Colon Cancer Clinical Trial

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Summary

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Escalation: Histologically or cytologically-confirmed advanced/metastatic or non-resectable solid tumors, including sarcoma, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma and certain sarcoma subtypes (e.g., chondrosarcoma, Ewing sarcoma), GIST, and SDH-def solid tumors with locally advanced or metastatic, non-resectable disease, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
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.

Exclusion Criteria:

Prior treatment with or exposure to DR5 agonists.
Receipt of investigational agents or devices, anticancer therapy and radiotherapy (with the exception of palliative localized radiation) within 4 weeks prior to the first dose of study drug, and liver-directed therapies (i.e., RFA, TACE/embolization, cryotherapy, SBRT) within 12 weeks prior to the first dose of study drug. Exceptions per protocol.
Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exception: Participants who have had a stem cell or bone marrow transplant > 5 years ago are eligible for enrollment, as long as there are no symptoms of graft-versus-host disease (GVHD).
Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-109.
Hematologic malignancies.
Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply.
Subjects with chronic liver diseases including but not limited to cirrhosis, NASH, alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatic or biliary autoimmune disorders (i.e., primary biliary cholangitis, autoimmune hepatitis).
Acute viral or toxic liver disease within 4 weeks prior to the first dose of study drug.
Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension. Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial.
Major surgery within 4 weeks prior to enrollment on this trial.
Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
Part 3: Sensitivity or contraindications to carboplatin, cisplatin, pemetrexed, fluorouracil, irinotecan, or temozolomide.

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

240

Study ID:

NCT03715933

Recruitment Status:

Recruiting

Sponsor:

Inhibrx, Inc.

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There are 15 Locations for this study

See Locations Near You

HonorHealth Research Institute
Scottsdale Arizona, 85258, United States More Info
Joyce Schaffer, RN
Contact
480-323-1791
mailto:[email protected]
Sunil Sharma, MD
Principal Investigator
City of Hope
Duarte California, 91010, United States More Info
Shamili Thiagarajan
Contact
626-218-0979
[email protected]
New Patient Services Coordinator
Contact
1-800-826-4673
[email protected]
Mark Agulnik, MD
Principal Investigator
Valkyrie Clinical Trials
Los Angeles California, 90067, United States More Info
Francisco Capilla
Contact
213-926-1844
[email protected]
David Berz, MD
Principal Investigator
Sarcoma Oncology Center
Santa Monica California, 90403, United States More Info
Victoria Chua-Alcala
Contact
310-552-9999
[email protected]
Sant P Chawla, MD
Principal Investigator
University of Colorado Hospital
Aurora Colorado, 80045, United States More Info
Ana Nguyen
Contact
720-848-4394
[email protected]
Christopher Lieu, MD
Principal Investigator
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States More Info
Suzanne Scott
Contact
404-778-4083
Maria Diab, MD
Principal Investigator
The University of Chicago
Chicago Illinois, 60637, United States More Info
Bianca Hill
Contact
773-834-1472
[email protected]
Buerkley Rose
Contact
773-834-4002
[email protected]
Hedy Kindler, MD
Principal Investigator
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Irina Veridyan
Contact
734-834-1512
[email protected]
Rashmi Chugh, MD
Principal Investigator
START Midwest Michigan, PC
Grand Rapids Michigan, 49546, United States More Info
Katie Robinson
Contact
616-389-1739
[email protected]
Nehal Lakhani, MD
Principal Investigator
Haley Phelan
New York New York, 10021, United States More Info
Haley C Phelan
Contact
646-888-6952
Ciara Kelly, MD
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Heather Kearney
Contact
216-444-3409
[email protected]
Dale Shepard, MD
Principal Investigator
University of Pennsylvania Abramson Cancer Center
Philadelphia Pennsylvania, 19106, United States More Info
Sarcoma Research
Contact
[email protected]
Lee Hartner, MD
Principal Investigator
UT MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Gita Dangol
Contact
713-792-2913
[email protected]
Vivek Subbiah, MD
Principal Investigator
NEXT Oncology
San Antonio Texas, 78229, United States
NEXT Oncology - Virginia
Fairfax Virginia, 22031, United States More Info
Melissa Hackmaster
Contact
[email protected]
Alexander Spira, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

240

Study ID:

NCT03715933

Recruitment Status:

Recruiting

Sponsor:


Inhibrx, Inc.

How clear is this clinincal trial information?

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