Solid Malignant TumorPhase 1NCT02223247
A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors
A Phase 1 study testing TVB-2640 in people with Solid Malignant Tumor, run by Sagimet Biosciences Inc. at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Malignant Tumor
- What is being tested?
- TVB-2640
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Nov 2013to Jun 2017
- 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
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States7 sites
Study site
Dallas, Texas, 75390
Study site
Denver, Colorado, 80218
Study site
Nashville, Tennessee, 37203
Study site
Oklahoma City, Oklahoma, 73104
Study site
San Antonio, Texas, 78229
Study site
Sarasota, Florida, 34232
Study site
Scottsdale, Arizona, 85258
United Kingdom4 sites
Study site
Charthouse Square, London
Study site
London, W1G 6AD
Study site
Manchester
Study site
West Smithfield, London
About this study
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
- Being tested
- TVB-2640
- Keywords
- solid tumors, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVB-2640Drug
| Study group | Role | What they receive |
|---|---|---|
| TVB-2640 | Experimental | 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 Receives: Drug: TVB-2640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) based on toxicity analysis.
Toxicity will be monitored according to NCI - Common Toxicity Criteria for Adverse Events version (4.03). Patients receiving at least one dose of drug.
Measured: 1.5 years
To determine the incidence and nature of dose-limiting toxicities (DLTs) of TVB-2640.
Measured: Days 1 to 21 of cycle 1 for monotherapy cohort(s); Days 1 to 28 of cycle 1 for combination with anti-cancer agent cohort(s)
Secondary outcomes (3)
Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03).
Measured: Up to 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first.
Pharmacokinetic parameters of TVB-2640 (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state)
Cmax, Cmin, Tmax, AUC and Half-life of TVB-2640
Measured: At Cycle Day 1, 2, 8, 15, (and 22 for combination cohorts) then the first day of subsequent cycles until discontinuation.
Tumor response per RECIST 1.1
Measured: Measured every 6 weeks for 21 day cycles or every 8 weeks for 28 day cycles for the duration of study treatment, estimated to be less than one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sagimet Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Infante, MD, Principal investigator, The Sarah Cannon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223247
- Sponsor's protocol ID
- 3V2640-CLIN-002
- Status last verified
- Aug 2017
- First submitted
- 18 Aug 2014
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33870151
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02223247
- Acronym / sponsor ID
- 3V2640-CLIN-002
- Conditions
- Solid Malignant Tumor
- Keywords
- solid tumors, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sagimet Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TVB-2640 | Experimental | Drug: TVB-2640Oral 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVB-2640 | Drug | TVB-2640 |
Primary outcome
To determine the maximum tolerated dose (MTD) based on toxicity analysis.
Time frame: 1.5 years
Toxicity will be monitored according to NCI - Common Toxicity Criteria for Adverse Events version (4.03). Patients receiving at least one dose of drug.
To determine the incidence and nature of dose-limiting toxicities (DLTs) of TVB-2640.
Time frame: Days 1 to 21 of cycle 1 for monotherapy cohort(s); Days 1 to 28 of cycle 1 for combination with anti-cancer agent cohort(s)
3 secondary outcomes
Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03).
Time frame: Up to 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first.
Pharmacokinetic parameters of TVB-2640 (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state)
Time frame: At Cycle Day 1, 2, 8, 15, (and 22 for combination cohorts) then the first day of subsequent cycles until discontinuation.
Tumor response per RECIST 1.1
Time frame: Measured every 6 weeks for 21 day cycles or every 8 weeks for 28 day cycles for the duration of study treatment, estimated to be less than one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Derived from this study: PubMed 33870151Falchook 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey R Infante, MD principal investigator
The Sarah Cannon Research Institute
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TVB-2640 in people with Solid Malignant Tumor, run by Sagimet Biosciences Inc. at 11 sites in 2 countries.
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 13 inclusion and 6 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 14 Aug 2017. 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, United Kingdom. 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?
To determine the maximum tolerated dose (MTD) based on toxicity analysis. (time frame: 1.5 years). The study lists 2 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 NCT02223247, which also lists 1 linked publication.
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 14 Aug 2017.