A Phase 1/2 interventional study of nab-sirolimus in Colorectal Cancer Metastatic, sponsored by Aadi Bioscience, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-01-02.
Sponsored by Aadi Bioscience, Inc. · Phase 1/2, Interventional, and Treatment
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
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's enrollment of 60 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Aadi Bioscience, Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate liver function:
Adequate renal function:
a. Serum creatinine ≤2 x ULN or >50 cc/hr (Cockroft-Gault).
Adequate biological parameters:
Male or non-pregnant and non-breast feeding female:
Exclusion Criteria:
Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: nab-sirolimus
nab-sirolimus combined with mFOLFOX6 + bevacizumab
Also known as: bevacizumab, mFOLFOX6
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
Time frame: 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.
Time frame: 6 months
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
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)
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.
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)
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.
Time frame: Through study completion (up to 50 months)
| Milestone | Dose Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 |
|---|---|---|---|
| Started | 6 | 10 | 44 |
| Completed | 6 | 10 | 44 |
| Not completed | 0 | 0 | 0 |
Dose-limiting-toxicities within the first 2 cycles of treatment with nab-sirolimus at various doses and schedule in combination with mFOLFOX6 and bevacizumab
| Participants | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 2: Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 | All Patients |
|---|---|---|---|---|
| Dose-limiting-toxicities (DLTs) (Phase 1) | 0 | 0 | 0 | 0 |
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.
| percentage of patients | All Efficacy Evaluable Patients | RP2D (Cohort 3): Nab-Sirolimus 20 mg/m2 qw2/4 | PTEN Positive | PTEN Negative |
|---|---|---|---|---|
| Progression-free Survival at 6 Months (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative) | 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) |
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
| percentage of efficacy analysis patients | All Patients | RP2D (Cohort 3): Nab-Sirolimus 20 mg/m2 qw2/4 | PTEN Positive | PTEN Negative |
|---|---|---|---|---|
| Disease Control Rate (DCR) (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative) | 78.6 (65.6 to 88.4) | 75.6 (59.7 to 87.6) | 79.5 (63.5 to 90.7) | 83.3 (51.6 to 97.9) |
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.
| Month | All Patients | RP2D (Cohort 3): Nab-Sirolimus 20 mg/m2 qw2/4 | PTEN Positive | PTEN Negative |
|---|---|---|---|---|
| Median Progression-free Survival (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative) | 10.9 (8.5 to 15.7) | 10.9 (7.3 to 14.5) | 13.1 (9.2 to 19.8) | 10.4 (5.5 to 22.4) |
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.
| percentage of efficacy analysis patients | All Patients | RP2D (Cohort 3): Nab-Sirolimus 20 mg/m2 qw2/4 | PTEN Positive | PTEN Negative |
|---|---|---|---|---|
| Overall Response Rate (Phase 2) for All Patients, at the RP2D, as Well as Based on PTEN Status (Positive and Negative) | 39.3 (26.5 to 53.2) | 36.6 (22.1 to 53.1) | 43.6 (27.8 to 60.4) | 41.7 (15.2 to 72.3) |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4 | 1/10 (10%) | 2/10 (20%) | 9/10 (90%) |
| Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 | 3/44 (6.8%) | 5/44 (11.4%) | 44/44 (100%) |
| Total | 4/60 (6.7%) | 7/60 (11.7%) | 59/60 (98.3%) |
| Event | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 | Total |
|---|---|---|---|---|
| ColitisGastrointestinal disorders | 0/6 | 1/10 | 0/44 | 1/60 |
| PneumoniaInfections and infestations | 0/6 | 1/10 | 0/44 | 1/60 |
| Decreased appetiteMetabolism and nutrition disorders | 0/6 | 0/10 | 2/44 | 2/60 |
| Enterocolitis infectiousGastrointestinal disorders | 0/6 | 0/10 | 1/44 | 1/60 |
| Rectal perforationGastrointestinal disorders | 0/6 | 0/10 | 1/44 | 1/60 |
| StomatitisGastrointestinal disorders | 0/6 | 0/10 | 1/44 | 1/60 |
| Event | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4 | Total |
|---|---|---|---|---|
| Myelosuppression (Thrombocytopenia)Blood and lymphatic system disorders | 5/6 | 4/10 | 13/44 | 22/60 |
| Myelosuppression (Anemia)Blood and lymphatic system disorders | 5/6 | 3/10 | 8/44 | 16/60 |
| MucositisGastrointestinal disorders | 4/6 | 5/10 | 31/44 | 40/60 |
| FatigueGeneral disorders | 4/6 | 5/10 | 26/44 | 35/60 |
| Myelossupression (Neutropenia)Blood and lymphatic system disorders | 4/6 | 5/10 | 9/44 | 18/60 |
| Weight decreasedInvestigations | 4/6 | 2/10 | 10/44 | 16/60 |
| DiarrheaGastrointestinal disorders | 3/6 | 5/10 | 15/44 | 23/60 |
| NauseaGastrointestinal disorders | 1/6 | 5/10 | 15/44 | 21/60 |
| Decreased appetiteMetabolism and nutrition disorders | 3/6 | 2/10 | 10/44 | 15/60 |
| RashSkin and subcutaneous tissue disorders | 3/6 | 5/10 | 18/44 | 26/60 |
The safety analysis set includes all treated patients
| Age, Categorical(Participants) | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 1: Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 2: Nab-Sirolimus 20 mg/m2 qw2/4 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 9 | 34 | 47 |
| >=65 years | 2 | 1 | 10 | 13 |
| Age, Continuous(Years) | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 1: Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 2: Nab-Sirolimus 20 mg/m2 qw2/4 | Total |
|---|---|---|---|---|
| Median | 61.5 (49 to 72) | 46.0 (34 to 71) | 51.0 (28 to 78) | 51.0 (28 to 78) |
| Sex: Female, Male(Participants) | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 1: Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 2: Nab-Sirolimus 20 mg/m2 qw2/4 | Total |
|---|---|---|---|---|
| Female | 1 | 5 | 17 | 23 |
| Male | 5 | 5 | 27 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 1: Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 2: Nab-Sirolimus 20 mg/m2 qw2/4 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 5 | 8 | 41 | 54 |
| Unknown or Not Reported | 1 | 2 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 1: Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 2: Nab-Sirolimus 20 mg/m2 qw2/4 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 0 | 1 | 3 | 4 |
| White | 6 | 7 | 36 | 49 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 4 | 6 |
| Region of Enrollment(participants) | Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4 | Cohort 1: Nab-Sirolimus 20 mg/m2 qw3/4 | Cohort 2: Nab-Sirolimus 20 mg/m2 qw2/4 | Total |
|---|---|---|---|---|
| United States | 6 | 10 | 44 | 60 |
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Studies of the drug tested here: Sirolimus Albumin-bound Nanoparticles
Aadi Bioscience, Inc.