INBRX-109 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, INBRX-109, to determine its effectiveness for certain solid tumors, including Ewing sarcoma and colorectal cancer. The main goal is to assess whether this drug is safe and effective in shrinking tumors or halting their growth. Participants may qualify if they have a solid tumor unresponsive to previous treatments and experience frequent symptoms or challenges in daily life due to their condition. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that you have not received any anticancer therapy within 4 weeks or within 5 half-lives prior to the first dose of the study treatment. This suggests you may need to stop certain medications before participating, but the protocol does not specify all medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that INBRX-109, a specially designed antibody, is under study to assess its safety for people. In earlier studies, patients with various solid tumors, such as sarcomas and other cancers, have tried this treatment to evaluate its effects. Although still in the early stages, the phase 1 trial focuses on understanding how well people tolerate INBRX-109 and identifying any possible side effects.
So far, these early trials have not consistently found major safety issues, but it's important to remember that the research is still in its early stages. Scientists are just beginning to collect detailed information about side effects. Participants often report common reactions like tiredness or mild discomfort, typical in early studies of new treatments. As a phase 1 trial, the main goal is to learn about the drug's safety and determine the right dosage.12345Why are researchers excited about this study treatment for solid tumors?
Unlike the standard of care for solid tumors, which often includes a mix of surgery, chemotherapy, and radiation, INBRX-109 stands out by specifically targeting death receptor 5 (DR5) on cancer cells. This unique mechanism of action is believed to trigger cancer cell death more directly, potentially leading to better outcomes. Researchers are excited about INBRX-109 because it can be combined with other chemotherapy agents, like irinotecan and temozolomide, to potentially enhance its effectiveness against tough cancers like Ewing Sarcoma and various adenocarcinomas. This versatility and targeted approach offer hope for more effective treatments with possibly fewer side effects.
What evidence suggests that this trial's treatments could be effective for solid tumors?
Research shows that INBRX-109 holds promise for treating different solid tumors. In this trial, participants with colorectal cancer will receive INBRX-109 combined with FOLFIRI chemotherapy, which studies have shown to lead to high response rates and good disease control. For Ewing sarcoma, participants will receive INBRX-109 with irinotecan and temozolomide, with early results indicating tumor shrinkage. Participants with malignant pleural mesothelioma will receive INBRX-109 alongside various chemotherapies, significantly decreasing the risk of disease progression. In other arms, participants with stomach and pancreatic cancers will receive INBRX-109, which has shown encouraging results. Overall, INBRX-109 targets the DR5 receptor, aiding in the destruction of cancer cells and showing potential across various solid tumors.678910
Who Is on the Research Team?
Clinical Lead
Principal Investigator
Inhibrx Biosciences, Inc
Are You a Good Fit for This Trial?
This trial is for adults with advanced or inoperable solid tumors, including various sarcomas and specific cancers like mesothelioma and pancreatic adenocarcinoma. Participants must have tried standard treatments without success or have no beneficial standard options available. They should be physically able to perform daily activities (with some limitations) and have their major organs functioning well. People with recent severe liver disease, infections needing antibiotics, prior DR5 agonist exposure, other cancer treatments within the last month, certain heart conditions, or known sensitivity to the study drugs cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
Combination Expansion
Subjects with specific cancer types will be treated with INBRX-109 in combination with various chemotherapies.
Single-Agent Expansion
Subjects with specific cancer types will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- INBRX-109
INBRX-109 is already approved in United States for the following indications:
- Chondrosarcoma (Orphan Drug Designation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inhibrx, Inc.
Lead Sponsor
Inhibrx Biosciences, Inc
Lead Sponsor