Oral TP-1454 for Cancer

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

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a new oral drug called TP-1454 in patients with advanced metastatic or progressive solid tumors and anal cancer. The study aims to find the best dose and see how the drug moves through the body. Researchers will also check if TP-1454 can help shrink tumors.

Research Team

Jian Li, MD

Principal Investigator

Sumitomo Pharma America, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+