TAS2940 for Advanced Cancer

No longer recruiting at 2 trial locations

Overseen By Taiho Oncology, INC

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Taiho Oncology, Inc.

Disqualifiers: Non-stable brain metastases, cardiovascular disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TAS2940 for individuals with advanced or metastatic solid tumors, which are cancers that have spread beyond their original site. The trial aims to assess the safety and tolerability of TAS2940, its interaction with the body, and its potential effectiveness against these cancers. Several groups within the study focus on different cancers, such as HER2-positive breast cancer, non-small cell lung cancer, glioblastoma, and other tumors with specific genetic traits (EGFR or HER2 changes). It suits those with advanced cancer who lack other treatment options and have solid tumors with certain genetic changes. As a Phase 1 trial, this research seeks to understand how TAS2940 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that TAS2940 is likely to be safe for humans?

Research shows that TAS2940 is a promising new treatment in early tests for certain types of cancer. It targets specific cancer mutations, particularly in the brain. In preclinical lab studies, TAS2940 demonstrated potential benefits against tumors with certain genetic changes.

Currently, researchers are testing TAS2940 on humans for the first time, collecting information about its safety. This phase aims to assess how well people tolerate the treatment and to determine the optimal dose. Since this is the initial human trial, extensive safety data is not yet available. However, advancing to human trials suggests that lab results were promising enough to proceed.

In summary, while detailed human safety results are pending, TAS2940's progress to this stage indicates initial positive findings. Staying updated as more results emerge from ongoing studies is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TAS2940 because it targets HER2 or EGFR aberrations, which are common in various advanced cancers like breast cancer, glioblastoma, and non-small cell lung cancer. Most treatments for these conditions focus on chemotherapy or targeted therapies that can have significant side effects. TAS2940 is unique as it is designed to be taken orally, potentially offering a more convenient and patient-friendly option. Moreover, it aims to improve safety and effectiveness by focusing on specific genetic markers, which might lead to better outcomes for patients who have limited treatment options.

What evidence suggests that TAS2940 might be an effective treatment for advanced cancer?

Research has shown that TAS2940 may help treat cancers with HER2 or EGFR mutations, often found in certain advanced solid tumors. In early animal studies, TAS2940 successfully shrank tumors and extended the animals' lifespans. It was particularly effective in brain tumors, indicating its ability to reach the brain. This treatment blocks the activity of certain proteins, including HER2 and EGFR, that promote cancer growth. Initial studies have demonstrated that TAS2940 can effectively target these proteins, suggesting potential benefits for patients with these cancers. Participants in this trial will enroll in different arms to assess TAS2940's effects on various cancers, including breast cancer, glioblastoma, non-small cell lung cancer, and other solid tumors. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with advanced solid tumors like breast cancer, lung cancer, or glioblastoma who have no remaining standard treatment options. Participants must have a certain type of tumor change (EGFR/HER2), measurable disease, good organ function and be in fair physical shape (ECOG PS 0-1). Those with unstable brain metastases, serious heart issues or unresolved effects from past cancer treatments cannot join.

Inclusion Criteria

My solid tumor has EGFR or HER2 changes.

My cancer is advanced, has spread, and no standard treatments are left.

I am fully active or can carry out light work.

Exclusion Criteria

I have a serious heart condition.

My brain cancer has not remained the same and is getting worse.

I am still experiencing side effects from my previous cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose, and the recommended dosing regimen of TAS2940 administered orally

1 month

Multiple visits (in-person)

Dose Expansion

Assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

6 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TAS2940

Trial Overview The study tests TAS2940's safety and effectiveness on various cancers without available therapies. It's an early-stage trial to see how the body handles the drug (pharmacokinetics/dynamics) and its initial success in shrinking tumors across different patient groups divided by their specific cancer types.

How Is the Trial Designed?

Group I: TAS2940 Dose Escalation Experimental Treatment 1 Intervention

Dose escalation will assess the safety and determine the maximum tolerated dose, the recommended phase 2 dose and the recommended dosing regimen of TAS2940 administered orally.

Group II: Dose Expansion Solid tumors Experimental Treatment 1 Intervention

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Group III: Dose Expansion Non-small Cell Lung Cancer Experimental Treatment 1 Intervention

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

Group IV: Dose Expansion Gliblastoma Experimental Treatment 1 Intervention

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.

Group V: Dose Expansion Breast Cancer Experimental Treatment 1 Intervention

Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

Who Is Running the Clinical Trial?

Taiho Oncology, Inc.

Lead Sponsor

Trials

79

Recruited

12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

In a study of 43 patients with metastatic colorectal cancer (mCRC) who were resistant to standard treatments, TAS-102 provided clinically relevant disease control in 30% of patients, particularly those treated for 6 or more cycles, with a median progression-free survival of 7.5 months and overall survival of 11.2 months.

A significant correlation was found between previous treatment success with regorafenib and the efficacy of TAS-102, suggesting that patients who responded well to regorafenib may benefit more from subsequent treatment with TAS-102.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome of patients with chemorefractory metastatic colorectal cancer treated with trifluridine/tipiracil (TAS-102): a single Italian institution compassionate use programme. Sforza, V., Martinelli, E., Cardone, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9899605/

TAS2940, a novel brain‐penetrable pan‐ERBB inhibitor, for ... TAS2940 has promising therapeutic effects in preclinical study against cancers harboring HER2/EGFR mutations, especially metastatic and primary brain tumors.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36282234/

TAS2940, a novel brain-penetrable pan-ERBB inhibitor, for ... TAS2940 was effective in the intracranial xenograft models of HER2/EGFR cancers and improved the survival of these mice. TAS2940 has promising therapeutic ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cas.16081

TAS2940, A novel brain‐penetrable pan‐ERBB inhibitor ... On day 47, tumor volumes decreased, as observed with the NCI-N87 intracranial model. Survival studies also demonstrated the efficacy of 25.0 mg/ ...

4. researchgate.net researchgate.net/publication/371297405_A_phase_1_open-label_first-in-human_study_of_TAS2940_in_patients_with_advanced_solid_tumors

A phase 1, open-label, first-in-human study of TAS2940 in ... Results showed that PCC0208027 effectively inhibited the enzyme activity of EGFR family members, including drug-sensitive EGFR mutations, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/cas.15617

TAS2940, a novel brain‐penetrable pan‐ERBB inhibitor ... TAS2940 was effective in the intracranial xenograft models of HER2/EGFR cancers and improved the survival of these mice. TAS2940 has promising ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04982926

NCT04982926 | A Study of TAS2940 in Participants With ... This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS3165

A phase 1, open-label, first-in-human study of TAS2940 in ... TAS2940 is a potent, selective, and orally bioavailable pan-ERBB inhibitor that has shown promising preclinical efficacy against cancers with a variety of HER2 ...

8. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04982926/

Clinical Trial: NCT04982926 This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the ...