A Phase 2 study of INBRX-109 in adults with an unresectable or metastasized cancer of the bones and joints (Chondrosarcoma).

Phase 1

• Conditions: nresectable or metastatic conventional chondrosarcoma; MedDRA version: 21.1Level: PTClassification code 10008734Term: ChondrosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-002635-35-IE
• Lead Sponsor: Inhibrx, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-10
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

1. Males or females aged = 18 years to = 85 years
2. Conventional chondrosarcoma, unresectable (i.e., not amenable to tumor resection with curative intent) 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. Evidence of confirmed radiographic disease progression 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. 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.
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

Exclusion Criteria

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 anti-cancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment, whichever is longer for biologics, and 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.
4.Receipt of radiotherapy (with the exception of palliative localized radiation) within 4 weeks 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.
5. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
6. 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.
7. Chronic liver diseases including but not limited to non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (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: Patients with any imaging evidence of NAFLD, NASH, fibrosis, or cirrhosis, regardless of prior history and LFTs at baseline are excluded from the study (liver MRI or MRE are preferred, other imaging modalities, such as CT [with contrast], ultrasound, transient elastography, are acceptable).
Exception: Patients aged < 45 years with NAFLD detected by imaging may participate in the study 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.
Note: Patients aged > 65 =45 years with NAFLD are excluded from the study.
8. Patients aged = 65 years and with BMI = 30 kg/m2 and/or patients aged =45 years with HSI =36 or FLI =60 are excluded from the study.
9. Any evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
10. Other exclusion criteria per protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified