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Breast CancerPhase 1NCT02045368

Study of Insulin-like Growth Factor (IGF)-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R

A Phase 1 study testing IGF-Methotrexate conjugate in people with Breast Cancer and Brain Cancer, run by IGF Oncology, LLC at 1 site 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

This phase I dose escalation study will evaluate IGF-Methotrexate conjugate (765IGF-MTX) in patients with advanced, previously treated tumors. 765IGF-MTX is administered as an IV infusion over 1 hour on days 1, 8 and 15 of a 28 day cycle. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IGF-Methotrexate conjugate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteUnited States
Study dates
28 Jan 2014to 30 Sep 2016
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

  • Diagnosis of advanced malignancy, refractory to or intolerant to standard therapy and is no longer likely to respond to such therapy.
  • Tumor (tissue, bone marrow, or blood) must express IGF-1R, defined as 10% or higher of cells expressing IGF-1R by immuno-histochemistry (IHC), or 0.1% or higher for IGF-1R expression by flow cytometry (blood or bone marrow aspirate).
  • Paraffin-embedded tissue sections will be stained with antibodies against insulin-like growth factor receptor 1 (IGFR-1) according to the manufacturer's recommended protocols. IHC staining and flow cytometry will be performed at the Pathology Department of the University of Illinois Cancer Center.
  • Measurable or evaluable disease per RECIST 1.1 criteria for solid tumors and lymphoma as defined in the protocol. For other hematologic malignancies, see below (measurable disease per RECIST 1.1 criteria not necessary).
  • Multiple Myeloma: Confirmed diagnosis of multiple myeloma as defined in the protocol with relapsed or refractory disease, and measurable disease defined as one of below:
  • Serum monoclonal protein > 500mg/dL by serum protein electrophoresis (SPEP)
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  • Urine monoclonal protein > 200mg/24 hours by urine protein electrophoresis (UPEP)
  • Measurable free light chain by free light chain assay > 10mg/dL with abnormal kappa to lambda light chain ratio
  • Measurable bone disease by > 1 bone lesion which is > 20 mm on conventional techniques or > 10 mm with spiral CT (for lytic lesions)
  • Monoclonal bone marrow plasmacytosis > 30%
  • Lymphoma: Previously treated, histologically confirmed lymphoma with measurable disease via RECIST 1.1, with the exception of lymphoplasmacytic lymphoma, which can be diagnosed based on morphologic evidence in the bone marrow plus the appropriate paraprotein.
  • Waldenstrom's Macroglobulinemia: Confirmed diagnosis with relapsed or refractory disease, and measurable disease defined as at least one lesion with a single diameter of greater than 2cm by CT or bone marrow involvement with greater than 10% malignant cells and immunoglobulin (IgM, IgG, IgA) greater than 1000mg/dL.
  • Hematologic malignancies including myelodysplastic syndrome(MDS), leukemia: Confirmed histologic diagnosis with relapsed or refractory disease; measurable disease per RECIST 1.1 criteria is not required.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Prior systemic chemotherapy, immunotherapy, or biological therapy, radiation therapy and/or surgery are allowed; however prior use of methotrexate allowed if > 6 months prior to study entry. Intrathecal methotrexate is allowed prior to and during treatment per investigator discretion. Time since prior therapy and the first dose of study drug:
  • At least 2 weeks since prior radiation, non cytotoxic small molecule drugs (e.g., tyrosine kinase inhibitors such as erlotinib and hormonal agents such as letrozole), prior major surgery (surgery defined as a surgery involving a risk to the life of the patient; specifically: an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity), prior systemic FDA approved therapy
  • At least 3 weeks since prior antineoplastic therapy
  • At least 4 weeks since exposure to monoclonal antibodies (chimeric or fully human)
  • At least 6 weeks since prior nitrosureas or mitomycin-C
  • Patient must have recovered from the acute toxic effects (≤ grade 1 CTCAE v.4.0) of previous anti-cancer treatment prior to study enrollment; the only exception is that grade 2 neuropathy is permitted
  • Adequate organ function within 14 days of study registration defined as the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1.5 X 10^9/L
  • Hemoglobin ≥ 9g/dL* (Patient may not have had a transfusion within 7 days of blood draw.)
  • Platelets ≥ 100 X 10^9/L* (Patient may not have had a transfusion within 7 days of blood draw.)
  • Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
  • Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 X ULN < 5 X ULN is acceptable if liver has tumor involvement)
  • Serum creatinine ≤ 1.5 X ULN
  • Creatinine clearance ≥ 60 ml/min^2 or glomerular filtration rate (GFR) ≥ 60 ml/min^2 or 24 hour urine creatinine clearance ≥ 50 ml/min
  • Laboratory values for lymphoma patients:
  • Absolute neutrophil count (ANC) ≥ 1.0 X 10^9/L
  • Hemoglobin ≥ 8g/dL
  • Platelets ≥ 50 X 10^9/L
  • Total bilirubin ≤ 1.5 X ULN
  • Alkaline phosphatase, AST and ALT ≤ 3 X ULN (< 5 X ULN is acceptable if liver has tumor involvement)
  • Serum creatinine ≤ 1.5 X ULN
  • Creatinine clearance ≥ 60 ml/min^2 or GFR ≥ 60 ml/min^2 or 24 hour urine creatinine clearance ≥ 50 ml/min
  • Negative urine or serum pregnancy test in females. Male and female patients with reproductive potential must use an approved contraceptive method if appropriate (for example, abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier methods) during and for 3 months after the last dose of 765IGF-MTX.
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

Who cannot join

  • Untreated central nervous system (CNS) metastases
  • Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
  • ≥ Grade 3 peripheral neuropathy within 14 days before enrollment.
  • Systemic infection requiring IV antibiotic therapy within 7 days preceding the first dose of study drug, or other severe infection.
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Pregnant or breastfeeding - methotrexate is Pregnancy Category X - has been reported to cause fetal death and/or congenital abnormalities. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
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  • Uncontrolled diabetes mellitus defined as a Hemoglobin A1C≥ 7% in patients with a prior history of diabetes, 28 days prior to study enrollment.
  • Serious concomitant systemic disorders (e.g., active infection, uncontrolled diabetes) or psychiatric disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
  • Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.
  • Recent (within 6 months) arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI).
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
  • Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinical significant.
  • History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anticoagulants for at least 6 weeks are eligible.
  • Presence of any non-healing wound, fracture, or ulcer within 28 days prior to the first dose of study drug.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to IGF or methotrexate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: STM-02: Phase I Study of IGF-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing Insulin-like Growth Factor Receptor 1 (IGF-1R)

This phase I dose escalation study will evaluate IGF-Methotrexate conjugate (765IGF-MTX) in patients with advanced, previously treated tumors. 765IGF-MTX is administered as an IV infusion over 1 hour on days 1, 8 and 15 of a 28 day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient refusal. Assessment of response will be confirmed with imaging studies performed at the end of cycle 2 +/- 7 days, and every 2 weeks thereafter.

Being tested
IGF-Methotrexate conjugate
Keywords
refractory, intolerant, solid tumors
Medical subject headings
Breast Neoplasms, Brain Neoplasms, Gastrointestinal Neoplasms, Urogenital Neoplasms, Head and Neck Neoplasms, Melanoma

What participants receive

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

  • IGF-Methotrexate conjugateDrug

    Also called 765IGF-MTX

    IV infusion at the assigned dose administered on days 1, 8, and 15 of a 28 day (4 week) cycle. Up to 7 dose levels will be tested, starting with 0.05 microequivalents per kg and up to 2.5 microequivalents per kg.

Study groups in NCT02045368
Study groupRoleWhat they receive
Subject Treatment with IGF-Methotrexate conjugateExperimentalIV infusion at the assigned dose administered on days 1, 8, and 15 of a 28 day (4 week) cycle.
Receives: Drug: IGF-Methotrexate conjugate

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    The primary objective is to determine the maximum tolerated dose (MTD) of 765IGF-MTX by evaluation of toxicity for the treatment of advanced, previously treated malignancies that express IGF-1R.

    Measured: Up to 30 days after final dose.

Secondary outcomes (2)

  1. Adverse Effects

    Characterize adverse effects (AE) of 765IGF-MTX in patients with advanced, previously treated malignancies as defined by CTCAE v 4.0.

    Measured: Up to 30 days after last dose study drug.

  2. Disease Response based on RECIST Criteria

    Evaluate clinical response of 765IGF-MTX in patients with advanced, previously treated malignancies. Disease response will be assessed every 8 weeks while on study treatment using the Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).

    Measured: Up to 8 weeks after last dose study drug.

Timeline

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

  1. First posted24 Jan 2014 (estimated)
  2. Study start28 Jan 2014
  3. Primary completion30 Sep 2016
  4. Study completion30 Sep 2016

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
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02045368
Sponsor's protocol ID
STM-02
Other IDs
2013-0655
Status last verified
Aug 2019
First submitted
15 Jan 2014
Last updated
22 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IGF-Methotrexate conjugate in people with Breast Cancer and Brain Cancer, run by IGF Oncology, LLC at 1 site 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 39 inclusion and 15 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 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Maximum Tolerated Dose (MTD) (time frame: Up to 30 days after final dose.). 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 NCT02045368.

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 22 Aug 2019.

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