29 Participants Needed

TAS2940 for Advanced Cancer

Recruiting at 2 trial locations
KB
TO
TO
Overseen ByTaiho Oncology, INC
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Taiho Oncology, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests TAS2940, a new drug for patients with advanced cancers who have no other treatment options. TAS2940 works by blocking proteins that help cancer cells grow. It is effective against certain types of tumors.

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.

What safety data exists for TAS2940 (also known as TAS-102 or TAS-115) in humans?

TAS-102, used for metastatic colorectal cancer, commonly causes bone marrow suppression leading to neutropenia (low white blood cell count), which is a significant side effect. TAS-115, tested in patients with solid tumors and osteosarcoma, was generally well tolerated but also caused neutropenia and other blood-related side effects in some patients. Both treatments have shown manageable toxicities in clinical studies.12345

How does the drug TAS2940 differ from other treatments for advanced cancer?

TAS2940 is unique because it is based on TRAIL (tumor necrosis factor-related apoptosis-inducing ligand), which can selectively induce cell death in cancer cells without affecting normal cells. This drug may overcome resistance seen in other treatments by using highly active TRAIL-receptor agonists and combining with agents that sensitize cancer cells to TRAIL.678910

What data supports the effectiveness of the drug TAS2940 for advanced cancer?

Research on similar drugs like TAS-102 shows it can improve survival in patients with advanced colorectal cancer who have not responded to other treatments. This suggests that TAS2940 might also be effective for advanced cancer, although more specific studies are needed.1112131415

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.
See 7 more

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.
See 1 more

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?
5Treatment groups
Experimental Treatment
Group I: TAS2940 Dose EscalationExperimental Treatment1 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 tumorsExperimental Treatment1 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 CancerExperimental Treatment1 Intervention
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations
Group IV: Dose Expansion GliblastomaExperimental Treatment1 Intervention
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations.
Group V: Dose Expansion Breast CancerExperimental Treatment1 Intervention
Dose expansion will assess preliminary anti-tumor activity in select solid tumors characterized by HER2 or EGFR aberrations

Find a Clinic Near You

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.
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

Clinical outcome of patients with chemorefractory metastatic colorectal cancer treated with trifluridine/tipiracil (TAS-102): a single Italian institution compassionate use programme. [2021]
A Phase II, Randomized, Open-Label, Multi-arm Study of TAS-115 for Castration-Resistant Prostate Cancer Patients With Bone Metastases. [2022]
A Phase I Clinical Trial of Trametinib in Combination with TAS-102 in Patients with Chemotherapy-Resistant RAS-Mutated (PIK3CA/PTEN-Wild Type) Metastatic Colorectal Cancer. [2022]
TAS-102 Monotherapy and Combination Therapy with Bevacizumab for Metastatic Colorectal Cancer. [2022]
A phase 1b expansion study of TAS-102 with oxaliplatin for refractory metastatic colorectal cancer. [2022]
Difference in Neutropenia due to Administration Schedule of TAS-102. [2020]
[A Case of Metastatic Colorectal Cancer Refractory to Standard Chemotherapies Treated with TAS-102 with Bevacizumab]. [2020]
Efficacy and safety of TAS-115, a novel oral multi-kinase inhibitor, in osteosarcoma: an expansion cohort of a phase I study. [2022]
Neutropenia as a Predictive Factor in Metastatic Colorectal Cancer Treated With TAS-102. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase I study of TAS-115, a novel oral multi-kinase inhibitor, in patients with advanced solid tumors. [2021]
Getting TRAIL back on track for cancer therapy. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Functional expression of tumor necrosis factor-related apoptosis-inducing ligand in human colonic adenocarcinoma cells. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Activation of the Akt survival pathway contributes to TRAIL resistance in cancer cells. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
TRAIL and TRAIL receptors in patients with laryngeal cancer. [2018]
Resistance of prostate cancer cells to soluble TNF-related apoptosis-inducing ligand (TRAIL/Apo2L) can be overcome by doxorubicin or adenoviral delivery of full-length TRAIL. [2013]
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