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Study of INBRX-109 in Conventional Chondrosarcoma

PHASE2ACTIVE_NOT_RECRUITING

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Study details:

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).

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
  2. 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.
  3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
  4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  6. Estimated life expectancy of at least 12 weeks.
  7. Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion criteria

  1. Any prior exposure to DR5 agonists.
  2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
  3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
  4. 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.
  5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
  6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
  7. Other exclusion criteria per protocol.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE2

trial

Study ID

NCT04950075

Intervention or treatment

DRUG: INBRX-109

DRUG: Placebo

Conditions

  • Conventional Chondrosarcoma

  • Condition: Conventional Chondrosarcoma

  • DRUG: INBRX-109 and other drugs

  • Adelaide, Australia and more

  • Sponsor: Inhibrx Biosciences, Inc

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Royal Adelaide Hospital

Select from list below to view details:

  • Royal Adelaide Hospital

    Adelaide, Australia

  • Chris O'Brien Lifehouse

    Camperdown, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Australia

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Who is running the clinical trial?

IBI

Inhibrx Biosciences, Inc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: INBRX-109
  • IV every three weeks
Drug: INBRX-109
    PLACEBO_COMPARATOR: Placebo
    • IV every three weeks
    Drug: Placebo

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placeboProgression-free survival per RECISTv1.1 will be determined.3 years

      Secondary Outcome

      MeasureDescriptionTime Frame
      Overall survival of patients comparing INBRX-109 and placeboOverall Survival in the ITT population3 years
      ORR per RECISTv1.1 by real-time IRR.Tumor response will be determined by RECISTv1.1.3 years
      PFS per RECISTv1.1 by Investigator assessmentPFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.3 years
      Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placeboQuality of life will be determined.3 years
      DCR per RECISTv1.1 by real-time IRRmeasured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo3 years
      DOR per RECISTv1.1 by real-time IRRevaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo3 years
      To evaluate the safety and tolerability of INBRX-109Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.3 years
      Characterize the pharmacokinetics of INBRX-109.AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit.3 years
      Immunogenicity of INBRX-109Frequency of anti-drug antibodies against INBRX-109 will be determined.3 years
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: Study of INBRX-109 in Conventional Chondrosarcoma

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