TAS0612 for Advanced or Metastatic Cancer

No longer recruiting at 3 trial locations

Overseen By Taiho Oncology, INC

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Taiho Oncology, Inc.

Must be taking: Androgen deprivation therapy

Must not be taking: CYP3A inhibitors/inducers

Disqualifiers: Cardiac condition, Brain metastases, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new oral treatment, TAS0612, for individuals with advanced or metastatic solid tumor cancer. The study consists of two parts: one to determine the appropriate dose and another to examine its effects in more detail. It suits those with advanced cancer unresponsive to other treatments, particularly prostate cancer with specific genetic changes, such as PTEN loss. Participants should have previously tried standard cancer therapies and be able to take oral medication. As a Phase 1 trial, this research aims to understand how the treatment 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 does not specify if you must stop taking your current medications, but it excludes those taking strong inhibitors or inducers of CYP3A (a liver enzyme that affects drug metabolism). It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that TAS0612 is likely to be safe for humans?

Research shows that TAS0612 remains in the early stages of human testing, so information about its safety is limited. The drug is under study for advanced or metastatic cancer, but specific safety results from human trials are not yet available.

Preclinical studies, conducted in the lab or on animals before human trials, suggest that TAS0612 may help fight tumors. However, these studies do not indicate how well humans can tolerate the drug or what side effects it might cause.

Since this trial is in its first phase, the main goal is to determine the drug's safety and identify any side effects in humans. Researchers closely monitor drugs in early trial phases for any side effects. This step ensures the treatment is safe for further testing.

At this stage, it is crucial to observe any unwanted effects and assess how participants' bodies react to the drug. Prospective participants should consult their healthcare provider to understand the possible risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TAS0612 because it offers a fresh approach to treating advanced or metastatic cancer. Unlike many existing therapies that target cancer broadly, TAS0612 is designed to be taken orally, potentially offering a more convenient and less invasive option for patients. Additionally, its unique mechanism of action may provide new avenues for tackling cancer cells that have been resistant to traditional treatments. This combination of innovative delivery and targeted action makes TAS0612 a promising candidate in the fight against challenging cancer types.

What evidence suggests that TAS0612 might be an effective treatment for advanced or metastatic cancer?

Research has shown that TAS0612 is a promising treatment for various types of cancer. It targets three key proteins—RSK, AKT, and S6K—that aid cancer cell growth. Studies have found that TAS0612 can effectively halt the growth of cancer cells, particularly those resistant to other treatments. It has also demonstrated strong effects against various cancer cell types, including B-cell lymphomas. These findings suggest that TAS0612 could slow or stop cancer progression. Participants in this trial will receive TAS0612 in either the escalation or expansion phase to further evaluate its effectiveness. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My organs are functioning well.

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

Exclusion Criteria

I cannot swallow or digest pills.

I have a brain tumor that originated in my brain.

My diabetes is not well-managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of TAS0612 to determine the maximum tolerated dose

28 days

Cycle 1 Day 1 through Cycle 1 Day 15

Dose Expansion

Participants receive TAS0612 at the determined dose to further evaluate safety and efficacy

28 days

Cycle 2 Day 1 and Cycle 3 Day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• TAS0612

Trial Overview 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.

How Is the Trial Designed?

Group I: TAS0612 Expansion Experimental Treatment 1 Intervention

TAS0612 administered orally

Group II: TAS0612 Escalation Experimental Treatment 1 Intervention

TAS0612 administered orally

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

Targeted therapies using BRAF and MEK inhibitors have become the standard treatment for advanced-stage BRAF V600-mutant melanoma, significantly improving patient outcomes.

Effective management of drug-related adverse events (AEs) is crucial for maximizing treatment benefits, as understanding the specific toxicity profiles of these inhibitors allows for timely adjustments in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Treatment-Related Adverse Events with Agents Targeting the MAPK Pathway in Patients with Metastatic Melanoma. Daud, A., Tsai, K.[2019]

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]

Dabrafenib plus trametinib has been approved for treating non-small cell lung cancer (NSCLC) with the BRAF V600E mutation, showing a response rate of approximately 65% and a median progression-free survival of 10-11 months based on clinical trials.

While the combination therapy has a manageable safety profile, it presents unique toxicities such as pyrexia, fatigue, and nausea, which may be unfamiliar to oncologists treating lung cancer, but can be effectively managed using strategies developed from experience in melanoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Management in Patients with BRAF V600E-Mutant Non-Small Cell Lung Cancer Treated with Dabrafenib plus Trametinib. Chalmers, A., Cannon, L., Akerley, W.[2020]

Citations

1. clinconnect.io clinconnect.io/trials/NCT04586270

A Study of TAS0612 in Participants With Advanced or The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04586270

NCT04586270 | A Study of TAS0612 in Participants With ... The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

3. aacrjournals.org aacrjournals.org/mct/article/23/2/174/733946/TAS0612-a-Novel-RSK-AKT-and-S6K-Inhibitor-Exhibits

TAS0612, a Novel RSK, AKT, and S6K Inhibitor, Exhibits ... TAS0612 effectively inhibits the growth of cancer cells refractory to MAPK and PI3K pathway inhibitors. TAS0612 efficacy regarding cancer proliferation was ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10728023/

Triple targeting of RSK, AKT, and S6K as pivotal downstream ... TAS0612 suppresses the growth of cell lines derived from various types of B‐cell lymphomas (BCLs). TAS0612 effectively induces the triple ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37906695/

TAS0612, a Novel RSK, AKT, and S6K Inhibitor, Exhibits ... TAS0612 exhibited a stronger growth-inhibitory activity against the cancer cell lines and tumor models with dysregulated signaling with the ...

6. medchemexpress.com medchemexpress.com/tas0612.html?srsltid=AfmBOormgb7NZd9dzP3QFy4ycJnva9xocnmoqJUvgH7ZS7N_8F8KRHhg

TAS0612 | Antitumor TAS0612 is the orally active inhibitor of RSK、AKT and S6K. TAS0612 has antitumor activity. For research use only. We do not sell to patients.

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-tas0612-in-participants-with-advanced-or-metastatic-solid-tumor-cancer

A Study of TAS0612 in Participants With Advanced or ... The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.