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A Phase 1 Study of IMC-11F8 in Patients With Advanced Solid Tumors

Phase 1
20 Years
Not Enrolling
Advanced Solid Tumors

Thank you

Trial Information

A Phase 1 Study of IMC-11F8 in Patients With Advanced Solid Tumors

This single center, open-label, single-arm, Phase 1 study will enroll 18 patients at a
maximum. The actual size will vary depending on the dose-limiting toxicities (DLTs) observed
and the resultant sizes of the cohorts. Patients will receive IMC-11F8 administered
intravenously, once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle).
All infusions can be administered within ± 1 day of the scheduled administration date.
After one cycle of treatment, patients who have an objective response or stable disease may
continue to receive IMC-11F8 at the same dose and schedule until disease progression or
other withdrawal criteria are met.

A minimum of three patients will be enrolled in each cohort. Dose escalation in successive
cohorts will occur once all patients complete one cycle of therapy.

Patients will be enrolled sequentially into each cohort. A completed patient will be either
a patient who completes the initial 6 week treatment period (Cycle 1) or a patient who
discontinues therapy for an IMC-11F8-related toxicity during Cycle 1. Patients who do not
complete the first 6 weeks of treatment for reasons other than an IMC-11F8-related toxicity
will be replaced. Toxicity data for each cohort will be reviewed prior to dose escalation.
Upon completion of all required safety evaluations during the initial 6 weeks, the next
cohort of new patients will be treated at the next higher dose level using a dose escalation

Inclusion Criteria:

- Solid tumor patient who has been histopathologically or cytologically documented

- Advanced primary or recurrent solid tumors patient who has not responded to standard
therapy or for whom no standard therapy is available

- The patient has measurable or nonmeasurable lesions according to Response Evaluation
Criteria in Solid Tumors (RECIST) Version 1.0 guidelines

- The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS)
score of 0-1 at study entry

- The patient is able to provide written informed consent

- The patient is age 20 years or older

- The patient has a life expectancy of > 3 months

- The patient has adequate hematologic function

- The patient has adequate renal function

- The patient agrees to use adequate contraception for the duration of study
participation and for at least 12 weeks after the last dose of study therapy

- The patient has adequate recovery from recent surgery, chemotherapy, and radiation
therapy (including palliative radiation therapy). At least 28 days (6 weeks for
nitrosoureas or mitomycin C) must have elapsed from major surgery, prior
chemotherapy, prior treatment with an investigational agent or device, or prior
radiation therapy. For treatment with nonapproved monoclonal antibodies, a minimum of
8 weeks must have elapsed

- The patient is willing to comply with study procedures until the End-of-Therapy visit

Exclusion Criteria:

- The patient has received chemotherapy or therapeutic radiotherapy within 28 days (6
weeks for nitrosoureas or mitomycin C) prior to entering the study, or the patient
has ongoing side effects ≥ Grade 2 due to agents administered more than 28 days
earlier (except alopecia)

- The patient has documented and/or symptomatic brain or leptomeningeal metastases
(patients who are clinically stable [no symptoms during the 4 weeks prior to
enrollment] with an assessment that no further treatment [radiation, surgical
excision, or administration of steroids] is required are permitted to enter the

- The patient has an uncontrolled intercurrent illness including, but not limited to:

- Ongoing or active infection requiring systemic antibiotic treatment

- Congestive heart failure (Class III or IV per the New York Heart Association
heart disease classification guidelines)

- The patient has participated in clinical studies of nonapproved experimental agents
or procedures within 4 weeks prior to first dose of study therapy, or within 8 weeks
prior to first dose of study therapy for nonapproved monoclonal antibodies

- The patient has received any previous treatment with monoclonal antibodies targeting
the EGFR. Previous treatment with EGFR tyrosine kinase inhibitors, approved or
nonapproved, is allowed. There must be a time interval of at least 4 weeks between
the last EGFR TKI dose and the first dose of IMC-11F8

- The patient has acute or subacute intestinal occlusion/obstruction

- The patient has a history of inflammatory bowel disease (eg, Crohn's disease,
ulcerative colitis) requiring medical intervention in the three years prior to study

- The patient has acute pulmonary disorder, interstitial pneumonia, pulmonary fibrosis,
or history thereof

- The patient has a known allergy to any of the treatment components, or to monoclonal
antibodies or other therapeutic proteins such as fresh frozen plasma, human serum
albumin, cytokines, or interleukins. In the event that there is suspicion that the
patient may have allergies, the patient should be excluded

- The patient, if female, is pregnant (confirmed by urine or serum pregnancy test) or

- The patient has known alcohol or drug dependency

- The patient is HBV antigen, HCV antibody, or HIV antibody positive

- The patient is assessed as inadequate for the study by the investigator

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Summary Listing of Participants Reporting Treatment-Emergent Adverse Events

Outcome Time Frame:

10 months

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

January 2010

Completion Date:

February 2012

Related Keywords:

  • Advanced Solid Tumors
  • Human IgG1 MAb, EGFR, solid tumour,
  • Neoplasms