Study of INBRX-109 in Conventional Chondrosarcoma

Phase 2

Recruiting

• Conditions: Conventional Chondrosarcoma
• Interventions: Drug: INBRX-109; Drug: Placebo

• Registration Number: NCT04950075
• Lead Sponsor: Inhibrx Biosciences, Inc

Brief Summary

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

Detailed Description

This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

Study Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-06
• Study Start: 2021-09-23
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
2. 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.
3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Estimated life expectancy of at least 12 weeks.
7. Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion Criteria

1. Any prior exposure to DR5 agonists.
2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
4. 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.
5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
7. Other exclusion criteria per protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INBRX-109	INBRX-109	IV every three weeks
Placebo	Placebo	IV every three weeks

Primary Outcome Measures

Name	Time	Method
Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo	3 years	Progression-free survival per RECISTv1.1 will be determined.

Secondary Outcome Measures

Name	Time	Method
Overall survival of patients comparing INBRX-109 and placebo	3 years	Overall Survival in the ITT population
ORR per RECISTv1.1 by real-time IRR.	3 years	Tumor response will be determined by RECISTv1.1.
PFS per RECISTv1.1 by Investigator assessment	3 years	PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo	3 years	Quality of life will be determined.
DCR per RECISTv1.1 by real-time IRR	3 years	measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
Characterize the pharmacokinetics of INBRX-109.	3 years	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 (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit.
Immunogenicity of INBRX-109	3 years	Frequency of anti-drug antibodies against INBRX-109 will be determined.
DOR per RECISTv1.1 by real-time IRR	3 years	evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
To evaluate the safety and tolerability of INBRX-109	3 years	Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Trial Locations

Locations (58)

Precision NextGen Oncology & Research Center; 🇺🇸 Beverly Hills, California, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

University of Oklahoma - Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Centre Oscar Lambret; 🇫🇷 Lille, France

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone; 🇮🇹 Palermo, Italy

Mayo Clinic Cancer Center; 🇺🇸 Phoenix, Arizona, United States

University of California, San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

Sarcoma Oncology Center; 🇺🇸 Santa Monica, California, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

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