Trial record 2 of 3 for:    LUNG IMGN901

BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346385
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
ImmunoGen, Inc.

June 28, 2006
June 29, 2006
March 26, 2015
March 2002
October 2011   (Final data collection date for primary outcome measure)
Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments [ Time Frame: these tests will be conducted at various timepoints during a patients participation in the trial ]
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Complete list of historical versions of study NCT00346385 on Archive Site
  • Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level [ Time Frame: PK is assessed during the first cycle (21 days) of a patients participation ]
  • Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM) [ Time Frame: efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle ]
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BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901

RATIONALE: Monoclonal antibodies, such as BB-10901, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed or refractory solid tumors.



  • Determine the safety and tolerability of BB-10901
  • Determine the maximum tolerated dose of this drug in these patients.


  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the efficacy of this drug in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study.

Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.* Treatment repeats every 21 days

NOTE: *Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the independent Safety Review Board.

Cohorts of 4-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4-6 patients experience dose-limiting toxicity in course 1. Up to 40 patients are treated at the MTD.

After completion of study treatment, patients are followed for short term and long term follow up and survival.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued to this study.

Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ovarian Cancer
  • Merkel Cell Carcinoma
  • SCLC
Drug: BB-10901
dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.
Other Name: IMGN901
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2011
October 2011   (Final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed diagnosis of 1 of the following:

    • Small cell lung cancer (SCLC)
    • Other pulmonary tumors of neuroendocrine origin, including neuroendocrine carcinoma or non-SCLC with neuroendocrine features
    • Non-pulmonary small cell carcinoma
    • Metastatic carcinoid tumor
    • Other CD56-positive solid tumor
  • Diagnoses other than SCLC must have confirmation of tumor CD56 expression before study entry
  • Relapsed or refractory disease
  • Must have received at least 1 but no more than 3 prior chemotherapy regimens* and recovered from any acute toxicities

    • No prior chemotherapy for carcinoid or neuroendocrine tumors


  • Relapsed or refractory Small cell lung cancer (SCLC)
  • Metastatic Merkel Cell carcinomas
  • Ovarian carcinomas

At the MTD:

SCLC patients must have received one, but no more than 1 prior chemotherapy regimen Merkel and Ovarian patients must have received at least one prior chemotherapy regimen. Ovarian patients must have received at least one platinum-based regimen.

  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, labile blood pressure)
  • No active brain metastases; no evidence of active disease and no requirement for anticonvulsant medications or steroids.


  • Life expectancy ≥ 3 months
  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Bilirubin ≤ 3 times ULN
  • No rapidly rising liver function tests (LFTs)
  • Pancreatic function, amylase and lipase within upper limit of normal.
  • No significant residual neurological or cardiac toxicity ≥ grade 2 after prior chemotherapy
  • No myocardial infarction within the past 6 months
  • No unstable angina pectoris
  • No uncontrolled congestive heart failure
  • No uncontrolled arrhythmia
  • No severe aortic stenosis
  • No history of multiple sclerosis or other demyelinating disease
  • No Eaton-Lambert syndrome (para-neoplastic syndrome)
  • No history of hemorrhagic stroke
  • No CNS injury with residual neurologic deficit
  • No ischemic stroke within the past 6 months
  • No history of pancreatitis
  • No current active infection or history of recurrent infection with varicella-zoster virus (shingles) or cytomegalovirus
  • No other concurrent serious infection
  • No chronic alcoholism
  • No other concurrent illness or condition that would interfere with study outcome
  • No other malignancy within the past 3 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  • No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas


  • See Disease Characteristics
  • Total cumulative dosage of prior anthracycline treatment must not exceed threshold for cardiotoxicity
  • No known hypersensitivity to previous monoclonal antibody therapy
  • More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
  • More than 4 weeks since prior and no other concurrent investigational agents
  • At least 4 weeks since prior and no concurrent surgery
  • No other concurrent antineoplastic treatment, including immunotherapy or steroid therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
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ImmunoGen, Inc.
ImmunoGen, Inc.
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Study Chair: Paul C. Lorigan, MD The Christie NHS Foundation Trust
ImmunoGen, Inc.
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP