Oral TACH101 for Cancer

Recruiting at 8 trial locations

Overseen By Chan Chandhasin, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Tachyon Therapeutics, Inc.

Must not be taking: Anticancer therapy

Disqualifiers: Brain metastases, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral medication called TACH101 in patients with advanced and metastatic solid tumors. Researchers aim to find the best dose that patients can handle and see if it can shrink or stop the tumors. They are also checking how safe the medication is for these patients.

Will I have to stop taking my current medications?

The trial requires that you stop any ongoing anticancer therapy at least 4 weeks or 5 half-lives before the first dose. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug TACH101 for cancer treatment?

Research on a similar compound, TAC-101, shows it can reduce tumor growth in colon cancer by blocking a protein called VEGF, which helps tumors grow blood vessels. This suggests that TACH101 might also be effective in treating cancer by a similar mechanism. ^{1 2 3 4 5}

What safety data exists for TACH101 or similar treatments?

The treatment TAS-102, which may be similar to TACH101, has been associated with neutropenia (a low level of white blood cells), which is a common side effect. This condition can affect the body's ability to fight infections. ^{2 6 7 8 9}

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, including gastrointestinal cancers and MSI-H colorectal cancer that didn't respond to standard treatments. Participants must have measurable disease, be in good physical condition (ECOG score 0-1), and meet specific blood count and organ function criteria. Women of childbearing potential must test negative for pregnancy and agree to use contraception.

Inclusion Criteria

I have advanced GI tumors or MSI-H CRC that hasn't responded well to standard treatments.

I am fully active or can carry out light work.

My advanced cancer hasn't responded to treatment and there's no standard cure.

Exclusion Criteria

I do not have serious heart conditions like heart attacks, uncontrolled high blood pressure, or irregular heartbeats.

For Phase 1b, prior participation in Phase 1a

Known or suspected hypersensitivity to any components of the formulation used for TACH101

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive TACH101 in a 48-hour lead-in period followed by repeated dosing at different regimens in each 28-day cycle

Up to approximately 204 days

Dose Expansion

Participants receive TACH101 at the RP2D identified in Phase 1a, with two cohorts enrolled: gastrointestinal cancers and MSI-H metastatic CRC

Up to approximately 203 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• TACH101

Trial Overview The study tests TACH101's safety, tolerability, dosage levels, how the body processes it, and its effectiveness against tumors. It has two parts: Phase 1a finds the highest dose patients can take without serious side effects; Phase 1b determines a recommended dose for future studies based on responses from participants.

Participant Groups

Group I: Phase 1b: Dose Expansion Experimental Treatment 1 Intervention

In Phase 1b, participants will receive TACH101 at the RP2D identified in Phase 1a. Two cohorts of participants will be enrolled: * Participants with gastrointestinal cancers. * Participants with high microsatellite instability (MSI-H) metastatic colorectal cancer (CRC).

Group II: Phase 1a: Dose Escalation Experimental Treatment 1 Intervention

In Phase 1a, participants will receive TACH101 in a 48 hour lead in period followed by repeated dosing at different dosing regimens in each 28 day cycle.

Who Is Running the Clinical Trial?

Tachyon Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

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]

TAS-102 significantly improves overall survival (OS), progression-free survival (PFS), and disease control rate (DCR) in patients with metastatic colorectal cancer (mCRC) compared to placebo or best supportive care, based on a meta-analysis of 2903 patients.

The treatment is effective regardless of KRAS mutation status and does not increase the incidence of serious adverse events, indicating that TAS-102 is both effective and safe for patients whose standard therapies have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of trifluridine/tipiracil (TAS-102) in patients with metastatic colorectal cancer: a systematic review and meta-analysis. Huang, F., Yang, H., Bao, W., et al.[2023]

In a study of 41 patients with metastatic colorectal cancer, TAS-102 significantly improved overall survival and progression-free survival, especially when combined with bevacizumab.

Biweekly administration of TAS-102 resulted in significantly less grade ≥3 neutropenia compared to standard administration, suggesting that adjusting the administration method can help manage side effects while maintaining treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biweekly Administration of TAS-102 for Neutropenia Prevention in Patients with Colorectal Cancer. Yoshida, Y., Sakamoto, R., Kajitani, R., et al.[2020]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

TAS-102 monotherapy for pretreated metastatic colorectal cancer: a double-blind, randomised, placebo-controlled phase 2 trial. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Efficacy and safety of trifluridine/tipiracil (TAS-102) in patients with metastatic colorectal cancer: a systematic review and meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

4-[3,5-Bis(trimethylsilyl)benzamido] benzoic acid inhibits angiogenesis in colon cancer through reduced expression of vascular endothelial growth factor. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Profile of trifluridine/tipiracil hydrochloride in the treatment of metastatic colorectal cancer: efficacy, safety, and place in therapy. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

Biweekly Administration of TAS-102 for Neutropenia Prevention in Patients with Colorectal Cancer. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Difference in Neutropenia due to Administration Schedule of TAS-102. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Neutropenia as a Predictive Factor in Metastatic Colorectal Cancer Treated With TAS-102. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A phase 1b expansion study of TAS-102 with oxaliplatin for refractory metastatic colorectal cancer. [2022]