A Phase 2 study of INBRX-109 in adults with a type of unresectable or metastasized cancer of the bones and joints (Conventional 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-IT
• Lead Sponsor: Inhibrx, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-05
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

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

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 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.

Study & Design

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