Oral TP-1454 for Cancer

No longer recruiting at 11 trial locations

Overseen By Mimi Lee

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sumitomo Dainippon Pharma Oncology, Inc

Must be taking: Antiretrovirals

Must not be taking: Anticonvulsants, Corticosteroids

Disqualifiers: Cardiac disease, CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TP-1454, an oral medication, to determine its safety and tolerability for people with advanced solid tumors or anal cancer. The goal is to understand how the body processes the treatment and identify any side effects. The trial seeks participants with anal cancer who have undergone at least one round of chemotherapy with platinum-based drugs and up to three total treatments for advanced cancer. 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 medication.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving any other investigational agent or have a seizure disorder requiring anticonvulsant therapy.

Is there any evidence suggesting that TP-1454 is likely to be safe for humans?

Research has shown that TP-1454, a new treatment under investigation, was safe in early lab studies, causing few harmful effects before human trials. It is now in the early stages of testing with people who have various advanced cancers to assess its safety. The treatment is an oral pill designed to target specific cancer cells.

Although this testing phase primarily focuses on safety, early human trials involve close monitoring to detect any possible side effects. This careful observation is a standard part of the process to ensure the treatment's safety for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TP-1454 because it introduces a new approach to cancer treatment by focusing on altering cancer cell metabolism. Unlike traditional chemotherapy that targets rapidly dividing cells, TP-1454 is designed to disrupt the energy production pathways specific to cancer cells, potentially reducing side effects associated with non-selective treatments. This oral drug could offer a more convenient and patient-friendly option compared to intravenous treatments, making it easier for patients to manage.

What evidence suggests that TP-1454 might be an effective treatment for cancer?

Research shows that TP-1454, the treatment under study in this trial, targets specific cells to help the body fight cancer. This treatment activates a protein called PKM2, which plays a role in cancer cell growth. Studies have found that TP-1454 can weaken certain cells that typically protect tumors, potentially allowing the body to attack cancer cells more effectively. Although limited information exists from human studies, these early findings suggest it could be useful for treating solid tumors and anal cancer. ^{1 4 5 6 7}

Who Is on the Research Team?

Jian Li, MD

Principal Investigator

Sumitomo Pharma America, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced metastatic or progressive solid tumors, including anal cancer. Participants must have had prior platinum-based therapy if they have anal cancer and no more than three systemic treatments. They should be in good physical condition (ECOG ≤1), not pregnant, and willing to use contraception. HIV+ patients can join under certain conditions.

Inclusion Criteria

I have an advanced cancer that hasn't responded to treatment.

Exclusion Criteria

I have a condition or had surgery that affects how my body absorbs food.

I have not had major surgery in the last 2 weeks.

I have lung problems that make it hard for me to breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral TP-1454 to establish the MTD and/or RP2D, and assess safety and pharmacokinetics

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term monitoring

Objective radiographic assessment to determine antitumor activity by RECIST criteria

50 months

What Are the Treatments Tested in This Trial?

Interventions

• TP-1454

Trial Overview The study tests the safety of TP-1454 as a solo treatment when taken orally by people with severe forms of cancer that have spread. It's in Phase 1, which means it's early in testing and focuses on finding the right dose without causing harm.

How Is the Trial Designed?

Group I: TP-1454 Experimental Treatment 1 Intervention

Flat dose once or twice daily

Who Is Running the Clinical Trial?

Sumitomo Dainippon Pharma Oncology, Inc

Lead Sponsor

Trials

42

Recruited

6,800+

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

Sumitomo Pharma Oncology, Inc.

Lead Sponsor

Trials

45

Recruited

7,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04328740

NCT04328740 | Phase 1 Study of Oral TP-1454 This study will evaluate the safety and tolerability of oral TP-1454 in patients with advanced metastatic or progressive solid tumors and anal cancer.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022286024035683

Comprehensive exploration of novel imidazopyrimidine ... Sommakia et al. The PKM2 activator and molecular glue TP-1454 modulates tumor-immune responses by destabilizing T-regulatory cells. Eur. J.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10813411/

Beyond PD(L)-1 Blockade in Microsatellite-Instable Cancers The PKM2 activator and molecular glue TP-1454 modulates tumor-immune responses by destabilizing T-regulatory cells. ... efficacy results from the ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20509127

Phase 1 Study of Oral TP-1454 - Clinical Trials The purpose of this study is to establish the safety of oral TP-1454 administered once daily in patients with advanced metastatic or progressive solid tumors ...

5. prnewswire.com prnewswire.com/news-releases/sumitomo-dainippon-pharma-oncology-announces-first-patient-dosed-with-tp-1454-in-patients-with-advanced-solid-tumors-301149092.html

Sumitomo Dainippon Pharma Oncology Announces First ... The primary objectives of the first-in-human, open-label study are to assess the safety of oral TP-1454 administered once daily as monotherapy ...

6. ejcancer.com ejcancer.com/article/S0959-8049(22)00926-1/fulltext

The PKM2 activator and molecular glue TP-1454 ... TP-1454 has an acceptable preclinical safety profile and is currently in a Phase I clinical trial (NCT04328740). Materials and Methods: PKM2 activity was ...

7. selleckchem.com selleckchem.com/products/tp-1454.html

TP-1454 | PKM activator | Mechanism | Concentration TP-1454 is an activator of PKM2 with AC50 of 10 Nm in biochemical assays.TP-1454 modulates tumor-immune responses by destabilizing T-regulatory cells.