A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

Inhibrx, Inc.0 个研究点目标入组 201 人开始时间: 2021年12月3日最近更新: 2023年7月18日

研究概览

暂无简介。

•1. Males or females aged = 18 years
•2. Conventional chondrosarcoma, unresectable (i.e., resection with curative intent to remove cancer completely is not possible) ) or metastatic.
•3. 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.
•4. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
•5. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
•6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
•7. Estimated life expectancy of at least 12 weeks.
•8. Male and female patients of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate), from the time of signing informed consent and for the duration of study participation through 3 months, following the last dose of study treatment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 151
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Any prior exposure to DR5 agonists.
•2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
•3. Receipt of any investigational or approved anticancer drug(s) including biological product(s) within 4 weeks or within 5 half-lives, whichever is longer, prior to the first dose of study treatment.
•4. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
•5. 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.
•6. Chronic liver diseases. Exception: Patients aged < 64 years with NAFLD detected by imaging are acceptable if adequate hepatic function as defined in the inclusion criteria is confirmed. Note: Patients aged > 65 years with non-alcoholic fatty liver disease (NAFLD) are excluded from the study.
•7. Patients aged > 65 years and with BMI > 30 kg/m2 are excluded from the study.
•8. Other exclusion criteria per protocol.

发起方