Colorectal Cancer MetastaticPhase 1/2NCT03439462

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

A Phase 1/2 study testing nab-sirolimus in people with Colorectal Cancer Metastatic, run by Aadi Bioscience, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Colorectal Cancer Metastatic
What is being tested?: nab-sirolimus
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 6 sitesUnited States
Study dates: 1 Jul 2018to 26 Aug 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with histologically confirmed advanced or metastatic colorectal cancers for whom chemotherapy is indicated.
Patients must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
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.
Eligible patients, 18 years or older, with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Patients must not have been previously treated with an mTOR inhibitor.
Adequate liver function:

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Total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (<5 x ULN if the patient has liver metastases).
Adequate renal function:
Serum creatinine ≤2 x ULN or creatinine clearance >50 cc/hr (Cockroft-Gault).
Adequate biological parameters:
Absolute neutrophil count (ANC) ≥1.5 × 109/L
Platelet count ≥100,000/mm3 (100 × 109/L)
Hemoglobin ≥9 g/dL.
Fasting serum triglyceride ≤300 mg/dL; fasting serum cholesterol ≤350 mg/dL.
INR and PTT <1.5 x ULN (anticoagulation is allowed if target INR <1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks at time of enrollment).
Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy, and ≥6 months since adjuvant FOLFOX therapy (adequately recovered from the acute toxicities of any prior therapy, including neuropathy should be grade ≤1).
Male or non-pregnant and non-breast feeding female:
Females of child-bearing potential must agree to use effective contraception without interruption from 28 days prior to starting IP throughout 3 months after last dose of IP and have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.
Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and throughout 3 months after last dose of IP. A second form of birth control is required even if he has undergone a successful vasectomy.
Life expectancy of >3 months, as determined by the investigator.
Ability to understand and sign informed consent.
Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.

Who cannot join

History of severe and uncontrolled allergic reactions to bevacizumab
Prior treatment with FOLFOX or bevacizumab within the preceding 4 weeks
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.)
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
Chronic treatment with systemic steroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
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).

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Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
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.
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
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).
Uncontrolled diabetes as defined by fasting serum glucose >1.5x ULN or by HbA1c >8% despite adequate therapy.
Any active (acute or chronic) or uncontrolled infection/ disorders.
Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy. Note, controlled non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, or other adequately treated carcinoma-in-situ may be eligible, after documented discussion with the sponsor / medical monitor.
Known liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
A known history of HIV seropositivity.
Active Hepatitis B or Hepatitis C. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose Coumadin).
Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Baylor Scott and White University Medical Center
Dallas, Texas, 75246
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Atlantic Health System/Morristown Medical Center
Morristown, New Jersey, 07962
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Seattle Cancer Care Alliance/University of Washington Medical Center
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Colorectal Cancer Metastatic
Being tested: nab-sirolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nab-sirolimusDrug
Also called bevacizumab, mFOLFOX6
nab-sirolimus combined with mFOLFOX6 + bevacizumab

Study groups in NCT03439462
Study group	Role	What they receive
nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin)	Experimental	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 CRC. Receives: Drug: nab-sirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-limiting-toxicities (DLTs) (Phase 1)
Dose-limiting-toxicities within the first 2 cycles of treatment with nab-sirolimus at various doses and schedule in combination with mFOLFOX6 and bevacizumab
Measured: First 2 treatment cycles (2 months)
Progression-free Survival at 6 Months (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)
The PFS rate at 6 months was estimated using the Kaplan-Meier method for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). Progression-free survival was defined as the time from the first day of study drug administration to disease progression or death due to any cause. Response evaluation was performed per RECIST v1.1, with the criteria for progression is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: 6 months

Secondary outcomes (3)

Disease Control Rate (DCR) (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)
Disease control rate is defined as patients who achieved complete response, partial response, or stable disease and was summarized for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). Complete response and partial response required confirmation of response at the subsequent tumor assessment. Stable disease required a confirmatory assessment at a minimum interval of 8 weeks
Measured: Through study completion (up to 50 months)
Median Progression-free Survival (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)
The median PFS was estimated using the Kaplan-Meier method for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). Progression-free survival was defined as the time from the first day of study drug administration to disease progression or death due to any cause. Response evaluation was performed per RECIST v1.1, with the criteria for progression is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: Through study completion (up to 50 months)
Overall Response Rate (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)
The ORR was the proportion of patients who achieved a confirmed partial response or complete response per RECIST v1.1, and summarized for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). The ORR was reported along with exact 95% confidence intervals computed by the Clopper-Pearson method. Per RECIST v1.1, at each timepoint, objective tumor response for target lesions were assessed as such: Complete Response, disappearance of all target lesions, and pathological lymph nodes must have a reduction <10 mm; Partial Response, ≥30% decrease in the sum of the longest diameter of target lesions.
Measured: Through study completion (up to 50 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201826 Aug 2022

First posted20 Feb 2018
Study start1 Jul 2018
Primary completion16 Aug 2022
Study completion26 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03439462
Sponsor's protocol ID: COLO-007
Status last verified: Nov 2023
First submitted: 8 Feb 2018
Last updated: 2 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Cancer Metastatic trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03439462
Acronym / sponsor ID: COLO-007
Conditions: Colorectal Cancer Metastatic
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Aadi Bioscience, Inc.Industry (pharma, biotech, devices)
Study start: 1 Jul 2018 (actual)
Primary completion: 16 Aug 2022 (actual)
Study completion: 26 Aug 2022 (actual)
First posted: 20 Feb 2018 (actual)
Results: Posted 2 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin)	Experimental	Drug: nab-sirolimusSingle 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 CRC.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Patients with histologically confirmed advanced or metastatic colorectal cancers for whom chemotherapy is indicated.
Patients must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
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.
Eligible patients, 18 years or older, with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Patients must not have been previously treated with an mTOR inhibitor.

Key exclusion criteria (19 listed)

History of severe and uncontrolled allergic reactions to bevacizumab
Prior treatment with FOLFOX or bevacizumab within the preceding 4 weeks
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.)
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
Chronic treatment with systemic steroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nab-sirolimusAlso: bevacizumab, mFOLFOX6nab-sirolimus combined with mFOLFOX6 + bevacizumab	Drug	nab-sirolimus (also known as ABI-009, nab-rapamycin, albumin-bound rapamycin)

Primary outcome

Dose-limiting-toxicities (DLTs) (Phase 1)
Time frame: First 2 treatment cycles (2 months)
Dose-limiting-toxicities within the first 2 cycles of treatment with nab-sirolimus at various doses and schedule in combination with mFOLFOX6 and bevacizumab
Progression-free Survival at 6 Months (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)
Time frame: 6 months
The PFS rate at 6 months was estimated using the Kaplan-Meier method for a) all efficacy evaluable patients, b) patients receiving treatment at the RP2D, and c) based on PTEN status (positive or negative). Progression-free survival was defined as the time from the first day of study drug administration to disease progression or death due to any cause. Response evaluation was performed per RECIST v1.1, with the criteria for progression is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.

3 secondary outcomes

Disease Control Rate (DCR) (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)
Time frame: Through study completion (up to 50 months)
Median Progression-free Survival (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)
Time frame: Through study completion (up to 50 months)
Overall Response Rate (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)
Time frame: Through study completion (up to 50 months)

Results and safety

Results posted to the registry on 2 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4	6	6
Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4	10	10
Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4	44	44

Primary outcome: Dose-limiting-toxicities (DLTs) (Phase 1)

Time frame: First 2 treatment cycles (2 months). Count of participants. Unit: Participants

Measure	Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 n = 6	Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 n = 10	Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 n = 44	All Patients n = 60
Value	0	0	0	0

Primary outcome: Progression-free Survival at 6 Months (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative)

Time frame: 6 months. Number (95% Confidence Interval). Unit: percentage of patients

Measure	All Efficacy Evaluable Patients n = 56	RP2D (Cohort 3): Nab-Sirolimus 20 mg/m2 qw2/4 n = 41	PTEN Positive n = 39	PTEN Negative n = 12
Value	77.3 (63.5 to 86.5)	76.3 (59.2 to 86.9)	78.2 (61.0 to 88.5)	82.5 (46.1 to 95.3)

Population analysed: The Efficacy Analysis Set includes all patients at baseline who received ≥2 doses of nab-sirolimus and had ≥1 scan. Based on the statistical design of this Phase 1/2 study, the efficacy endpoints are analyzed together for All Efficacy Evaluable patients (n=56) and at the RP2D (n=41). The data for all efficacy evaluable patients was also prospectively evaluated based on PTEN status for those with available IHC results (positive or negative, n=39 and n=12, respectively).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety and tolerability was monitored through continuous reporting of treatment-emergent and treatment-related AEs, Serious AEs, laboratory abnormalities, and incidence of patients experiencing dose modifications, dose delay/dose not given, and/or premature discontinuation of study drugs due to an AE. All AEs will be recorded by the investigator from the time the patient signs informed consent until 28 days after the last dose of study drugs (up to 50 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4	2 of 10 (20%)	9 of 10 (90%)	1 of 10
Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4	5 of 44 (11.4%)	44 of 44 (100%)	3 of 44
Total	7 of 60 (11.7%)	59 of 60 (98.3%)	4 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nab-sirolimus in people with Colorectal Cancer Metastatic, run by Aadi Bioscience, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting-toxicities (DLTs) (Phase 1) (time frame: First 2 treatment cycles (2 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03439462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.