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Neoplasm MetastasisPhase 1XMT-1107NCT01011972

A Study of Intravenous XMT-1107 in Patients With Advanced Solid Tumors

A Phase 1 study testing XMT-1107 in people with Neoplasm Metastasis, run by Mersana Therapeutics at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

XMT-1107 has been shown in nonclinical studies to slow the growth of tumors. These effects may result from blocking the growth of new blood vessels that help the tumors survive. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm Metastasis
What is being tested?
XMT-1107
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
4 sitesUnited States
Study dates
Mar 2010to Sep 2013
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 must have a histological diagnosis of advanced solid tumor and must be refractory to standard therapy or have no effective therapy.
  • Measurable or evaluable disease.
  • At least 42 days since administration of mitomycin or nitrosoureas and 28 days since any other chemotherapy, investigational agent, and/or radiation therapy.
  • Age ≥ 18 years old.
  • Have the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
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  • Platelet count ≥ 100,000 cells/mm3
  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min (Calculated by Cockroft and Gault method. Creatinine clearance (mL/min) = (140-age) x weight (kg)/72 x (serum creatinine in mg/dL) = ml/min (for females, multiply results by 0.85))
  • Total bilirubin ≤ 1.5 mg/dL or ≤ upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the institutional upper limit of normal (ULN) or ≤ 5 times ULN of liver metastases are present
  • Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 times the ULN
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
  • Life expectancy of at least 3 months.
  • Signed informed written consent.

Who cannot join

  • Known brain metastases (either currently or previously).
  • Peripheral neuropathy ≥ Grade 2.
  • Ataxia ≥ Grade 1.
  • Cognitive disturbance ≥ Grade 1.
  • History of seizures.
  • Patients known to be human immunodeficiency virus (HIV) positive.
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  • Active infections requiring IV antibiotics or serious intercurrent illness, including hepatitis B or C.
  • Unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening arrhythmia.
  • Known hypersensitivity to this class of drugs.
  • Pregnant or nursing women, women who are of childbearing potential and are not using an effective method of either barrier or hormonal contraceptives. Men who are not using an effective method of barrier contraceptive, or who would not be willing to continue to use these effective methods for the duration of the study.
  • Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury ≤ 4 weeks prior to beginning treatment.
  • Patients with proteinuria at screening as demonstrated by either:
  • urine protein creatinine (UPC) ratio ≥ 1.0 at screening OR
  • urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection, and must demonstrate ≤ 1 g of protein/24 hours to be eligible)
  • Patients with a serious non-healing wound, active ulcer, or untreated bone fracture.
  • Patients with history of hematemesis or hemoptysis (defined as having bright red blood of ½ teaspoon or more per episode) ≤ 1 month prior to study enrollment.
  • Inadequately controlled hypertension (defined as systolic blood pressure >140 mm Hg and/or diastolic blood pressure > 90 mm Hg while on antihypertensive medications). Initiation of antihypertensive agents is permitted provided adequate control is documented at least 1 week prior to beginning study treatment.
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) ≤ 6 months prior to Day 1 of treatment.
  • History of stroke or transient ischemic attack ≤ 6 months prior to beginning treatment.
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • History of abdominal fistula or gastrointestinal perforation ≤ 6 months prior to Day 1 of beginning treatment.
  • QTc interval > 470 milliseconds as calculated by Bazett's formula.
  • Any issue that, in the opinion of the Investigator, would render the patient unsuitable for study participation.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of MD Greenbaum Cancer Center

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

  • Sarah Cannon Research Institute (SCRI)

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: A Phase 1 Study of the Safety and Pharmacokinetics of XMT-1107 Administered as an Intravenous Infusion Once Every Three Weeks to Patients With Advanced Solid Tumors

XMT-1107 has been shown in nonclinical studies to slow the growth of tumors. These effects may result from blocking the growth of new blood vessels that help the tumors survive.

Read the detailed description

This is an open-label, ascending-dose study of XMT-1107 administered intravenously over 90 minutes every 21 days (1 cycle). Blood sampling for PK analyses will be performed immediately prior to dosing and after dosing. Adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 4.0 (CTCAE v4.0)

Being tested
XMT-1107
Keywords
Dose escalation, XMT-1107, 1107, Tumor, Phase 1, Fumagillol, PHF, Fleximer, cancer, maximum tolerated dose, MTD
Medical subject headings
Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XMT-1107Drug

    Also called conjugated XMT-1191

    6 mg XMT-1107 administered by I.V. (in the vein) administered over 90 min, once every 21 days : until progression or unacceptable toxicity develops

Study groups in NCT01011972
Study groupRoleWhat they receive
XMT-1107ExperimentalDose escalation groups of XMT-1107, I.V. (in the arm) beginning at 6 mg/m^2, doubling in dose to 24 mg/m^2, then 40 mg/m^2, then 60 mg/m^2, then 80 mg/m^2 with subsequent doses at 33% of the previous until disease progression or unacceptable side effects are experienced.
Receives: Drug: XMT-1107

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary objective of this study is to determine the maximum tolerated dose of XMT-1107 when given via IV once every three weeks.

    Measured: Adverse events are assessed during each treatment cycle.

Secondary outcomes (5)

  1. Assess the pharmacokinetics (PK) of XMT-1107 and its release product

    Measured: Samples for PK are collected during Cycle 1 and prior to each subsequent treatment cycle

  2. Determine the recommended Phase 2 dose of XMT-1107

    Measured: Throughout Cycle 1

  3. Assess the safety of XMT-1107.

    Measured: Throughout Cycle 1

  4. Observe for evidence of anti-tumor activity by XMT-1107.

    Measured: Course of study

  5. Monitor the effect of XMT-1107 on MetAP2 inhibition in leukocytes from patients

    Measured: Cycle 1 and Cycle 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01011972
Sponsor's protocol ID
MER-1107-001
Acronym
XMT-1107
Status last verified
Sep 2016
First submitted
10 Nov 2009
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XMT-1107 in people with Neoplasm Metastasis, run by Mersana Therapeutics at 4 sites in United States.

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 15 inclusion and 23 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in 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?

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?

The primary objective of this study is to determine the maximum tolerated dose of XMT-1107 when given via IV once every three weeks. (time frame: Adverse events are assessed during each treatment cycle.). 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 NCT01011972.

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 31 Jan 2018.

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