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

Inhibrx, Inc.0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: Inhibrx, Inc.
入组人数: 18

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•To be eligible for study entry patients must satisfy all of the following
•1. Males or females aged >= 18 to <= 85 years.
•Note: Potential inclusion of patients who are chronologically older than 85
•years, but with Eastern Cooperative Group Performance Status (ECOG PS) 0 and a
•younger biologic age per comprehensive geriatric assessment, must be based on
•discussion with the Medical Monitor or Study Director.
•2. Conventional (or primary) chondrosarcoma (Note: must be confirmed by local
•institutional or reference pathology review, but this confirmation is not
•required for enrollment)
•Metastatic or unresectable (i.e., not amenable to tumor resection with
•curative intent),
•The availability of archival tissue or a fresh cancer biopsy is mandatory for
•enrollment.
•- Note: A confirmation of IDH mutational status (per Clinical Laboratory
•Improvement Amendments [CLIA]-certified assay or equivalent) is required for
•stratification prior to randomization, any status is allowed, i.e. IDH1, IDH2
•or wildtype.
•Any number of prior lines of systemic therapy are allowed.
•- Note: Since there are no FDA/EMA approved systemic therapies for this
•population, patients with unresectable and/or metastatic disease who have not
•received prior systemic therapy may be eligible, provided that they have
•exhausted all clinically relevant (localized and/or palliative) treatment
•options as per investigator*s preference as per local practice guidelines.
•Furthermore, patients with oligometastatic disease (low disease burden,
•resectable) must have exhausted all clinically relevant options including
•palliative radiation, surgery or chemotherapy with non-curative intent.
•3. Measurable disease by RECISTv1.1.
•Note: Tumor lesions that are 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 radiation.
•4. Evidence of confirmed radiographic disease progression per RECISTv1.1
•criteria within 6 months prior to the start of the study treatment
•Note: Potential inclusion of patients with progression, which was not
•determined or confirmed by RECISTv1.1 (e.g., bone only disease), must be
•discussed and approved by the Medical Monitor or Study Director.
•5. Adequate laboratory parameters:
•Adequate hepatic function:
•* AST, ALT and GGT within ULN, and Bilirubin within ULN for patients without
•liver metastasis.
•* AST, ALT and GGT <= 2.5 x ULN, and Bilirubin <= 1.5 x ULN for patients with
•liver metastasis.
•* Exception: Bilirubin <= 2.5 x ULN for patients who have known serum bilirubin
•increases due to underlying Gilbert*s Syndrome or familial benign unconjugated
•hyperbilirubinemia.
•- Note: As transient elevations in GGT can occur due to nonhepatobiliary
•etiologies, the test can be repeated during Screening after consultation with
•Medical Monitor.
•Adequate renal function: Creatinine clearance >= 50 mL/min.
•Adequate hematologic function: Absolute neutrophil count (ANC) >= 1500
•cells/µL, Platelet count >= 100,000/µL and Hemoglobin >= 8.0 g/dL.
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排除标准

•Patients will be excluded from the study if one or more of the following
•criteria is/are applicable:
•1. Any prior exposure to DR5 agonists.
•2. Receipt 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.
•3. Receipt of radiotherapy (with the exception of palliative localized
•radiation) within 4 weeks to the first dose of study treatment. Patients must
•have recovered from all radiation-related toxicities and not require
•corticosteroids.
•Note: A 1-week washout is required for palliative radiation to non-central
•nervous system (CNS) disease.
•Note: patients who had prior radiotherapy involving the liver (total
•calculated dose to the liver >10Gy) are excluded.
•4. Receipt of liver-directed therapies (e.g., RFA, TACE/embolization,
•cryotherapy, SBRT, or others) within 12 months prior to the first dose of study
•Note: patients who had prior radioembolization with Yttrium-90 beads are
•5. Allergy or sensitivity to INBRX-109 or known allergies to Chinese hamster
•ovary (CHO) cell-produced antibodies, which in the opinion of the investigator
•suggest an increased potential for an adverse hypersensitivity to INBRX-109.
•6. Non-conventional CS, e.g., clear-cell, mesenchymal, extraskeletal myxoid,
•myxoid*, and dedifferentiated CS.
•Note: *Conventional CS with myxoid features are considered Grade 2
•conventional CS and are allowed in this study.
•7. 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 of INBRX-109. These cases must be reviewed and
•discussed with the medical monitor and sponsor for potential inclusion.
•8. Symptomatic active CNS metastases or leptomeningeal disease.
•Exception: Patients with asymptomatic CNS metastases are eligible if
•controlled, defined as >= 4 weeks of stable neurologic function following CNS
•directed therapy (stereotactic radiotherapy, definitive surgical resection,
•and/or whole brain radiotherapy); not requiring steroids; and no evidence of
•CNS disease progression as determined by radiographic imaging within 4 weeks
•prior to the first dose of study treatment.
•Note: Patients with spinal cord metastases are allowed.
•Note: Patients with untreated, uncontrolled, ongoing spinal cord compression
•are excluded.
•9. Chronic liver diseases including but not limited to NAFLD or NASH,
•alcohol-related liver disease, cirrhosis, hemochromatosis, Wilson*s disease,
•alpha-1 antitrypsin deficiency, liver hemangioma, hepatic or biliary autoimmune
•disorders (e.g., primary biliary cholangitis, autoimmune hepatitis) ), history
•of portal or hepatic vein thrombosis, sinusoidal occlusion syndrome.
•Note: Liver imaging is required for all patients to rule out chronic liver
•diseases. When NAFLD, NASH, fibrosis, or cirrhosis are suspected, liver MRI or
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研究者

发起方

Inhibrx, Inc.

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