Open Label, Dose Escalating Study With Ertumaxomab In Patients With HER-2/Neu Expressing Advanced Solid Tumors

NCT01569412 | Terminated Phase 1

• 1 other identifier: ERTUSO
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with HER2/neu expressing solid tumors progressing after standard therapy will be treated with a so called trifunctional antibody (Ertumaxomab). The main objective of this trial is to find the maximum tolerated dose. Tolerability and Safety will be assessed as well as efficacy.

Conditions

Her2/Neu Positive Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose

  every week until end of treatment (max. 108 days)

Secondary Outcomes (3)

• Pharmacodynamic

  weekly until end of treatment (max. 108 days)

• efficacy according to RECIST and immune related response criteria (irRC)

  every 6 weeks until progression of disease

• adverse events

  weekly (max 108 days)

Study Arms (1)

Ertumaxomab

EXPERIMENTAL

Ertumaxomab administration during two treatment cycles will follow a predefined dose escalation scheme, consisting of 5 ascending doses per cycle with each infusion lasting 3 hours.

Biological: Ertumaxomab

Interventions

Ertumaxomab BIOLOGICAL

trifunctional antibody, infusion i.v., increasing doses, up to 10 infusions

Ertumaxomab

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent form.
• Male or female patients aged ≥ 18 years and with a life expectancy of at least 4 months.
• Negative pregnancy test at screening (and not more than 72 hours prior to the first ertumaxomab infusion) for women of childbearing potential. Patients must agree to use adequate contraception during the study.
• Measurable disease, defined as at least one lesion that is measurable in one dimension.
• Solid HER2/neu positive tumors (1+/SISH positive, 2+, and 3+), histologically confirmed.
• Patients must have disease progression during or after standard therapy and/or are no longer feasible for approved therapies.
• Previous therapies must be discontinued at least 2 weeks (6 weeks in case mitomycin C) prior to administration of ertumaxomab and all treatment related toxicities must have resolved or decreased to common toxicity criteria (CTC) grade 1 (with the exception of alopecia and peripheral neuropathy).
• If patients have received HER2-targeting therapies, all HER2-targeting therapies must have been discontinued before study entry.
• Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
• Adequate hematological, liver and kidney function:
• Adequate recovery from prior systemic therapy.
• Patients capable to understand the purposes and risks of the study, and who are willing and able to participate in the study
• Left ventricular ejection fraction must be \> 50% at echocardiography

You may not qualify if:

• Patients currently being treated with medication or anticonvulsants for brain or central nervous system metastases or patients that have documented radiologic evidence of active brain or central nervous system metastases within 12 weeks of study entry.
• Patients with a prior diagnosis of any other malignancy (unless cured by surgery or other appropriate treatments greater than 2 years before study entry). Patients with in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin may be included at any time.
• ≥ 5 preceding chemotherapies
• Documented acute or chronic infection or other concurrent non-malignant co morbidities that are uncontrolled, such as unstable or uncontrolled pectorial angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis or congestive heart failure (CHF, NYHA III or IV).
• Patients with a known human immunodeficiency virus, hepatitis B or hepatitis C positive status are excluded from participation in the study
• Any concurrent chemotherapy, radiotherapy (except for local radiation therapy for bone marrow metastasis), hormonal therapy, immunotherapy or corticoid therapy.
• Treatment with any investigational product within 2 weeks prior to first administration of ertumaxomab.
• Patients with documented autoimmune diseases.
• Known hypersensitivity to murine proteins and any other component of the drug.
• Abnormal organ or bone marrow function as defined below (any single parameter to fulfill condition):
• ANC \< 1.5 Gpt/l (1.5x109/L, 1500/mm3)
• Hemoglobin \<9.0 g/dl
• Platelet count \< 75Gpt/l (75x109/L, 75,000/mm³)
• AST(SGOT)/ALT(SGPT) \> 3 x upper limit of normal (ULN); or: in case of metastatic liver disease AST(SGOT)/ALT(SGPT) \> 5 x ULN
• Alkaline Phospatase \> 2.5 x ULN

Sponsors & Collaborators

• Krankenhaus Nordwest: lead

Study Sites (1)

Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany

Location

Related Publications (1)

• Haense N, Atmaca A, Pauligk C, Steinmetz K, Marme F, Haag GM, Rieger M, Ottmann OG, Ruf P, Lindhofer H, Al-Batran SE. A phase I trial of the trifunctional anti Her2 x anti CD3 antibody ertumaxomab in patients with advanced solid tumors. BMC Cancer. 2016 Jul 7;16:420. doi: 10.1186/s12885-016-2449-0.

  PMID: 27387446 DERIVED

MeSH Terms

Interventions

ertumaxomab

Study Officials

• Salah-Eddin Al-Batran, MD

  Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: April 3, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

DE (1)