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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
Awards & highlights
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 belowSelect...
My chondrosarcoma cannot be removed by surgery or has spread.
Select...
My cancer can be measured by scans and has grown since any local treatments like radiation.
Select...
My cancer has worsened in the last 6 months according to scans.
Select...
I am fully active or can carry out light work.
Select...
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
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 moreOther study objectives
Evaluate Quality of Life
ORR per RECISTv1.1 by Investigator assessment
PFS per RECISTv1.1 by Investigator assessment
+1 moreTrial 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
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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Synergistic effects of BAY606583 on docetaxel in esophageal cancer through modulation of ERK1/2.Targeted Therapy of <i>TERT</i>-Rearranged Neuroblastoma with BET Bromodomain Inhibitor and Proteasome Inhibitor Combination Therapy.Activity of BET-proteolysis targeting chimeric (PROTAC) compounds in triple negative breast cancer.
Find a Location
Who is running the clinical trial?
Inhibrx, Inc.Lead Sponsor
8 Previous Clinical Trials
1,406 Total Patients Enrolled
1 Trials studying Chondrosarcoma
240 Patients Enrolled for Chondrosarcoma
Vasily Andrianov, MDStudy DirectorInhibrx, Inc.
4 Previous Clinical Trials
764 Total Patients Enrolled
1 Trials studying Chondrosarcoma
240 Patients Enrolled for Chondrosarcoma
Klaus Wagner, MD PhDStudy DirectorInhibrx, Inc.
1 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by scans and has grown since any local treatments like radiation.I am fully active or can carry out light work.Your doctor expects you to live for at least 12 more weeks.I have a history of multiple sclerosis or similar conditions.My cancer has worsened in the last 6 months according to scans.My chondrosarcoma cannot be removed by surgery or has spread.You are allergic to INBRX-109 or have known allergies to antibodies made from CHO cells.My chondrosarcoma cannot be removed by surgery or has spread.You are expected to live for at least 12 more weeks.I have been treated with DR5 agonists before.
Research Study Groups:
This trial has the following groups:- Group 1: INBRX-109
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chondrosarcoma Patient Testimony for trial: Trial Name: NCT04950075 — Phase 2
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