Advanced Solid TumorPhase 1NCT04990739
Study of MTB-9655, an Inhibitor of ACSS2, in Patients With Advanced Solid Tumors
A Phase 1 study testing MTB-9655 in people with Advanced Solid Tumor, run by MetaboMed Inc at 3 sites in 2 countries.
Trial summary
MetaboMed is developing MTB-9655, an orally bioavailable, first-in-class small molecule inhibitor of the human Acetyl coenzyme A (Acyl-CoA) synthetase short chain family member 2 (ACSS2) enzyme, as a potential treatment for patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- MTB-9655
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Jun 2021to 31 Jan 2024
- 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
- Signed written informed consent.
- Patient is at least 18 years-of-age at the time of signature of the informed consent form (ICF).
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Patient must have a confirmed diagnosis of locally advanced, unresectable and/or metastatic solid tumor(s), have failed standard treatment, or refuse standard treatment, or have a tumor for which no therapy of proven efficacy exists, or a tumor that is not amenable to standard therapies.
- Patient has measurable disease on imaging based or non-measurable disease.
- Patient will be requested to provide a fresh pre-treatment biopsy specimen, otherwise they are required to provide an archival diagnostic tumor sample that is <1 year old.
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- Patient has a life expectancy ≥3 months according to the Investigator's judgment.
- Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at screening within 72 hours of first dose of MTB-9655. In addition, WOCBP are required to use two forms of acceptable contraception.
- Male patients with WOCBP partners must agree to use highly effective contraceptive measures throughout the study starting with screening visit through 120 days after the last dose.
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Treatment with any of the following:
- Any systemic anti-cancer chemotherapy, small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug. At least 10 days must have elapsed between the last dose of such agent and the first dose of study drug.
- Wide-field radiotherapy administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug.
- Major surgery(excluding placement of vascular access) within 3 weeks of first dose of study drug.
- Prior treatment with other drug with the same mechanism of action (directed to ACSS2).
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- Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication for medically significant acute or chronic conditions.
- Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >1 severity that is related to prior therapy.
- Central nervous system tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to consent.
- Active infection requiring treatment.
- Out-of-range laboratory values defined as:
- Absolute neutrophil count (ANC) <1.5 × 10^9/L
- Hemoglobin <9 g/dL
- Platelets <100 × 10^9/L)
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) >2.5 × the upper limit of normal (ULN) or ≥5 × ULN with liver involvement
- Total bilirubin >1.5 × ULN
- Serum creatinine >1.5 × ULN or creatinine clearance (CrCl≤60mL/min, measured or calculated using the Cockcroft-Gault Method
- International Normalized Ratio (INR) or prothrombin time (PT) >1.5 × ULN and activated partial thromboplastin time (aPTT) >1.5 × ULN (unless patient is receiving anticoagulant therapy)
- Inability to swallow oral medications or presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of MTB-9655 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2, malabsorption syndrome).
- Any of the following cardiac criteria:
- Known history of marked prolongation of QT/corrected QT(QT/QTc) interval.
- Clinically significant cardiovascular disease, including cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure,or serious uncontrolled cardiac arrhythmia requiring medication.
- History of additional risk factors for Torsade de Pointes (including heart failure, hypokalemia, family history of long QT syndrome, and use of concomitant medications that prolong the QT/QTc interval.
- Patients with a left ventricular ejection fraction (LVEF) <50%.
- History of concomitant malignancy with recurrence <3 year from enrolment.
- Expected to require any other form of systemic or localized antineoplastic therapy while on trial.
- Significant liver cirrhosis defined as Child-Pugh Class B or C.
- History of hemolytic disorders.
- Active infection with human immunodeficiency virus (HIV).
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
- Pregnant or breastfeeding.
Trial locations and contacts
3 sites in 2 countries.
Hagop Youssoufian, MD contact
3 sites in 2 countries
Israel2 sites, 2 recruiting
- Recruiting
Rambam MC
Haifa, 31096
Ruth Perets, MD, +97244446744, ru_perets@rambam.health.gov.il
- Recruiting
Sourasky MC
Tel Aviv, 64239
Ravit Geva, MD, +97236973082, ravitg@tlvmc.gov.il
United States1 site, 1 recruiting
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Meredith McKean, MD, 615-329-7250, Meredith.McKean@SarahCannon.com
Haley Saunders, BS, Haley.Saunders@SarahCannon.com
About this study
Official title: A Phase 1 Open Label, Multicenter Study of MTB-9655, an Inhibitor of ACSS2, in Patients With Advanced Solid Tumors
MetaboMed is developing MTB-9655, an orally bioavailable, first-in-class small molecule inhibitor of the human Acetyl coenzyme A (Acyl-CoA) synthetase short chain family member 2 (ACSS2) enzyme, as a potential treatment for patients with cancer.
This study is a Phase 1,First-in-Human (FIH), open-label dose-escalation study of MTB-9655 given daily as a single oral (PO) agent. Up to 30 patients with locally advanced, unresectable and/or metastatic solid tumor(s) are expected to be enrolled in the dose-escalation portion (Part A). The study will be conducted at 1 to 2 sites in the United States and Israel.
Read the detailed description
This Phase 1 First-in-Human (FIH) study is to initiate clinical development of MTB-9655 in patients with advanced solid tumors who have failed or refused standard treatment, or who have a tumor for which no therapy of proven efficacy exists. This study of MTB-9655 may consist of 2 parts: a dose-escalation part to establish a safe and tolerable dose of MTB-9655 in patients with advanced or metastatic solid tumors for which no standard therapy is available or standard therapy has failed (Part A), and a dose expansion phase (Part B) which may be initiated at the Sponsor's discretion after the maximum tolerated dose (MTD) (or recommended Phase 2 dose [RP2D]) has been determined in the dose-escalation (Part A), and with approval of an amendment to the protocol. This study will be the basis for future studies. The study will identify the safety and tolerability of MTB-9655 when administered on a continuous dosing schedule (given by mouth on a 21-day schedule).
- Conditions
- Advanced Solid Tumor
- Being tested
- MTB-9655
- Keywords
- metastatic, ACSS2 inhibitor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTB-9655Drug
MTB-9655 is an orally available investigational product that is highly potent as it exhibits selectivity as an ACSS2 inhibitor when tested against a panel of related enzymes. MTB-9655 is formulated as a powder blend in a hydroxypropyl methylcellulose (HPMC) capsule and is presented as 25 mg and 100 mg strengths for oral administration.
Patients will receive MTB-9655, by mouth daily in 21-day treatment cycles,either 1 hour before mealtime or 2 hours after mealtime.
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose-Escalation and Part B RP2D Dose-Expansion | Experimental | Study has two parts:
1. Part A Dose-Escalation will evaluate MTB-9655 monotherapy administered in 21 days cycle,and will be conducted in 2 stages (accelerated titration and dose-escalation).
The first stage will consist of accelerated titration in single-patient cohorts for the initial two dose levels.
In the second stage, a conventional 3+3 schema using a modified Fibonacci dose titration strategy will be implemented. The first dose at every dose level and in every patient will be administered under close medical supervision, and the patients will be hospitalized for approximately 24 hours.
Up to 30 participants will participate in this dose escalation arm.
2. Part B dose-expansion will further explore the safety, PK and preliminary efficacy of MTB-9655 at the RP2D. The RP2D level will be no higher than the MTD identified in Part A. Receives: Drug: MTB-9655 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of participants with dose limiting toxicities (DLTs) from MTB-9655 monotherapy in patients with locally advanced or metastatic solid tumors.
DLTs are defined as adverse events (graded according to NCI CTCAE v5.0) during first 21 days of treatment that are related to MTB-9655 monotherapy
Measured: 21 days
Part A: Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities (DLTs) from MTB-9655 monotherapy
Measured: At the end of Cycle 1 (each cycle is 21 days)
Recommended Phase 2 dose (RP2D) of MTB-9655 monotherapy in patients with locally advanced or metastatic solid tumors.
The RP2D level will be no higher than the identified Maximum Tolerated Dose (MTD)
Measured: From Cycle 1 Day 1 until up to 30 days post last dose (each cycle is 21 days)
Number of participants with adverse events following administration of MTB-9655
Adverse events are graded according to NCI CTCAE v5.0
Measured: From Cycle 1 Day 1 until up to 30 days post last dose (each cycle is 21 days)
Secondary outcomes (6)
Pharmacokinetic Analysis single dose : maximum plasma concentration (Cmax) for MTB-9655
Blood samples will be collected for calculation of pharmacokinetic (PK) parameters.
Measured: 22 days ,from Cycle 0 to Cycle 2 Day1. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): Time to maximum plasma concentration at steady state (tmax ss) for MTB-9655
Blood samples analyzed by biochemical assays at initial dose drug levels and steady -state drug levels.
Measured: 22 days -from Cycle 0 to Cycle 2 Day1. Each cycle is 21 days.
Overall response rate in participants receiving MTB-9655
Overall response rate is defined as the proportion of patients who have a best response of either complete response (CR) or partial response (PR) based on RECIST v1.1
Measured: Every 6 weeks from Cycle 1 Day1 for 24 weeks, then every 12 weeks up to 24 months (each cycle is 21 days)
Duration of response based on RECIST 1.1
Duration of response will be defined for patients with a Best Overall Response of CR/PR as the time from the date of first documented response until date of documented progression (by RECIST v1.1), or death in the absence of disease progression.
Measured: Every 6 weeks from Cycle 1 Day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Disease control rate based on RECIST 1.1
Disease control rate is defined as the proportion of patients with CR, PR, or SD based on RECIST v1.1
Measured: Every 6 weeks from Cycle 1 Day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Progression free survival based on RECIST 1.1
Progression free survival is defined as the time from the start of study treatment until the earliest objective disease progression defined( by RECIST v1.1),or death by any cause in the absence of progression.
Measured: Every 6 weeks from Cycle 1 Day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start30 Jun 2021
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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
- Sequential
- Model description
- Initial dose escalation will use an accelerated titration scheme followed by a 3+3 dose escalation design.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetaboMed Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meredith McKean, MD, Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990739
- Sponsor's protocol ID
- MTB-9655-101
- Status last verified
- Dec 2021
- First submitted
- 8 Jul 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open Label, Multicenter Study of MTB-9655, an Inhibitor of ACSS2, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04990739
- Acronym / sponsor ID
- MTB-9655-101
- Conditions
- Advanced Solid Tumor
- Keywords
- metastatic, ACSS2 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MetaboMed IncUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 4 Aug 2021 (actual)
- 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.
MetaboMed is developing MTB-9655, an orally bioavailable, first-in-class small molecule inhibitor of the human Acetyl coenzyme A (Acyl-CoA) synthetase short chain family member 2 (ACSS2) enzyme, as a potential treatment for patients with cancer.
This study is a Phase 1,First-in-Human (FIH), open-label dose-escalation study of MTB-9655 given daily as a single oral (PO) agent. Up to 30 patients with locally advanced, unresectable and/or metastatic solid tumor(s) are expected to be enrolled in the dose-escalation portion (Part A). The study will be conducted at 1 to 2 sites in the United States and Israel.
Detailed description
This Phase 1 First-in-Human (FIH) study is to initiate clinical development of MTB-9655 in patients with advanced solid tumors who have failed or refused standard treatment, or who have a tumor for which no therapy of proven efficacy exists. This study of MTB-9655 may consist of 2 parts: a dose-escalation part to establish a safe and tolerable dose of MTB-9655 in patients with advanced or metastatic solid tumors for which no standard therapy is available or standard therapy has failed (Part A), and a dose expansion phase (Part B) which may be initiated at the Sponsor's discretion after the maximum tolerated dose (MTD) (or recommended Phase 2 dose [RP2D]) has been determined in the dose-escalation (Part A), and with approval of an amendment to the protocol. This study will be the basis for future studies. The study will identify the safety and tolerability of MTB-9655 when administered on a continuous dosing schedule (given by mouth on a 21-day schedule).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Initial dose escalation will use an accelerated titration scheme followed by a 3+3 dose escalation design.
| Arm | Type | Receives |
|---|---|---|
| Part A Dose-Escalation and Part B RP2D Dose-Expansion | Experimental | Drug: MTB-9655Study has two parts: 1. Part A Dose-Escalation will evaluate MTB-9655 monotherapy administered in 21 days cycle,and will be conducted in 2 stages (accelerated titration and dose-escalation). The first stage will consist of accelerated titration in single-patient cohorts for the initial two dose levels. In the second stage, a conventional 3+3 schema using a modified Fibonacci dose titration strategy will be implemented. The first dose at every dose level and in every patient will be administered under close medical supervision, and the patients will be hospitalized for approximately 24 hours. Up to 30 participants will participate in this dose escalation arm. 2. Part B dose-expansion will further explore the safety, PK and preliminary efficacy of MTB-9655 at the RP2D. The RP2D level will be no higher than the MTD identified in Part A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed written informed consent.
- Patient is at least 18 years-of-age at the time of signature of the informed consent form (ICF).
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Patient must have a confirmed diagnosis of locally advanced, unresectable and/or metastatic solid tumor(s), have failed standard treatment, or refuse standard treatment, or have a tumor for which no therapy of proven efficacy exists, or a tumor that is not amenable to standard therapies.
- Patient has measurable disease on imaging based or non-measurable disease.
Key exclusion criteria (31 listed)
- Treatment with any of the following:
- Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >1 severity that is related to prior therapy.
- Central nervous system tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to consent.
- Active infection requiring treatment.
- Out-of-range laboratory values defined as:
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 |
|---|---|---|
| MTB-9655MTB-9655 is an orally available investigational product that is highly potent as it exhibits selectivity as an ACSS2 inhibitor when tested against a panel of related enzymes. MTB-9655 is formulated as a powder blend in a hydroxypropyl methylcellulose (HPMC) capsule and is presented as 25 mg and 100 mg strengths for oral administration. Patients will receive MTB-9655, by mouth daily in 21-day treatment cycles,either 1 hour before mealtime or 2 hours after mealtime. | Drug | Part A Dose-Escalation and Part B RP2D Dose-Expansion |
Primary outcome
Part A: Number of participants with dose limiting toxicities (DLTs) from MTB-9655 monotherapy in patients with locally advanced or metastatic solid tumors.
Time frame: 21 days
DLTs are defined as adverse events (graded according to NCI CTCAE v5.0) during first 21 days of treatment that are related to MTB-9655 monotherapy
Part A: Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities (DLTs) from MTB-9655 monotherapy
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Recommended Phase 2 dose (RP2D) of MTB-9655 monotherapy in patients with locally advanced or metastatic solid tumors.
Time frame: From Cycle 1 Day 1 until up to 30 days post last dose (each cycle is 21 days)
The RP2D level will be no higher than the identified Maximum Tolerated Dose (MTD)
Number of participants with adverse events following administration of MTB-9655
Time frame: From Cycle 1 Day 1 until up to 30 days post last dose (each cycle is 21 days)
Adverse events are graded according to NCI CTCAE v5.0
6 secondary outcomes
Pharmacokinetic Analysis single dose : maximum plasma concentration (Cmax) for MTB-9655
Time frame: 22 days ,from Cycle 0 to Cycle 2 Day1. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): Time to maximum plasma concentration at steady state (tmax ss) for MTB-9655
Time frame: 22 days -from Cycle 0 to Cycle 2 Day1. Each cycle is 21 days.
Overall response rate in participants receiving MTB-9655
Time frame: Every 6 weeks from Cycle 1 Day1 for 24 weeks, then every 12 weeks up to 24 months (each cycle is 21 days)
Duration of response based on RECIST 1.1
Time frame: Every 6 weeks from Cycle 1 Day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Disease control rate based on RECIST 1.1
Time frame: Every 6 weeks from Cycle 1 Day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Progression free survival based on RECIST 1.1
Time frame: Every 6 weeks from Cycle 1 Day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Hagop Youssoufian, MD contact
Meredith McKean, MD study chair
SCRI Development Innovations, LLC
3 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 MTB-9655 in people with Advanced Solid Tumor, run by MetaboMed Inc at 3 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 9 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Cannon Development Innovations (844-710-6157, CANN.InnovationsMedical@sarahcannon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of participants with dose limiting toxicities (DLTs) from MTB-9655 monotherapy in patients with locally advanced or metastatic solid tumors. (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2021.