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Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer

A Phase 1/2 Multi-center Investigation of ABI-009 (Nab-rapamycin) in Combination With FOLFOX and Bevacizumab as First-line Therapy in Patients With Advanced or Metastatic Colorectal Cancer

NCT03439462•Aadi Bioscience, Inc.

View on ClinicalTrials.gov

Summary

A phase 1/2 multi-center investigation of nab-sirolimus (also known as ABI-009, nab-rapamycin) in combination with mFOLFOX6 and Bevacizumab as first-line therapy in patients with metastatic colorectal cancer

Detailed Description

This study is a prospective phase 1/2, single arm, open-label, multi-institutional study to identify the RP2D and determine the efficacy and safety profile of nab-sirolimus administered as first-line therapy in combination with mFOLFOX6 and bevacizumab in patients with metastatic colorectal cancer.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with histologically confirmed advanced or metastatic colorectal cancers for whom chemotherapy is indicated.
•2. Patients must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
•3. Patients must have at least 1 measurable site of disease according to RECIST v1.1 that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be radiological evidence of progression since the radiation.
•4. Eligible patients, 18 years or older, with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
•5. Patients must not have been previously treated with an mTOR inhibitor.
•6. Adequate liver function:
•1. Total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dL
•2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (\<5 x ULN if the patient has liver metastases).
•7. Adequate renal function:
•a. Serum creatinine ≤2 x ULN or creatinine clearance \>50 cc/hr (Cockroft-Gault).
+13 more criteria

Exclusion Criteria

•1. History of severe and uncontrolled allergic reactions to bevacizumab
•2. Prior treatment with FOLFOX or bevacizumab within the preceding 4 weeks
•3. Patients currently receiving or have received anticancer therapies within 4 weeks of the start of study treatment (including chemotherapy, radiation therapy, antibody based therapy, etc.)
•4. Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
•5. Chronic treatment with systemic steroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
•6. Recent infection requiring systemic anti-infective treatment that was completed ≤14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).
•7. Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
•1. Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A patient with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases ≥28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
•2. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
•3. Pre-existing severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air (Note: spirometry and PFTs not required to be performed unless clinically indicated).
+9 more criteria

Locations (6)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Atlantic Health System/Morristown Medical Center

Morristown, New Jersey, United States

Baylor Scott and White University Medical Center

Dallas, Texas, United States

Seattle Cancer Care Alliance/University of Washington Medical Center

Seattle, Washington, United States

Key Dates

Start Date

July 1, 2018

Primary Completion Date

August 16, 2022

Completion Date

August 26, 2022

Last Updated

January 2, 2024

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer Metastatic

Interventions

nab-sirolimus

DRUG

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

NCT05759728

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COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer

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