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Study to Investigate the Safety, Blood Levels and Activity of MP0310 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04049903
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Molecular Partners AG

Brief Summary:
To evaluate the safety and tolerability of MP0310, a DARPin® therapeutic candidate for tumor targeted activation of T cells, in patients with advanced solid tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: MP0310 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-In-Human, Single-Arm, Multi-Center, Open-Label, Repeated-Dose, Dose-Escalation Study of MP0310 in Patients With Advanced Solid Tumors
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
Experimental: MP0310
Enrollment will follow a standard 3 + 3 dose escalation design. Sequential Cohorts of patients will be dosed until the MTD is exceeded, unacceptable toxicity is reached, or until the maximum protocol specified dose is delivered. Up to 12 additional patients in total may be included at selected dose levels (up to 3).
Drug: MP0310
MP0310 will be examined for safety, tolerability, PK, and PD activity in subjects with advanced solid tumors




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: From signing of informed consent form (ICF) until 10 weeks following the last dose or start of new anticancer therapy. ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  2. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: First 21 days of dosing. ]
    Dose-limiting toxicities will be reviewed as a subset of AEs that occur within the first 21 days of dosing and meet the protocol-specified criteria.

  3. Maximum tolerated dose (MTD) or a tolerated dose below MTD (if MTD is not reached) [ Time Frame: From signing of ICF until 10 weeks following the last dose or start of new anticancer therapy. ]
    Based on occurrence of DLTs within a 3+3 clinical trial design

  4. Recommended expansion dose (RED) [ Time Frame: From signing of ICF until 10 weeks following the last dose or start of new anticancer therapy. ]
    Based on incidence and nature of DLTs, and incidence, nature, and severity of AEs and serious adverse events (SAEs)


Secondary Outcome Measures :
  1. Serum concentration - time profiles [ Time Frame: 24 months ]
    Including parameters like maximal serum concentration (Cmax), time at Cmax (Tmax), minimal serum concentration (Cmin)

  2. Area under the serum concentration-time curve (AUC) [ Time Frame: 24 months ]
    Pharmacokinetic (PK) analysis of MP0310

  3. Total clearance (CL) [ Time Frame: 24 months ]
    PK analysis of MP0310

  4. Volume of distribution (Vd), volume at steady state (Vss) [ Time Frame: 24 months ]
    PK analysis of MP0310

  5. Terminal elimination half-life (t1/2) [ Time Frame: 24 months ]
    PK analysis of MP0310

  6. Accumulation ratio [ Time Frame: 24 months ]
    PK analysis of MP0310

  7. Incidence of anti-drug-antibodies [ Time Frame: 24 months ]
    Serum concentration-time profile of anti-drug antibodies

  8. Objective response rate (ORR) [ Time Frame: 24 months ]
    The proportion of participants with confirmed complete response (CR) and partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)

  9. Disease control rate (DCR) [ Time Frame: 24 months ]
    Stable disease lasting 4 or more weeks following the initiation of MP0310

  10. Duration of response (DoR) [ Time Frame: 24 months ]
    For participants with CR or PR, DOR will be calculated as time from initial response of CR or PR to progressive disease or death.



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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

  • Advanced solid tumor of one of the following types, treated with at least one line of systemic therapy, with no available treatment options: Colorectal, Ovarian, Endometrial, Gastric, Pancreatic, Anal, Cervical, Squamous cell cancer of the head and neck, Mesothelioma, Prostate, Non-small cell lung cancer, Melanoma, Urothelial/bladder, Microsatellite instability high tumors of any type, Cutaneous squamous cell
  • ≥18 years of age
  • Eastern Cooperative Oncology Group performance status (ECOG; PS) ≤1
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
  • Mandatory paired (pre- and on-treatment) biopsies
  • Adequate organ function as defined in the protocol
  • A woman of childbearing potential (WOCBP) should only be included after a confirmed menstrual period and a negative serum pregnancy test at Screening.
  • Female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

    • Not a woman of child bearing potential (WOCBP) as defined in the protocol
    • A WOCBP who agrees to follow the contraceptive guidance as defined in the protocol
  • Men who are not surgically sterilized and who are partners of WOCBP must be willing to use adequate contraception as detailed in the protocol

Exclusion Criteria

  • Autoimmune diseases, except auto-immune endocrinopathies that are stable with hormone replacement therapy
  • Inflammatory diseases such as arthritis, colitis, liver fibrosis, cirrhosis, interstitial fibrosis, or chronic obstructive pulmonary disease (COPD)
  • Bisphosphonate therapy for symptomatic hypercalcemia
  • Use of an investigational agent within the past 4 weeks before first MP0310 administration in this study
  • Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to first MP0310 administration; however, the following are allowed:

    • Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer
    • Hormone-replacement therapy or oral contraceptives
    • Palliative radiotherapy for bone metastases 2 weeks prior to first MP0310 administration
  • Corticosteroid use exceeding 10 mg/day prednisone or equivalent
  • Left ventricular ejection fraction of <50%
  • Any history or evidence of clinically significant cardiovascular disease as defined in the protocol
  • Severe dyspnea, pulmonary dysfunction, or need for continuous supportive oxygen inhalation
  • Arterial thromboembolic event, stroke, or transient ischemia attack within the past 12 months
  • Known central nervous system (CNS) metastasis that are either untreated or are treated but are associated with clinical symptoms (e.g., headache, convulsions). Participants with CNS metastasis that have been treated with radiotherapy and/or surgery are eligible if they are clinically without symptoms for at least 6 weeks; if under treatment with corticosteroids (not exceeding 10 mg/day prednisone or equivalent) and/or anticonvulsive agents patients must be on a stable dose for at least two weeks.
  • Any active uncontrolled bleeding, or a bleeding diathesis
  • Patients with a known positivity for human immunodeficiency virus (HIV)
  • Patients with active hepatitis B (chronic or acute; HBV)
  • Patients with active hepatitis C (HCV) infection
  • Serious or non-healing wound, skin ulcer, or non-healing bone fracture
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • Albumin <2.8 g/dL or <28 g/L, and without albumin transfusion for ≥7 days prior to screening
  • Any live virus vaccine within 30 days prior to the start of therapy (Note: Inactivated seasonal flu vaccine is acceptable)
  • Has had an allogenic tissue/solid organ transplant
  • History of another primary malignancy except for:

    • Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product and of relatively low potential risk for recurrence
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    • Adequately treated carcinoma in situ without evidence of disease
    • Incidental histologic findings of prostate cancer that, in the opinion of the Investigator, is not deemed to require active therapy
  • Male or female participants of reproductive potential who are not willing to employ adequate contraception from screening to 3 months after the last MP0310 administration

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): NCT04049903


Contacts
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Contact: Medical Director, MPAG +41 44 755 7700 info@molecularpartners.com

Locations
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France
Centre Léon Bérard Recruiting
Lyon, France, 69008
Institut Claudius Regaud; Institut Universitaire du Cancer Toulouse Oncopole (IUCT-O) Recruiting
Toulouse, France, 31059
Insitut Gustave Roussy Recruiting
Villejuif, France, 94805
Sponsors and Collaborators
Molecular Partners AG

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Responsible Party: Molecular Partners AG
ClinicalTrials.gov Identifier: NCT04049903     History of Changes
Other Study ID Numbers: MP0310-CP101
2018-004786-13 ( EudraCT Number )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms