A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors

NCT ID: NCT02223247

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-06-30

Brief Summary

This first in human phase 1 study of TVB-2640 is being conducted in patients with advanced stage solid malignant tumors. This research is being done to find out how safe and useful TVB-2640 is for patients who have received previous cancer therapy, and for whom no therapy exists that would be curative or might provide significant benefit. TVB-2640 belongs to a class of drugs called fatty acid synthase inhibitors (FASN inhibitors). This means that they interfere with the body's (and the tumor's) ability to use a substance called fatty acid synthase (FASN). Research has shown that some tumors appear to need FASN to keep growing.

Conditions

Solid Malignant Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TVB-2640

Oral TVB-2640 capsules or tablets of various dose strengths administered QD for 21 - 28 day dosing cycles, alone or in combination with certain standard chemotherapy agents

Group Type: EXPERIMENTAL

TVB-2640

Intervention Type: DRUG

Interventions

TVB-2640

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has histologically- or cytologically- confirmed metastatic or advanced-stage solid malignant tumor that is refractory to standard therapy and for whom no therapy exists that would be curative or might provide significant benefit and therefore for whom experimental therapy is a reasonable option.
• Patient experienced progressive disease during or following or was intolerant of their most recent treatment regimen.
• Patient is male or female aged ≥18 years.
• Patient has an ECOG performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), as assessed on C1D1, before the first dose of TVB 2640.
• Patient has adequate renal function (creatinine ≤1.5 times the upper limit of normal [ULN]) or a glomerular filtration rate (GFR) of ≥50 mL/min.
• Patient has adequate hepatic function,
• Patient has adequate bone marrow function
• Patient has no significant ischemic heart disease or myocardial infarction (MI) within 6 months before the first dose of TVB 2640 and currently has adequate cardiac function

For the Monotherapy Expansion Cohorts of the Study ONLY:

• Patient has a specific tumor-type and histology, as designated by the Sponsor based on nonclinical and clinical data obtained prior to enrollment in the Expansion Cohort.
• Patient has measurable disease, as determined by the Investigator using RECIST, version 1.1 (1).

For the Combination Cohorts ONLY:

• In addition to meeting monotherapy criteria above, the commercially-available anticancer agent of interest being investigated in combination with TVB-2640, administered according to the dose regimen in the prescribing information, is deemed appropriate for the patient's disease and clinical status.

Exclusion Criteria

• Patient is unable to swallow oral medications or has impairment of GI function or GI disease that may significantly alter drug absorption
• Patient has uncontrolled or severe intercurrent medical condition (including uncontrolled brain metastases).
• Patient underwent major surgery within 4 weeks before the first dose of TVB 2640 or received cancer-directed therapy or an investigational drug or device within 4 weeks (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent (whichever is shorter) before the first dose of TVB 2640.
• If female, patient is pregnant or breast-feeding.
• Patient has evidence of a serious active infection
• Patient has a history of other malignancy treated with curative intent within the previous 5 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sagimet Biosciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey R Infante, MD

Role: PRINCIPAL_INVESTIGATOR

The Sarah Cannon Research Institute

Locations

Scottsdale, Arizona, United States

Denver, Colorado, United States

Sarasota, Florida, United States

Oklahoma City, Oklahoma, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

San Antonio, Texas, United States

Charthouse Square, London, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

West Smithfield, London, , United Kingdom

Countries

United States; United Kingdom

References

Falchook G, Infante J, Arkenau HT, Patel MR, Dean E, Borazanci E, Brenner A, Cook N, Lopez J, Pant S, Frankel A, Schmid P, Moore K, McCulloch W, Grimmer K, O'Farrell M, Kemble G, Burris H. First-in-human study of the safety, pharmacokinetics, and pharmacodynamics of first-in-class fatty acid synthase inhibitor TVB-2640 alone and with a taxane in advanced tumors. EClinicalMedicine. 2021 Mar 30;34:100797. doi: 10.1016/j.eclinm.2021.100797. eCollection 2021 Apr.

Reference Type: DERIVED

PMID: 33870151 (View on PubMed)

Other Identifiers

3V2640-CLIN-002

Identifier Type: -

Identifier Source: org_study_id