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  • Cancer Type: Sarcoma
  • Study Type: Treatment
  • NCT#: NCT04950075
  • Phase: Phase II
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  • Overview

    Study Title:

    A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of INBRX-109 as Any-line Therapy in Conventional Chondrosarcoma

    Summary:

    This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

    Objective:

    1. To evaluate the anticancer efficacy of INBRX-109 in the intention-to-treat (ITT) population as measured by progression free survival (PFS) per RECISTv1.1, assessed by central independent radiology review (IRR), comparing INBRX-109 and placebo; 2. To evaluate the anticancer efficacy of INBRX-109 as measured by overall survival (OS) comparing INBRX-109 and placebo; 3. To evaluate the anticancer efficacy of INBRX-109 as measured by objective response rate (ORR) per RECISTv1.1, assessed by central IRR, comparing INBRX-109 and placebo; 4. To evaluate duration of response (DOR) per RECISTv1.1, assessed by central IRR, comparing INBRX-109 and placebo; 5. To evaluate the anticancer efficacy of INBRX-109 as measured by disease control rate (DCR) per RECISTv1.1, assessed by central IRR, comparing INBRX-109 and placebo. 6. To evaluate the anticancer efficacy of INBRX-109 as measured by PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo; 7. To evaluate quality of life (QoL), comparing INBRX-109 and placebo (i.e., EORTC QLQ-C30); 8. To evaluate the safety and tolerability of INBRX-109; 9. To characterize the pharmacokinetics of INBRX-109; 10. To evaluate the frequency of anti-drug antibodies (ADA), and neutralizing ADA (NAb), against INBRX-109 and to explore the potential relationship with safety, pharmacokinetics and efficacy of INBRX-109.

  • Treatments

    Therapies:

    Immunotherapy; Therapy (NOS)

    Medications:

    INBRX-109 (); Placebo ()

  • Inclusion Criteria

      Inclusion Criteria:
    • Males or females between 18 and 85 years of age. Note: potential inclusion of patients who are chronologically older than 85 years, but with ECOG 0 and a younger biologic age per comprehensive geriatric assessment, must be based on discussion with the Medical Monitor or Study Director
    • Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
    • Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
    • Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
    • Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
    • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.Exception: non-frail, physically active patients with compromised mobility due to prior cancer surgery (e.g. limb amputation, hemipelvectomy etc) should be discussed with the Medical Monitor or Study Director.
    • Estimated life expectancy, in the documented judgment of the Investigator, of at least 12 weeks.
    • Availability of archival tissue or fresh cancer biopsy are mandatory. Note: A confirmation of IDH mutational status (per CLIA-certified assay or equivalent) is required for stratification prior to randomization, any status is allowed, i.e. IDH1, IDH2 or wildtype.
    • Fertile male patients with female partners of childbearing potential and female patients of childbearing potential must agree to avoid impregnating a partner or becoming pregnant, respectively. They must be willing to use acceptable methods of contraception at least 28 days before the first dose of study treatment until 90 days after the last dose of study treatment. A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
    • Other criteria apply
  • Exclusion Criteria

      Exclusion Criteria:
    • Any prior exposure to DR5 agonists. z,,8..t eceipt of any anti-cancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment whichever is shorter. Note: patients who received pazopanib as an immediate prior line, must have a 4 week washout and no evidence of prior or residual hepatotoxicity. Note: patients with any history or evidence of Grade ≥3 hepatotoxicity on prior anti-cancer therapy are excluded
    • Receipt of radiotherapy (with the exception of palliative localized radiation) within 4 weeks prior to the first dose of study treatment. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. Note: 1-week washout is required for palliative radiation to non-CNS disease. Note: patients who had prior radiotherapy involving the liver (total calculated dose to the liver >10Gy) are excluded
    • Receipt of liver-directed therapies (e.g., Radio frequency ablation (RFA), trans-arterial chemoembolization (TACE), radioembolization, cryotherapy, Stereotactic Body Radiation Therapy (SBRT), or others) within 12 months prior to the first dose of study treatment. Note: patients who had prior radioembolization with Yttrium-90 beads are excluded
    • Allergy or sensitivity to INBRX-109 or known allergies to Chinese Hamster ovary (CHO) cell-produced antibodies.
    • Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
    • Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
    • Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion criteria is confirmed.
    • Other exclusions apply

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