What is the mechanism of action of this treatment?

Chondrosarcoma treatments often include surgery, radiation, and chemotherapy, though the latter is less effective due to the tumor's resistance. Targeted therapies, like INBRX-109, a DR5 agonist, work by inducing apoptosis in cancer cells. This is crucial for chondrosarcoma patients because traditional treatments are limited, and targeted therapies offer a more precise approach to eliminate cancer cells, potentially improving outcomes and reducing side effects.

What side effects are associated with this type of intervention?

Common treatments for chondrosarcoma, including chemotherapy agents like doxorubicin and ifosfamide, and targeted therapies such as pazopanib and sunitinib, often result in side effects like myelosuppression, gastrointestinal disturbances, cardiovascular effects, and fatigue. For treatments similar to INBRX-109 (a DR5 agonist that induces apoptosis), potential side effects may include liver toxicity, gastrointestinal symptoms, and infusion-related reactions.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for treatments similar to INBRX-109 (a DR5 agonist) for chondrosarcoma in the provided context. Generally, chondrosarcoma treatments have included surgical resection, and in some cases, chemotherapy and radiation therapy, although these are less effective for this type of cancer. The study of INBRX-109 represents an ongoing effort to explore new therapeutic options for unresectable or metastatic conventional chondrosarcoma.

What other types of research exist?

Promising novel alternatives to INBRX-109 for chondrosarcoma patients include mTOR inhibitors such as everolimus and temsirolimus, which have shown efficacy in treating various sarcomas. Additionally, tyrosine kinase inhibitors like sunitinib and sorafenib have demonstrated activity in soft tissue sarcomas and may be considered for chondrosarcoma treatment.

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Monoclonal Antibodies

INBRX-109 for Chondrosarcoma (ChonDRAgon Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Inhibrx, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Summary

This trial tests INBRX-109, a specially designed protein, in patients with a hard-to-treat type of bone cancer. The treatment helps the immune system target and kill cancer cells by attaching to a specific marker on these cells.

Who is the study for?

This trial is for people with a type of bone cancer called conventional chondrosarcoma that can't be removed by surgery or has spread. Participants must have shown disease progression recently, be in fairly good health (ECOG PS 0 or 1), and have a life expectancy of at least 12 weeks. They cannot join if they've had certain immune disorders like MS, allergies to the study drug or similar drugs made from Chinese hamster ovary cells, or previous treatment with DR5 agonists.

What is being tested?

The study is testing INBRX-109 against a placebo in patients with advanced chondrosarcoma. It's a Phase 2 trial where participants are randomly assigned to receive either the real drug or a fake one without knowing which one they're getting. The goal is to see if INBRX-109 helps control the cancer better than no active treatment.

What are the potential side effects?

Possible side effects of INBRX-109 may include reactions related to the immune system since it's an antibody-based therapy. Specific side effects aren't listed but could resemble those typical of other antibodies such as infusion reactions, fatigue, allergic responses, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My chondrosarcoma cannot be removed by surgery or has spread.

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My cancer can be measured by scans and has grown since any local treatments like radiation.

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My cancer has worsened in the last 6 months according to scans.

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I am fully active or can carry out light work.

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You are expected to live for at least 12 more weeks.

Timeline

Screening ~ 3 weeks0 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo

Secondary study objectives

Characterize the pharmacokinetics of INBRX-109.

DCR per RECISTv1.1 by real-time IRR

DOR per RECISTv1.1 by real-time IRR

+5 more

Other study objectives

Evaluate Quality of Life

ORR per RECISTv1.1 by Investigator assessment

PFS per RECISTv1.1 by Investigator assessment

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: INBRX-109Experimental Treatment1 Intervention

IV every three weeks

Group II: PlaceboPlacebo Group1 Intervention

IV every three weeks

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chondrosarcoma treatments often include surgery, radiation, and chemotherapy, though the latter is less effective due to the tumor's resistance. Targeted therapies, like INBRX-109, a DR5 agonist, work by inducing apoptosis in cancer cells. This is crucial for chondrosarcoma patients because traditional treatments are limited, and targeted therapies offer a more precise approach to eliminate cancer cells, potentially improving outcomes and reducing side effects.

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