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Monoclonal Antibodies

INBRX-109 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Inhibrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females aged ≥12 to <85 years for Ewing sarcoma and 18 to <85 years of age for GIST
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 for Part 1 and ECOG PS of 0, 1 or 2 for Parts 2 and 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new drug, INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5). This is the first time this drug is being tested in humans. The trial has three parts.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing INBRX-109, a new antibody targeting death receptor 5 on cancer cells. It's given alongside existing chemotherapy drugs: carboplatin, cisplatin, pemetrexed, fluorouracil (5-FU), irinotecan, and temozolomide. The study has three parts but isn't randomizing patients; instead it progressively includes more participants as safety data emerges.See study design
What are the potential side effects?
Possible side effects of INBRX-109 may include reactions at the infusion site and symptoms related to immune activation such as fever or fatigue. Chemotherapy can cause nausea/vomiting, hair loss, blood cell count changes leading to increased infection risk or bleeding problems; kidney/liver function changes; nerve damage causing numbness/tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 84 years old with Ewing sarcoma, or 18 and 84 with GIST.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of adverse events of INBRX-109
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109
Secondary outcome measures
Area under the serum concentration time curve (AUC) of INBRX-109
Immunogenicity of INBRX-109
Maximum observed serum concentration (Cmax) of INBRX-109
+2 more
Other outcome measures
Anti-tumor activity of INBRX-109

Trial Design

11Treatment groups
Experimental Treatment
Group I: Expansion Solid TumorsExperimental Treatment1 Intervention
Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Group II: Expansion SarcomasExperimental Treatment1 Intervention
Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Group III: Expansion Malignant Pleural MesotheliomaExperimental Treatment1 Intervention
Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Group IV: Expansion Gastric AdenocarcinomaExperimental Treatment1 Intervention
Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Group V: Expansion Colorectal AdenocarcinomaExperimental Treatment1 Intervention
Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Group VI: Dose EscalationExperimental Treatment1 Intervention
INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
Group VII: Combination Expansion SDH-deficient solid tumors or GISTExperimental Treatment2 Interventions
Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
Group VIII: Combination Expansion Pancreatic AdenocarcinomaExperimental Treatment3 Interventions
Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
Group IX: Combination Expansion Malignant Pleural MesotheliomaExperimental Treatment4 Interventions
Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
Group X: Combination Expansion Ewing SarcomaExperimental Treatment3 Interventions
Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Group XI: Combination Expansion Colorectal AdenocarcinomaExperimental Treatment3 Interventions
Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
5-fluorouracil
2005
Completed Phase 4
~7960
Irinotecan
2017
Completed Phase 4
~2680
Temozolomide
2010
Completed Phase 3
~1930
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250

Find a Location

Who is running the clinical trial?

Inhibrx, Inc.Lead Sponsor
8 Previous Clinical Trials
1,507 Total Patients Enrolled
Vasily Andrianov, MDStudy DirectorInhibrx, Inc.
4 Previous Clinical Trials
865 Total Patients Enrolled
Josep Garcia, PhDStudy DirectorInhibrx, Inc.
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

INBRX-109 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03715933 — Phase 1
Sarcoma Research Study Groups: Combination Expansion Malignant Pleural Mesothelioma, Expansion Malignant Pleural Mesothelioma, Expansion Gastric Adenocarcinoma, Dose Escalation, Combination Expansion Pancreatic Adenocarcinoma, Expansion Colorectal Adenocarcinoma, Expansion Sarcomas, Combination Expansion SDH-deficient solid tumors or GIST, Combination Expansion Ewing Sarcoma, Combination Expansion Colorectal Adenocarcinoma, Expansion Solid Tumors
Sarcoma Clinical Trial 2023: INBRX-109 Highlights & Side Effects. Trial Name: NCT03715933 — Phase 1
INBRX-109 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03715933 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the extent of the geographic scope for this clinical trial?

"This study is being run in multiple locations, with Heather Keaney leading the charge at New york's centre, Memorial Sloan Kettering Cancer Center located in Scottsdale and HonorHealth Research Institute based out of Chicago. A further 14 sites are also taking part."

Answered by AI

What applications does INBRX-109 have in medical treatments?

"INBRX-109 is frequently used to treat initial stages of cancer. Additionally, it can be employed as a therapeutic agent for patients suffering from small cell lung cancer (sclc), advanced testicular cancers, and progression disease."

Answered by AI

Has INBRX-109 been explored in any other clinical experiments?

"INBRX-109 was initially investigated in 1997 by City of Hope Comprehensive Cancer Center. Currently, there are 2742 concluded studies and 1681 active trials happening at multiple sites around New york City."

Answered by AI

Has INBRX-109 attained regulatory authorization from the U.S. Food and Drug Administration?

"Our team at Power have assigned the safety of INBRX-109 a score of 1, in accordance with its status as an initial Phase 1 trial. This indicates that there is only limited information around both efficacy and safety."

Answered by AI

Approximately how many participants have been recruited for this trial?

"Inhibrx, Inc., the sponsor of this study, requires a total of 240 participants that conform to the inclusion criteria. The research will be conducted at Heather Keaney in New york and Memorial Sloan Kettering Cancer Center in Arizona."

Answered by AI

Are there any opportunities for individuals to sign up and participate in this research?

"Correct. Clinicaltrials.gov reveals that this research project, first posted on October 10th 2018, is actively seeking participants for recruitment. A total of 240 patients are required from 16 separate medical centres."

Answered by AI

What objectives is this research venture hoping to realize?

"This two-year clinical trial is designed to assess the intensity and frequency of any adverse reactions associated with INBRX-109. In addition, immunogenicity, peak serum concentration (Cmax) and trough observed serum concentration (Ctrough) for this medication will be measured as secondary outcomes."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Emory University - Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I am hoping for a cure for the type of cancer I have, I hope it can save me and if not perhaps the research can help save others in the future, thank you.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
2018. "Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03715933.
All > Colorectal Cancer Glendale > Chondrosarcoma
~54 spots leftby Dec 2025
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