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First-in-human Study to Investigate the Safety, Tolerability and Blood Levels of the Test Drug MP0250 in Cancer Patients

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ClinicalTrials.gov Identifier: NCT02194426
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Molecular Partners AG

Brief Summary:
This research study is looking at a new DARPin based medication, called MP0250. There is evidence from preclinical studies that MP0250 may be effective in the treatment of cancer. This is the first study of MP0250 in humans and its main purpose is to test its safety and tolerability in patients with cancer. This study will also examine how the drug is changed by and removed from the body and look for indicators that the drug may be effective against cancer. This study will test several different dose levels of the study drug to determine the safety and tolerability profile of the drug.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: MP0250 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Multi-centre, Open-label, Repeated-dose, Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MP0250 in Patients With Advanced Solid Tumours
Study Start Date : July 2014
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Arm Intervention/treatment
Experimental: MP0250
see section "intervention description" below
Drug: MP0250
Intravenous application by infusion of MP0250 at up to six dose levels, every other week for up to 24 infusions.




Primary Outcome Measures :
  1. Proportion of patients with dose limiting toxicities [ Time Frame: From the Day 0 (first infusion) up to 35 days ]
  2. Vital signs [ Time Frame: From inclusion (week -4) up to week 56 ]
  3. Frequency of adverse events [ Time Frame: From inclusion up to week 56 ]
  4. MP0250 plasma concentration-time profile [ Time Frame: From Day 0 (first infusion) up to week 56 ]
  5. Nature of dose limiting toxicities [ Time Frame: From the Day 0 (first infusion) up to 35 days ]
  6. Nature of adverse events [ Time Frame: From inclusion up to week 56 ]
  7. Severity of adverse events [ Time Frame: From inclusion up to week 56 ]
  8. Blood chemistry values [ Time Frame: From inclusion (week -4) up to week 56 ]
  9. Haematology values [ Time Frame: From inclusion (week -4) up to week 56 ]
  10. Urine values [ Time Frame: From inclusion (week -4) up to week 56 ]
  11. Electrocardiogram measurements [ Time Frame: From inclusion (week -4) up to week 56 ]
  12. Pharmacokinetics parameters [ Time Frame: From Day 0 (first infusion) up to week 56 ]

Secondary Outcome Measures :
  1. Incidence of anti-drug-antibodies [ Time Frame: From the Day 0 (first infusion) up to week 56 ]
  2. Titre of anti-drug-antibodies [ Time Frame: From the Day 0 (first infusion) up to week 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 18 years
  2. Histologically confirmed and documented advanced or metastatic solid tumour refractory to at least 1 prior regimen of standard treatment or for which no curative therapy is available and for whom MP0250 is a reasonable option
  3. Progressive or stable disease documented radiologically in the 4 weeks prior to screening
  4. Presence of a measurable tumour or a tumour evaluable per RECIST v1.1
  5. ECOG performance status ≤ 1
  6. Life expectancy ≥ 12 weeks
  7. Adequate haematological function prior to first dose, defined as:

    • Absolute neutrophils count ≥ 1500 cells/μL
    • Haemoglobin ≥ 9 g/dL
    • Platelet count > 100,000/μL
    • Prothrombin time or partial thromboplastin time < 1.2 x ULN
  8. Adequate renal function prior to first dose, defined as either

    • Serum creatinine < 1.5 mg/dL or
    • Serum creatinine clearance ≥ 50 mL/min/m2 (by Cockroft-Gault equation)
  9. Adequate hepatic function prior to first dose, defined as

    • Total bilirubin ≤ 1.5 x ULN
    • AST/ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if known hepatic metastases
    • Alkaline phosphatase ≤ 2.5 x ULN, or ≤ 5 x ULN if known hepatic or bone metastases
  10. Female patients with a negative pregnancy test result at screening and baseline

Exclusion Criteria:

  1. Female patients pregnant or breast-feeding
  2. Haematological malignancies or other secondary malignancy, that is currently clinically significant or requires active intervention
  3. Known untreated or symptomatic brain metastases
  4. Predominantly squamous non-small cell lung carcinoma
  5. Anti-tumour treatment within 4 weeks of the first infusion of MP0250, such as chemotherapy, experimental or targeted therapy, biologics, hormonal therapy and radiotherapy. The anti-tumour treatments below need longer wash-out periods and must not be given within the indicated weeks of the first infusion of MP0250:

    i. Nitrosoureas: 6 weeks ii. Monoclonal antibodies: 8 weeks

  6. Exceptions: the following anti-tumour treatments are allowed as indicated i. Palliative radiation to bone metastases to relieve bone pain ii. Standard of care treatment such as bone modifying agents (i.e. bisphosphonates), denosumab, maintenance hormonal therapy for metastatic prostate and breast cancers, hormone-replacement therapy, and oral contraceptives
  7. Presence of residual toxicities of CTC-AE Grade ≥ 2 after prior anti-tumour therapy at screening. Except meeting other exclusion criteria, grade 1 toxicities related to previous treatments are acceptable at the time of the first infusion of MP0250, as well as Grade 2 alopecia
  8. Exclusion criterion removed
  9. Major surgical procedures, open biopsy or significant traumatic injury within 4 weeks of first dose or anticipation of major surgical procedure during the course of the study, core biopsy or minor surgical procedures within 1 week of first dose
  10. Serious non-healing wound, active ulcer or untreated bone fracture
  11. Proteinuria at screening as defined by ≥ 1+ on urinalysis dipstick, confirmed by ≥ 1g in 24h urinalysis
  12. Uncontrolled hypertension or any other serious cardiovascular or cardiac condition as judged by the investigator
  13. Severe or uncontrolled renal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194426


Locations
Spain
Study Site Barcelona
Barcelona, Catalunya, Spain
Switzerland
Study Site St. Gallen
St. Gallen, Saint Gallen, Switzerland
United Kingdom
Study Site Cambridge
Cambridge, Cambridgeshire, United Kingdom
Study Site Oxford
Oxford, Oxfordshire, United Kingdom
Sponsors and Collaborators
Molecular Partners AG

Responsible Party: Molecular Partners AG
ClinicalTrials.gov Identifier: NCT02194426     History of Changes
Other Study ID Numbers: MP0250-CP101
2014-000366-21 ( EudraCT Number )
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018