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NeoplasmsPhase 1/2NCT02194426

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

A Phase 1/2 study testing MP0250 in people with Neoplasms, run by Molecular Partners AG at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is looking at a new DARPin® drug candidate, 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
MP0250
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
4 sitesin 3 countries
Study dates
Jul 2014to 20 Feb 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥ 18 years
  • 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
  • Progressive or stable disease documented radiologically in the 4 weeks prior to screening
  • Presence of a measurable tumour or a tumour evaluable per RECIST v1.1
  • ECOG performance status ≤ 1
  • Life expectancy ≥ 12 weeks
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  • 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
  • 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)
  • 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
  • Female patients with a negative pregnancy test result at screening and baseline

Who cannot join

  • Female patients pregnant or breast-feeding
  • Haematological malignancies or other secondary malignancy, that is currently clinically significant or requires active intervention
  • Known untreated or symptomatic brain metastases
  • Predominantly squamous non-small cell lung carcinoma
  • 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:
  • Nitrosoureas: 6 weeks ii. Monoclonal antibodies: 8 weeks
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  • 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
  • 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
  • Exclusion criterion removed
  • 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
  • Serious non-healing wound, active ulcer or untreated bone fracture
  • Proteinuria at screening as defined by ≥ 1+ on urinalysis dipstick, confirmed by ≥ 1g in 24h urinalysis
  • Uncontrolled hypertension or any other serious cardiovascular or cardiac condition as judged by the investigator
  • Severe or uncontrolled renal insufficiency

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

United Kingdom2 sites

  • Study Site Cambridge

    Cambridge, Cambridgeshire

  • Study Site Oxford

    Oxford, Oxfordshire

Other trials in United Kingdom

Spain1 site

  • Study Site Barcelona

    Barcelona, Catalonia

Other trials in Spain

Switzerland1 site

  • Study Site St. Gallen

    Sankt Gallen, Canton of St. Gallen

Other trials in Switzerland

About this study

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

This research study is looking at a new DARPin® drug candidate, 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.

Conditions
Neoplasms
Being tested
MP0250
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MP0250Drug

    Intravenous application by infusion of MP0250 at up to six dose levels, every other week for up to 24 infusions.

Study groups in NCT02194426
Study groupRoleWhat they receive
MP0250Experimentalsee section "intervention description" below
Receives: Drug: MP0250

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with dose limiting toxicities

    Measured: From the Day 0 (first infusion) up to 35 days

  2. Vital signs

    Measured: From inclusion (week -4) up to week 56

  3. Frequency of adverse events

    Measured: From inclusion up to week 56

  4. MP0250 plasma concentration-time profile

    Measured: From Day 0 (first infusion) up to week 56

  5. Nature of dose limiting toxicities

    Measured: From the Day 0 (first infusion) up to 35 days

  6. Nature of adverse events

    Measured: From inclusion up to week 56

  7. Severity of adverse events

    Measured: From inclusion up to week 56

  8. Blood chemistry values

    Measured: From inclusion (week -4) up to week 56

  9. Haematology values

    Measured: From inclusion (week -4) up to week 56

  10. Urine values

    Measured: From inclusion (week -4) up to week 56

  11. Electrocardiogram measurements

    Measured: From inclusion (week -4) up to week 56

  12. Pharmacokinetics parameters

    Measured: From Day 0 (first infusion) up to week 56

Secondary outcomes (2)

  1. Incidence of anti-drug-antibodies

    Measured: From the Day 0 (first infusion) up to week 56

  2. Titre of anti-drug-antibodies

    Measured: From the Day 0 (first infusion) up to week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completion20 Feb 2018
  4. Study completion20 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194426
Sponsor's protocol ID
MP0250-CP101
Other IDs
2014-000366-21, 2014
Status last verified
Apr 2018
First submitted
12 Jun 2014
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No

Publications

  • Baird RD, Linossi C, Middleton M, Lord S, Harris A, Rodon J, Zitt C, Fiedler U, Dawson KM, Leupin N, Stumpp MT, Harstrick A, Azaro A, Fischer S, Omlin A. First-in-Human Phase I Study of MP0250, a First-in-Class DARPin Drug Candidate Targeting VEGF and HGF, in Patients With Advanced Solid Tumors. J Clin Oncol. 2021 Jan 10;39(2):145-154. doi: 10.1200/JCO.20.00596. Epub 2020 Dec 10.

    PubMed 33301375

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MP0250 in people with Neoplasms, run by Molecular Partners AG at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with dose limiting toxicities (time frame: From the Day 0 (first infusion) up to 35 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02194426, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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