← Back to Search

Other

Oral TP-1454 for Cancer

Phase 1
Recruiting
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Following approval of Amendment 5.0, patients to be enrolled during Dose Escalation with Tablets must have a histologically confirmed diagnosis of anal cancer and have received at least one line of systemic platinum-based therapy in the advanced setting. Systemic platinum therapy given in the adjuvant setting will meet this criterion if there is recurrence or metastasis within 6 months of completing adjuvant therapy. They must have received no more than 3 total lines of systemic therapy in the advanced setting, have measurable disease as outlined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1, be ≥18 years of age, have a negative pregnancy test (if female of childbearing potential), have acceptable liver function, acceptable renal function, acceptable hematologic status, acceptable coagulation status, be nonfertile or agree to use an adequate method of contraception, have read and signed the Institutional Review Board (IRB)-approved informed consent form (ICF) prior to any study-related procedure. For dose escalation in mSCCA with tablets only, patients who are HIV+ may be enrolled if specific conditions are met, and patients who have had hepatitis B or C viral infections may be enrolled if specific conditions are met.
Patients to be enrolled during Dose Escalation with capsules must have a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition (enrollment complete).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 50 months
Awards & highlights

Study Summary

This trial will test the safety of a new drug for people with cancer that has spread or gotten worse. The drug will be given alone and with other cancer drugs.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for oral cancer drugs include nausea, fatigue, diarrhea, mouth sores, loss of appetite and changes in taste. Since this is a Phase 1 trial focused on safety, monitoring for any adverse reactions will be a primary concern.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an advanced cancer that hasn't responded to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~50 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 50 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine maximum tolerated dose (MTD)
Determine recommended Ph2 dose (RP2D) of TP-1454
Secondary outcome measures
Determine antitumor activity of TP-1454.
Determine incidence of dose-limiting toxicities (DLTs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: TP-1454Experimental Treatment1 Intervention
Flat dose once or twice daily

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,742 Total Patients Enrolled
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,609 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,930 Total Patients Enrolled

Media Library

TP-1454 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04328740 — Phase 1
Anal Cancer Research Study Groups: TP-1454
Anal Cancer Clinical Trial 2023: TP-1454 Highlights & Side Effects. Trial Name: NCT04328740 — Phase 1
TP-1454 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04328740 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study currently have open enrollment?

"According to clinicaltrials.gov, this particular study is not open for recruitment at the moment and has been edited for the final time on November 18th 2022. Nevertheless, 1433 other trials are still accepting participants."

Answered by AI

What are the potential adverse effects of TP-1454 monotherapy?

"There is limited clinical data establishing TP-1454 monotherapy's safety, thus it recieved a rating of 1."

Answered by AI

In what areas is the experiment being conducted?

"This trial has 9 locations that are currently running, including the Norris Cancer Center at University of Southern California and Hoag Memorial Hospital in Los Angeles, Texas Oncology Baylor Sammons Cancer Center in Dallas, Mayo Clinic Arizona in Phoenix, plus 6 other sites."

Answered by AI

Who else is applying?

What site did they apply to?
Comprehensive Cancer Center of Nevada
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am hoping a trial may help. Chemo and Immunotherapy have not worked.
PatientReceived no prior treatments
~14 spots leftby Sep 2025