What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those involving RET inhibitors like TAS0953/HM06, often include targeted therapies and chemotherapy. Known side effects of RET inhibitors can include hypertension, liver function abnormalities, diarrhea, and fatigue. Broader side effects for common solid tumor treatments may also encompass nausea, vomiting, neutropenia, anemia, and increased risk of infections. These side effects vary depending on the specific drug and patient condition.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors with specific genetic abnormalities. For instance, selpercatinib and pralsetinib are RET inhibitors approved for treating non-small cell lung cancer (NSCLC) and thyroid cancers with RET gene fusions or mutations. These drugs work by specifically inhibiting the activity of the RET protein, which is involved in cell growth and division. Other targeted therapies for solid tumors include drugs like vemurafenib and dabrafenib, which target BRAF mutations in melanoma, and trastuzumab, which targets HER2-positive breast cancer.

What other types of research exist?

Promising alternatives to TAS0953/HM06 for solid tumors with RET gene abnormalities include selpercatinib and pralsetinib. Both have demonstrated efficacy in treating RET fusion-positive cancers and are approved for use in various solid tumors.

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Kinase Inhibitor

RET Inhibitor for Solid Cancers ((MARGARET) Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Helsinn Healthcare SA

Eligibility Criteria Checklist

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

Must have

Phase I Dose-Escalation - Specific inclusion criteria: Advanced solid tumors

Phase I Dose-Expansion - Specific inclusion criteria: Locally advanced or metastatic non small cell lung cancer (NSCLC) patients with primary RET gene fusion and prior exposure to RET selective inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of death due to any cause, assessed up to an average of 2 years

Awards & highlights

(MARGARET) Trial Summary

This trial is testing a new drug, TAS0953/HM06, to see if it is safe and effective in treating patients with advanced solid tumors with RET gene abnormalities.

Who is the study for?

This trial is for adults with advanced solid tumors that have specific RET gene abnormalities. Participants should be in good physical condition (ECOG score of 0-1 or 2), have adequate organ function, and no major recent surgeries. They must not have certain genetic mutations like EGFR or KRAS, uncontrolled heart issues, or a history of severe heart rhythm problems.Check my eligibility

What is being tested?

The study tests TAS0953/HM06's safety and effectiveness on patients with RET-related tumors. Phase 1 determines the safest high dose to use; Phase 2 uses this dose to further evaluate treatment effects.See study design

What are the potential side effects?

While the side effects for TAS0953/HM06 are not detailed here, similar drugs often cause tiredness, nausea, changes in blood pressure or heartbeat, liver issues, and potential allergic reactions.

(MARGARET) Trial Eligibility Criteria

Inclusion Criteria

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

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I have an advanced solid tumor.

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I have advanced lung cancer with a RET gene mutation and have been treated with RET inhibitors.

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I am fully active or have some restrictions but can still care for myself.

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My cancer has RET gene changes found in a biopsy.

(MARGARET) Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of death due to any cause, assessed up to an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of death due to any cause, assessed up to an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death due to any cause, assessed up to an average of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)

Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)

Phase 2: Objective Response Rate (ORR) by independent data monitoring committee (IDMC)

Secondary outcome measures

Phase 1 (dose expansion): Objective Response Rate (ORR) by IDMC

Phase 1 (dose-escalation): AUC0-12 at steady state

Phase 1 (dose-escalation): AUC0-24

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(MARGARET) Trial Design

2Treatment groups

Experimental Treatment

Group I: TAS0953/HM06 Phase 2Experimental Treatment1 Intervention

Treatment phase at recommended Phase 2 dose in three different populations

Group II: TAS0953/HM06 Phase 1Experimental Treatment1 Intervention

Dose escalation and dose expansion until recommended Phase 2 dose determined

0 / 4Eligibility 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

RET inhibitors, such as TAS0953/HM06, work by targeting and blocking the RET signaling pathway, which is often abnormally activated in certain solid tumors. This targeted approach is significant for patients with RET gene abnormalities as it offers a personalized treatment option that can more effectively inhibit tumor growth and survival while potentially reducing side effects compared to conventional chemotherapy. Understanding these mechanisms is essential for developing new treatments and overcoming drug resistance, ultimately improving patient outcomes.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Therapeutic approaches for relapsed/refractory adult acute lymphoblastic leukemia (ALL), a review on monoclonal antibodies and targeted therapies.