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Advanced Solid TumorPhase 1NCT04328740

Phase 1 Study of Oral TP-1454

A Phase 1 study testing TP-1454 monotherapy in people with Advanced Solid Tumor and Anal Cancer, run by Sumitomo Pharma America, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety and tolerability of oral TP-1454 in patients with advanced metastatic or progressive solid tumors and anal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Anal Cancer
What is being tested?
TP-1454 monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
11 sitesUnited States
Study dates
8 Jul 2020to 25 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • 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; (Note: 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.); and
  • 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
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  • Be ≥18 years of age
  • Have a negative pregnancy test (if female of childbearing potential)
  • Have acceptable liver function:
  • Bilirubin ≤1.5x upper limit of normal (ULN) (unless associated with Gilbert syndrome)
  • Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) and alkaline phosphatase ≤2.5x ULN* *If liver metastases are present, then ≤ 3x ULN is allowed.
  • Have acceptable renal function: calculated creatinine clearance ≥60 mL/min (using Cockcroft Gault formula)
  • Have acceptable hematologic status:
  • Granulocyte ≥1500 cells/mm3
  • Platelet count ≥100,000 (plt/mm3)
  • Hemoglobin ≥8 g/dL
  • Have acceptable coagulation status:
  • International Normalized Ratio (INR) or Prothrombin time (PT) within 1.5x normal limits unless the patient is receiving anticoagulant therapy, in which case, the patient's PT or partial thromboplastin time (PTT) must be within the therapeutic range of intended use for their anticoagulant.
  • Partial activated partial thromboplastin time (aPTT) or activated partial thromboplastin time (aPTT) within 1.5x normal limits unless the patient is receiving anticoagulant therapy, in which case, the patient's PT or PTT must be within the therapeutic range of intended use for their anticoagulant.
  • Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use a highly effective method of contraception prior to study entry for the duration of study participation and for at least 3 months (males) and 6 months (females) after the last study drug dose.
  • Male patients only: must agree not to donate sperm during the study and for 3 months after the last dose of TP-1454.
  • Women of childbearing potential must agree not to donate eggs during the study and for 6 months after the last dose of TP-1454.
  • Have read and signed the Institutional Review Board (IRB)-approved informed consent form (ICF) prior to any study-related procedure. (In the event that the patient is rescreened for study participation or a protocol amendment alters the care of an ongoing patient, a new ICF must be signed.)
  • Dose escalation in mSCCA with tablets only: Patients who are HIV+ may be enrolled if the following conditions are met:
  • CD4+ T-cell count ≥ 300/µL
  • No opportunistic infection within the past 12 months
  • Treatment with established antiretroviral therapy for at least 4 weeks with a viral load < 400 copies/mL prior to first dose with TP-1454.
  • Dose escalation in mSCCA with tablets only: Patients who have had hepatitis B or C viral infections (HBV or HCV, respectively) may be enrolled if the following conditions are met:
  • Have completed or are undergoing curative antiviral treatment with viral load below the limit of quantification
  • Test positive for antibody and negative for viral RNA

Who cannot join

  • New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months or evidence of ischemia on electrocardiogram (ECG) within 14 days prior to Cycle 1/Day 1
  • Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >450 msec in men and >470 msec in women
  • Have a seizure disorder requiring anticonvulsant therapy
  • Have untreated central nervous system (CNS) metastases including carcinomatous meningitis. Patients with definitively treated (radiotherapy or surgery) CNS metastases may be eligible if asymptomatic and not receiving corticosteroids in excess of prednisone 10 mg (or equivalent) per day for ≥2 weeks before first dose of TP-1454
  • Have hypoxemia (defined as resting O2 saturation of ≤90% breathing room air)
  • Have symptomatic interstitial lung disease
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  • Have undergone major surgery within 2 weeks prior to Cycle 1/Day 1
  • Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Are pregnant or nursing
  • Received treatment with radiation therapy to a target lesion, surgery, chemotherapy, or investigational therapy within 28 days or 5 half-lives, whichever occurs first, prior to study entry (6 weeks for nitrosoureas or mitomycin C)
  • Are unwilling or unable to comply with procedures required in this protocol
  • Dose escalation in solid tumors with capsules only: Have known infection with hepatitis B, or hepatitis C. Patients with history of chronic hepatitis that is currently not active are eligible
  • Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
  • Are currently receiving any other investigational agent
  • Have exhibited allergic reactions to a similar structural compound, biological agent, or formulation(s)
  • Have malabsorption conditions or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption
  • Have a history of malignancy within the past 24 months except curatively treated in situ cancers

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Texas Oncology Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • University of Southern California - Norris Cancer Center and Hoag Memorial Hospital

    Los Angeles, California, 90033 and 92663

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: A Phase I, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic 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.

Read the detailed description

Primary Objective:

  • To establish the MTD and/or Recommended Phase 2 Dose (RP2D) of orally administered TP-1454 in patients with metastatic solid tumors and anal cancer.

Secondary Objectives:

  • To establish the pharmacokinetic (PK) profile of orally administered TP-1454
  • To observe patients for any evidence of antitumor activity of TP 1454 by objective radiographic assessment
  • To assess the safety and tolerability of TP-1454
Being tested
TP-1454 monotherapy
Keywords
Sumitomo Pharma Oncology, Phase 1, Advanced Solid Tumors, Refractory, Anal cancer
Medical subject headings
Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TP-1454 monotherapyDrug

    Flat dose once or twice daily, alone

Study groups in NCT04328740
Study groupRoleWhat they receive
TP-1454ExperimentalFlat dose once or twice daily
Receives: Drug: TP-1454 monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine maximum tolerated dose (MTD)

    MTD will be determined based upon toxicity grades which are defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.

    Measured: 50 months

  2. Determine recommended Ph2 dose (RP2D) of TP-1454

    To establish the RP2D for future studies with TP-1454. MTD, PK and PD data to be reviewed.

    Measured: 50 months

  3. Incidence of SAEs and AEs resulting in study discontinuation, as assessed by NCI NTCAE v5.0

    With approval of protocol amendment 7, the primary objective of this study is to continue to monitor the safety and tolerability of TP-1454 in ongoing patients.

    Measured: From date of treatment through 30 days after End of Treatment, an average of 6 months

Secondary outcomes (2)

  1. Determine incidence of dose-limiting toxicities (DLTs)

    A DLT is defined as a drug-related toxicity that is observed to occur within the first 28 days

    Measured: 28 days

  2. Determine antitumor activity of TP-1454.

    Objective radiographic assessment to be performed to determine antitumor activity by Response Evaluation Criteria in Solid Tumors (RECIST criteria v 1.1).

    Measured: 50 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2020
  2. Study start8 Jul 2020
  3. Primary completion25 Apr 2025
  4. Study completion25 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Open label
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04328740
Sponsor's protocol ID
TP-1454-101
Status last verified
Apr 2025
First submitted
20 Mar 2020
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TP-1454 monotherapy in people with Advanced Solid Tumor and Anal Cancer, run by Sumitomo Pharma America, Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine maximum tolerated dose (MTD) (time frame: 50 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04328740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

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