Study of TP-3654 in Patients With Advanced Solid Tumors

NCT03715504 | Completed Phase 1 FDA Drug

• 1 other identifier: TP-3654-101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

TP-3654 is an oral PIM inhibitor. This is a Phase 1, open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-3654 in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

Sumitomo Dainippon Pharma Oncology SDPO; Solid Tumor; Advanced Malignancy; First in Human; Phase 1; Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicities (DLTs) and treatment emergent adverse events

  28 days

• 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).

  20 months

Secondary Outcomes (2)

• Recommended Phase 2 Dose of TP-3654

  23 months

• Determine antitumor activity of TP-3654

  20 months

Study Arms (1)

Single Arm TP-3654

EXPERIMENTAL

TP-3654 by oral administration

Drug: TP-3654

Interventions

TP-3654 DRUG

oral PIM inhibitor

Single Arm TP-3654

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Have a histologically confirmed diagnosis of advanced metastatic, progressive or unresectable solid tumor
• \. Be refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.
• \. Have 1 or more tumors measurable or evaluable as outlined by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• \. Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
• \. Have a life expectancy greater than or equal to 3 months
• \. Be greater than or equal to 18 years of age
• \. Have a negative pregnancy test (if female of childbearing potential) and not currently nursing
• \. Have acceptable liver function:
• a. Bilirubin less than or equal to 1.5x upper limit of normal (ULN) (unless associated with Gilbert's syndrome b. Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) and alkaline phosphatase less than or equal to 2.5x upper limit of normal (ULN) \*If liver metastases are present, then less than or equal to 5x ULN is allowed.
• \. Have acceptable renal function:
• a. Calculated creatinine clearance greater than or equal to 30 mL/min
• \. Have acceptable hematologic status:
• a. Absolute Neutrophil Count (ANC) greater than or equal to 1500 x10\^9/L b. Platelet count greater than or equal to 100,000 x 10\^9/L c. Hemoglobin greater than or equal to 8 g/dL
• \. Have acceptable coagulation status:
• Prothrombin time (PT) within 1.5 x normal limits

You may not qualify if:

• \. History of congestive heart failure (CHF), Cardiac disease, myocardial infarction within the past 6 months prior to Cycle 1 Day 1, left ventricular ejection fraction \<45% by echocardiogram, unstable arrhythmia, 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
• \. Presence of symptomatic central nervous system metastatic disease or disease that requires local therapy such as radiotherapy, surgery, or increasing dose of steroids within the prior 2 weeks.
• \. Have severe chronic obstructive pulmonary disease with hypoxemia (defined as resting 02 saturation of less than or equal to 90% breathing room air). The use of supplemental oxygen with nasal cannula to reach \>90% saturation will not preclude study participation.
• \. Have undergone major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1
• \. Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• \. Received treatment with radiation therapy, 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
• \. Have known infection with human immunodeficiency virus, 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
• \. Have a medical conditional such as Crohn's disease 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (3)

MD Anderson

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

TP 3654

Study Officials

• Sumitomo Dainippon Pharma Oncology, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: April 16, 2019
• Primary Completion: March 30, 2021
• Study Completion: July 8, 2021
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

US (3)