An open-label, two-stage Phase I/IIa dose escalation study of BT062 in metastatic triple receptor-negative breast cancer and in metastatic transitional cell carcinoma of the urinary bladder - INTRAIN-BB (INdaTuximab RAvtansin effect IN Breast and Bladder cancer)

Biotest AG0 sites180 target enrollmentSeptember 13, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Subjects with metastatic triple receptor-negative breast cancer (TNBC) who failed at least 2 and no more than 4 prior chemotherapies or alternativelySubjects with metastatic transitional cell carcinoma (TCC) of the urinary bladder who failed at least 1 and no more than 2 prior chemotherapies.
Sponsor: Biotest AG
Enrollment: 180
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

September 13, 2013

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Signed written Informed Consent Form in accordance with institutional guidelines and applicable national law, prior to any study\-related procedure;
•2\. Diagnosis:
•metastatic triple\-negative breast cancer with histochemical confirmation of the absence of progesterone receptors, estrogen receptors and human epidermal growth factor receptors
•metastatic transitional celll carcinoma of the urinary bladder
•3\. Relapsed or relapsed / refractory disease at a stage that cannot be controlled adequately by surgery, radiotherapy or standard chemotherapy;
•3a: Patients presenting with triple negative breast cancer and who failed at least 2, but not more than 4 previous chemotherapy / drug therapy regimens. In patients who failed more than 2 prior chemotherapy / drug therapy regimens, the last progression of disease must not have been observed earlier than within 9 weeks of the start of the treatment.
•3b: Patients presenting with urinary bladder cancer and who failed at least 1, but not more than 2 previous chemotherapy regimens.
•4\. Measurable disease according to the RECIST (v1\.1\) with at least one measurable lesion and at least one tumor biopsy with histologically confirmed malignancy;
•5\. Histological confirmation of moderate to high CD138 expression for at least one lesion;
•6\. Female or male patients aged \> 18 years;

•1\. History of allergy against study drug related components or drugs
•2\. Administration of chemotherapy or radiotherapy within 3 weeks prior to day of first dose of study drug or during the study;
•3\. Chemotherapy with nitrosoureas or mitomycin C within 6 weeks prior to day 1
•4\. Antineoplastic therapy with biological agents within 2 weeks before day 1 or within 5 drug half\-lifes (t½) prior to first dose, whichever time period is longer
•5\. Participation in an investigational therapeutic study within 3 weeks or within 5 drug half\-lives (t1/2\) prior to first dose, whichever time is longer.
•6\. Treatment with BT062 in previous studies;
•7\. Previous treatment with vinflunine;
•8\. Planned tumor\-reduction surgery and surgical removal of well accessible metastases;
•9\. Anticipation of the need to apply radiotherapy during the first 3 cycles/12 weeks of the study.
•10\. Major surgery within 4 weeks prior to Day 1;