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Study of INBRX-109 in Conventional Chondrosarcoma

PHASE2RECRUITING

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

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.

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.

Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.

Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.

Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

Estimated life expectancy of at least 12 weeks.

Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion criteria

Any prior exposure to DR5 agonists.

Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.

Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.

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.

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.

Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.

Other exclusion criteria per protocol.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-09-23

Primary completion: 2024-12-01

Study completion finish: 2025-07-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT04950075

Intervention or treatment

DRUG: INBRX-109

DRUG: Placebo

Conditions

• Conventional Chondrosarcoma

Image related to Conventional Chondrosarcoma

Condition: Conventional Chondrosarcoma
DRUG: INBRX-109 and other drugs
Adelaide, Not Specified, Australia and more
Sponsor: Inhibrx Biosciences, Inc

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Chris O'Brien Lifehouse
Camperdown, Not Specified, Australia
Princess Alexandra Hospital
Woolloongabba, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: INBRX-109 IV every three weeks	DRUG: INBRX-109 Tetravalent DR5 Agonist Antibody
PLACEBO_COMPARATOR: Placebo IV every three weeks	DRUG: Placebo Placebo

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo	Progression-free survival per RECISTv1.1 will be determined.	3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Overall survival of patients comparing INBRX-109 and placebo	Overall Survival in the ITT population	3 years
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
PFS per RECISTv1.1 by Investigator assessment	PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.	3 years
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
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
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
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
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 (λz, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough)	3 years
Immunogenicity of INBRX-109	Frequency of anti-drug antibodies against INBRX-109 will be determined.	3 years

Frequently Asked Questions

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References

Clinical Trials Gov: Study of INBRX-109 in Conventional Chondrosarcoma