What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy often causes myelosuppression, nausea, vomiting, alopecia, and mucositis. Targeted therapies can lead to hypertension, diarrhea, liver dysfunction, and skin rashes. Immunotherapy, including PD-1 and CTLA-4 inhibitors, may result in immune-related adverse events like colitis, pneumonitis, dermatitis, and endocrinopathies. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, including chemotherapy agents like paclitaxel and cisplatin, targeted therapies such as erlotinib and sunitinib, and immunotherapies like pembrolizumab and nivolumab. These treatments have been used for various types of solid tumors, including lung cancer, melanoma, and renal cell carcinoma. For instance, pembrolizumab, an anti-PD-1 therapy, is approved for metastatic melanoma and non-small cell lung cancer, while sunitinib, a tyrosine kinase inhibitor, is approved for renal cell carcinoma and gastrointestinal stromal tumors.

What other types of research exist?

Promising novel alternatives to TAS0612 for solid tumor patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in non-small cell lung cancer and other solid tumors. 2) Regorafenib and TAS-102, which have been compared for efficacy and toxicity in metastatic colorectal cancer. 3) Cabozantinib, a tyrosine kinase inhibitor, effective in medullary thyroid cancer. 4) Trabectedin, approved for advanced leiomyosarcoma and liposarcoma. These therapies have demonstrated potential in clinical trials and may be considered as alternatives in 2024.

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TAS0612 for Advanced or Metastatic Cancer

Phase 1

Waitlist Available

Research Sponsored by Taiho Oncology, Inc.

Eligibility Criteria Checklist

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

Must have

Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Cohort B: Hormone receptor positive (HR+)/HER2 negative breast cancer after progression on endocrine therapy and a CDK4/6 inhibitor

Must not have

Unable to swallow or digest pills

Have a primary brain tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to psa progression, up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called TAS0612 to see if it is safe for people with advanced or metastatic solid tumor cancer.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, excluding brain tumors. Participants must have good organ function and a performance status of 0 or 1 on the ECOG scale. Specific cohorts include those with certain genetic mutations like PTEN loss, KRAS G12D/C mutation, NF1 mutation in HER2 negative breast cancer, and HR+/HER2 negative breast cancer resistant to standard treatments.

What is being tested?

The study is testing TAS0612's safety for patients with various types of advanced solid tumors. It includes different phases: dose escalation to find the safe dosage levels and dose expansion to test effectiveness in specific patient groups defined by genetic characteristics of their cancers.

What are the potential side effects?

While not explicitly listed here, common side effects for drugs treating advanced solid tumors may include fatigue, nausea, diarrhea, decreased appetite, skin reactions at the injection site if applicable, blood count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My breast cancer is HR+/HER2- and has worsened after endocrine therapy and CDK4/6 inhibitor treatment.

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My cancer is advanced or has spread but does not originate from the brain.

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I have HER2 negative breast cancer with an NF1 mutation.

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My cancer has a KRAS G12C mutation.

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My cancer has spread beyond its original location but it's not in my brain.

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My cancer has PTEN loss or mutations.

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I am willing and able to undergo a biopsy.

Exclusion Criteria

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

Select...

I cannot swallow or digest pills.

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I have a brain tumor that originated in my brain.

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My diabetes is not well-managed.

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I have recovered from all my previous cancer treatments.

Select...

I have a serious heart condition.

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I have brain metastases that have not been treated.

Select...

I am not taking any strong medication that affects liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to psa progression, up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to psa progression, up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to psa progression, up to 12 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

Dose Limiting Toxicities (DLTs)

rPFS rate

Secondary study objectives

Disease Control Rate (DCR) per PCWG3/mRECIST1.1

Duration of Response (DOR) per PCWG3/mRECIST1.1

Overall Response Rate (ORR) per PCWG3/mRECIST1.1

+10 more

Other study objectives

Exploratory correlation of tissue and/or blood markers with tumor efficacy endpoints and/or tumor resistance to TAS0612

Exposure of TAS0612 and selected efficacy and safety measures.

Pharmacokinetics (PK): Metabolites in plasma

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: TAS0612 ExpansionExperimental Treatment1 Intervention

TAS0612 administered orally

Group II: TAS0612 EscalationExperimental Treatment1 Intervention

TAS0612 administered orally

0 / 15Eligibility 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

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as CDK4/6 inhibitors, specifically target molecular pathways involved in tumor growth and proliferation, offering a more precise approach with potentially fewer side effects. Immunotherapy, including PD-1/PD-L1 inhibitors, enhances the body's immune response against cancer cells. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment, managing expectations regarding efficacy and side effects, and exploring new therapeutic options like TAS0612, which may offer novel mechanisms of action and improved outcomes.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.New FDA oncology small molecule drugs approvals in 2020: Mechanism of action and clinical applications.Towards pathway-centric cancer therapies via pharmacogenomic profiling analysis of ERK signalling pathway.