Drug Safety Clinical Trial
Official title:
Open-label, Single-centre, Phase I, Multi-dose Escalating Study to Investigate the Safety and Preliminary Efficacy of an i.v. Infusion of the Anti-GRP78 Monoclonal IgM Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple Myeloma
Verified date | October 2015 |
Source | Patrys Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich-Institut |
Study type | Interventional |
Primary
- To evaluate the safety and tolerability of escalating doses of an intravenous (i.v.)
infusion of PAT-SM6 in subjects with relapsed or refractory multiple myeloma.
Secondary
- To evaluate the efficacy and pharmacodynamics by analysis of serum and urine M protein,
serum free light chains (FLC) κFLC and λFLC, total immunoglobulins, β2-microglobulin,
C-reactive protein (CRP), exploratory biomarkers and anti-PAT-SM6 antibodies.
- To evaluate the duration of response and the progression free survival.
Status | Completed |
Enrollment | 12 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female subjects = 18 years of age - Relapsed or refractory multiple myeloma defined as: Failure of at least 2 previous therapies including an immunomodulatory agent (thalidomide or lenalidomide) and a proteasome inhibitor (unless the subjects were not eligible or refused to receive those treatments), and with progressive disease, defined by an increase of serological or urine myeloma parameters by 25% to the last value - Presence of serum M-protein = 1 g per 100 mL (= 10 g/L) and/or urine M-protein = 200 mg per 24-hour period and/or serum FLCs = 10 mg per 100 mL (= 100 mg/L) combined with an abnormal ratio of lambda and kappa chains - Life expectancy of > 6 months - Karnofsky performance status = 60%, Eastern Cooperative Oncology Group (ECOG) performance status = 2. - Absolute neutrophil count (ANC) = 1.0 (1,000/mm3) and platelets = 30 × 109/L without previous transfusion within the last 2 weeks before first study drug administration - Creatinine clearance = 30 mL/min (calculated using the Cockcroft-Gault equation) - Total bilirubin = 2 × upper normal limit (UNL) - Alanine transaminase (ALT) and aspartate aminotransferase (AST) = 2.5 × UNL - Haemoglobin = 8 g/dL - If a female of childbearing potential, confirmation of a negative pregnancy test before enrolment and use of double-barrier contraception, oral contraceptive plus barrier contraceptive, or confirmation of having undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation - If a male, use of an effective barrier method of contraception during the study and for 3 months after the last dose if sexually active with a female of childbearing potential - Ability to comply with all study-related procedures, medication use, and evaluations - Ability to understand and give written informed consent, and comply with the protocol Exclusion Criteria: - Primary refractory multiple myeloma - Previous treatment with cytotoxic chemotherapy or large-field radiotherapy or other myeloma-specific therapy within 28 days prior to the screening visit (radiation to a single site as concurrent therapy is allowed) - Treatment with a systemic investigational agent within 28 days prior to the screening visit - Hypercalcemia (> 2.7 mmol/L) - Extramedullary plasmocytoma not originating from bone or plasma cell leukaemia - Previous allogenic stem cell transplantation - Known or suspected hypersensitivity to the excipients contained in the study drug formulation - Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association (NYHA) classes III-IV) - Prior therapy with other monoclonal antibodies - Clinical or laboratory evidence of active hepatitis B (positive HBsAg with negative HBsAb) or hepatitis C (positive hepatitis c virus antibody and detectable hepatitis C virus RNA with ALT above the normal range) - Positive HIV test result (ELISA or Western blot) - History of ischemic colitis, stroke or myocardial infarction within the last 6 months - Presence of diarrhoea of grade 2 or higher - Any active uncontrolled systemic infection - Any antibiotic therapy due to infections 2 weeks prior to first study drug administration - Regular dose of corticosteroids during the 2 weeks prior to study entry or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent, or any other immunosuppressive therapy within 2 weeks prior to study entry. - Major surgery = 4 weeks prior to first study drug administration or ongoing side effects of such surgery - Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment - Multiple myeloma with central nervous system involvement. - Second active malignant disease, currently requiring treatment (with the exception of basal cell carcinoma of the skin or curative surgery treated tumours). - Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control - others |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II | Wuerzburg |
Lead Sponsor | Collaborator |
---|---|
Patrys Ltd. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pharmacodynamics | 40 days | No | |
Other | Efficacy | 40 days | No | |
Primary | Overall frequency of adverse events (AEs) (clinical symptoms, laboratory abnormalities, serious adverse events (SAEs) and treatment limiting adverse events) | 14 days | Yes | |
Secondary | Serum concentrations of PAT-SM6 | 11 days | No |
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