Unresectable or metastatic conventional chondrosarcoma MedDRA version: 21.1 Level: PT Classification code 10008734 Term: Chondrosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: INBRX-109
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: Not available
Current Sponsor code: INBRX-109
Other descriptive name: Recombinant humanized IgG
Sponsors
Inhibrx, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anticancer efficacy of INBRX-109 in the Intention To Treat (ITT) population as measured by Progression Free Survival (PFS) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo. ;Secondary Objective: • Evaluate the anticancer efficacy of INBRX-109 as measured by overall survival (OS) comparing INBRX-109 and placebo. • Evaluate the anticancer efficacy of INBRX-109 as measured by PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo. • Evaluate the quality of life (QoL) as measured by EORTC QLQ-C30, EQ-5D-5L, PGI-C and PGI-S comparing INBRX-109 and placebo. • Evaluate the anticancer efficacy of INBRX-109 as measured by objective response rate (ORR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo. • Evaluate the anticancer efficacy of INBRX-109 as measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo. • Evaluate the safety and tolerability of INBRX-109 • Characterize the pharmacokinetics (PK) of INBRX-109 • Evaluate the frequency of ADA, and neutralizing ADA (NAb), against INBRX-109 and to explore the potential relationship with safety, PK and efficacy of INBRX-109 ;Primary end point(s): • Progression Free Survival (PFS) per RECISTv1.1 assessed by central IRR in the ITT population ;Timepoint(s) of evaluation of this end point: From study start until the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall Survival (OS) • Progression Free Survival (PFS) per RECISTv1.1 by Investigator assessment • Quality of Life (QoL) per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S • Objective Response Rate (ORR) and Duration of Response (DOR) per RECISTv1.1 by real-time Independent Radiology Review (IRR) • Disease Control Rate (DCR) per RECISTv1.1 by real-time IRR • Treatment-Emergent Adverse Event (TEAEs) including SAEs • PK characterization: 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 (?z, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit • Frequency of Anti-Drug Antibodies (ADA) and neutralizing ADA (NAb) ;Timepoint(s) of evaluation of this end point: • OS: from study start until the end of the study (EoS) • PFS: until DP • QoL: from study start until EoS • ORR and DOR per RECISTv1.1 by IRR: until Disease Progression (DP) • DCR: until DP • TEAEs including SAEs: from study start until EoS. • PK characterization: from study start until EoS • ADA and NAb: from study start until EoS | — |
Countries
France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical Program Manager
Inhibrx, Inc.
Outcome results
None listed