future studies.

What are the potential side effects?

While specific side effects of TOS-358 aren't listed here, common ones from drugs targeting the PI3K-AKT-mTOR pathway may include diarrhea, skin rash, fatigue, high blood sugar levels and infections. Side effects often vary based on dosage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: TOS-358 Single Agent ArmExperimental Treatment1 Intervention

Multiple doses of TOS-358 for oral administration.

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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cancer cells but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), specifically target genetic mutations in cancer cells, inhibiting their growth and survival. Immunotherapies, like checkpoint inhibitors, enhance the body's immune response against cancer cells. Understanding these mechanisms helps in selecting the most appropriate treatment based on the tumor's genetic profile and the patient's health, potentially improving outcomes and minimizing side effects.

Non-Radiation Based Early Pain Relief Treatment Options for Patients With Non-Small Cell Lung Cancer and Cancer Induced Bone Pain: A Systematic Review.

Find a Location

Who is running the clinical trial?

Totus MedicinesLead Sponsor

Glenn Michelson, MDStudy DirectorTotus Medicines

4 Previous Clinical Trials

159 Total Patients Enrolled

Ovid Trifan, MD, PhDStudy DirectorTotus Medicines

Media Library

TOS-358 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05683418 — Phase 1

Squamous Cell Carcinoma Research Study Groups: TOS-358 Single Agent Arm

Squamous Cell Carcinoma Clinical Trial 2023: TOS-358 Highlights & Side Effects. Trial Name: NCT05683418 — Phase 1

TOS-358 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683418 — Phase 1

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