Study of INBRX-109 in Conventional Chondrosarcoma

Conventional Chondrosarcoma Clinical Trial

— ChonDRAgon  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950075
• Other study ID #: Ph2 INBRX-109 SA CS
• Status: Recruiting
• Phase: Phase 2
• Start date: September 23, 2021
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Inhibrx, Inc.
• Contact: Study Director, -Inhibrx
• Phone: 858-500-7833
• Email: clinicaltrials[@]inhibrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 201
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chondrosarcoma
• Conventional Chondrosarcoma

Intervention

Drug:
• INBRX-109
Tetravalent DR5 Agonist Antibody
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Chris O'Brien Lifehouse	Camperdown
Australia	Princess Alexandra Hospital	Woolloongabba
France	Institut Bergonie	Bordeaux	Cedex
France	Centre Leon Berard	Lyon
France	AP-HM - Hôpital de la Timone	Marseille
France	Gustave Roussy	Villejuif
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Universitätsmedizin Mannheim	Mannheim
Ireland	Saint Vincent's University Hospital part of Irish Sarcoma Group	Dublin
Italy	IRCCS Istituto Ortopedico Rizzoli di Bologna	Bologna
Italy	La Fondazione e l'Istituto di Candiolo	Candiolo
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Nuovo Ospedale di Prato	Prato
Italy	Policlinico Universitario Campus Biomedico	Roma
Netherlands	Groningen UMC	Groningen
Netherlands	Leiden University Medical Center	Leiden
Spain	Hospital de la Santa Creu i Sant Pau Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitari i Politecnic La Fe	Valencia
United Kingdom	Royal Marsden NHS Foundation Trust	London
United Kingdom	University College London Hospital (UCL)	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Churchill Hospital	Oxford
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University - Robert H. Lurie Comprehensive Cancer Center	Chicago	Illinois
United States	Rush Cancer Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Oklahoma State University (OSU) - Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University (OHSU) Knight Cancer Institute	Portland	Oregon
United States	Washington University School of Medicine - St. Louis	Saint Louis	Missouri
United States	University of California, San Francisco (UCSF)	San Francisco	California
United States	Sarcoma Oncology Center	Santa Monica	California
United States	Washington University - Seattle	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Inhibrx, Inc.

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate Quality of Life	QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S	3 years
Other	Potential predictive response biomarkers	Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109	3 years
Other	PFS per RECISTv1.1 by Investigator assessment	evaluate the anticancer efficacy of INBRX-109 as measured by PFS (by Investigator assessment) for crossover population after treatment with INBRX-109	3 years
Other	ORR per RECISTv1.1 by Investigator assessment	evaluate the anticancer efficacy of INBRX-109 as measured by ORR (by Investigator assessment) for crossover population after treatment with INBRX-109	3 years
Primary	Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo	Progression-free survival per RECISTv1.1 will be determined.	3 years
Secondary	Overall survival of patients comparing INBRX-109 and placebo	Overall Survival in the ITT population	3 years
Secondary	Overall response rate (in percent), duration of response (in time) and disease control rate (in percent)	Tumor response will be determined by RECISTv1.1.	3 years
Secondary	PFS per RECISTv1.1 by Investigator assessment	PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.	3 years
Secondary	Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo	Quality of life will be determined.	3 years
Secondary	DCR per RECISTv1.1 by real-time IRR	measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo	3 years
Secondary	DOR per RECISTv1.1 by real-time IRR	evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo	3 years
Secondary	To evaluate the safety and tolerability of INBRX-109	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.	3 years
Secondary	Characterize the pharmacokinetics of INBRX-109.	AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non- Sponsor: Inhibrx, Inc. Version 5.0 (Amendment 4) Protocol Number: Ph2 INBRX-109 SA CS 28-Feb-2023 Page 41 of 113 CONFIDENTIAL Objective Endpoint compartmental method as the data allow. Other PK parameters (?z, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough)	3 years
Secondary	Immunogenicity of INBRX-109	Frequency of anti-drug antibodies against INBRX-109 will be determined.	3 years