Phase 1 Study of Oral TP-1454

Completed · Phase 1

Conditions studied: Advanced Solid Tumor, Anal Cancer

In brief

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

Key facts

Study ID: NCT04328740
Run by: Sumitomo Pharma America, Inc.
People needed: 31
Starts: 2020-07-08
Expected to finish: 2025-04-25
Last updated by the study team: 2025-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

You may not qualify if…

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
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

Where it is running

Mayo Clinic Arizona — Phoenix, Arizona, United States
University of Southern California - Norris Cancer Center and Hoag Memorial Hospital — Los Angeles, California, United States
Mayo Clinic Jacksonville — Jacksonville, Florida, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Comprehensive Cancer Center of Nevada — Las Vegas, Nevada, United States
Vanderbilt University — Nashville, Tennessee, United States
Texas Oncology Baylor Sammons Cancer Center — Dallas, Texas, United States
MD Anderson Cancer Center — Houston, Texas, United States
Huntsman Cancer Institute — Salt Lake City, Utah, United States
University of Virginia — Charlottesville, Virginia, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.