Phase I Study of MT110 in Lung Cancer (Adenocarcinoma and Small Cell), Gastric Cancer or Adenocarcinoma of the Gastro-Esophageal Junction, Colorectal Cancer, Breast Cancer, Hormone-Refractory Prostate Cancer, and Ovarian Cancer

NCT00635596 | Completed Phase 1 DMC

• 2 other identifiers: MT110-101EUDRACT No: 2007-004437-42
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 4

Brief Summary

This phase I dose escalation study is intended to define the safety, tolerability and maximal tolerable dose (MTD) of MT110 in patients with advanced solid tumors.

Conditions

Solid Tumors

Keywords

MT110; solid tumors; phase I; BiTE; bispecific T-cell engager

Outcome Measures

Primary Outcomes (1)

• Overall frequency and intensity of adverse events (AEs) (clinical symptoms, laboratory abnormalities, serious adverse events [SAEs] and dose-limiting toxicities)

  one or more treatment cycles

Secondary Outcomes (1)

• Pharmacokinetics of MT110; T-cell counts, kinetics, and activation status; Serum cytokine concentrations; Immunogenicity; Anti-tumor activity; Other progressive disease (PD) parameters

  one or more treatment cycles

Study Arms (1)

I

EXPERIMENTAL

Biological: MT110

Interventions

MT110 BIOLOGICAL

MT110 treatment as continuous intravenous infusion over at least 28 days with increasing doses

Also known as: bispecific T-cell engager (BiTE)

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced, recurrent or metastatic solid tumors known to widely express EpCAM and proven histology of the following entities:
• Adenocarcinoma of the lung
• Small cell lung cancer (SCLC)
• Gastric cancer or adenocarcinoma of gastro-esophageal junction
• Colorectal cancer (CRC)
• Hormone-refractory prostate cancer (HRPC)
• Breast cancer
• Ovarian cancer
• Patients must not be amenable to curative therapy. Patients should have exhausted or declined standard therapeutic options and previous therapies should have included at least one course of chemotherapy.
• Non-measurable disease or at least one measurable tumor lesion as per RECIST criteria
• Age \>/= 18 years
• ECOG performance status \</= 2
• Life expectancy of at least 3 months
• Must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, endocrine therapy, immunotherapy, radiotherapy or surgery.
• This generally means at least 4 weeks since major surgery, radical radiotherapy or myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin C).

You may not qualify if:

• Evidence of central nervous system (CNS) metastases on baseline computer tomography (CT) or magnetic resonance imaging (MRI) scan (mandatory for all patients), current or past relevant history of other CNS pathology (except migraine, headache and minor incidental findings in the MRI without any clinical manifestation within the last five years). All minor incidental findings should be discussed with the Sponsor's Medical Monitor).
• Neutrophil count \< 1,500/mm3 (= 1.5 x 10\^9/l)
• Platelet count \< 100,000/mm3 (= 100 x 10\^9/l)
• White blood cells (WBC) \< 3 x10\^9/l
• Hemoglobin \< 9.0 g/dl
• Abnormal renal or hepatic function as defined below:
• Alkaline phosphatase (AP)\>/= 2.5 x upper limit of normal (ULN) and/or aspartate aminotransferase (AST, SGOT), alanin aminotransferase (ALT, SGPT) \>/= 2.0 x ULN or AP, AST and/or ALT \>/= 3 x ULN in case of liver metastases; γ-glutamyl transpeptidase (GGT) \>/= 5.0 x ULN
• Total bilirubin \>/= 1.5 x ULN
• Creatinine clearance \< 50 ml/min calculated by the Cockroft-Gault formula or MDRD (modification of diet in renal disease)
• Lipase/amylase \> 1.5 x ULN
• D-dimer \>/= 10 x ULN
• Antithrombin activity \< 70%
• International normalized ratio (INR) \> ULN
• Partial thromboplastin time (PTT) \> ULN
• Oxygen (O2) saturation of \< 92% (under room air condition)

Sponsors & Collaborators

• Amgen Research (Munich) GmbH: lead

Study Sites (4)

University Hospital Freiburg Gynecological Clinic

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Hospital Kassel

Kassel, 34125, Germany

Location

University Hospital Würzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Walter Fiedler, MD, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

DE (4)