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Advanced Solid TumorPhase 1NCT05300048

Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations

A Phase 1 study testing Serabelisib, Insulin Suppressing Diet and Nab paclitaxel in people with Advanced Solid Tumor and PIK3CA Mutation, run by Faeth Therapeutics at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Serabelisib, Insulin Suppressing Diet and Nab paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
17 sitesUnited States
Study dates
22 Apr 2022to 30 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written informed consent.
  • Age ≥18 at Visit -1 (screening).
  • Histologically or cytologically confirmed recurrent solid tumors.
  • Cohort 1a: any extracranial solid tumor (may include EC, ovarian clear cell, or ovarian endometrioid carcinoma if subject is not eligible for nab-paclitaxel in Cohort
  • 1b)
  • Cohort 1b: either recurrent or persistent endometrial adenocarcinoma (EC) with the following histologic epithelial cell types: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma, and carcinosarcoma or; ovarian cancer (OC) with the primary tumor having ≥ 50% clear cell histomorphology or ovarian clear cell or ovarian endometrioid carcinoma.
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  • Cohort 2: adenocarcinoma of the colon or rectum.
  • Cohort 3: recurrent or persistent endometrial adenocarcinoma with the following histologic epithelial cell types as described for Cohort 1b
  • Cohort 4: OC primary tumor carcinomas as described for Cohort 1b
  • Tumor must harbor an activating mutation in the PIK3CA gene with or without PTEN loss, either previously documented or determined during screening.
  • Fresh or archival tumor biopsy with sufficient material to be sent to the designated laboratory for PD analyses. For subjects who consent to future research, an additional 5 slides from a surgical specimen or biopsy is required.
  • Cohort 1a - Dose Modification (subjects with any solid tumor): failed, were intolerant of, or ineligible for no more than three prior lines of therapy (LOT) for advanced/metastatic disease or refused SOC therapy.
  • For all cohorts, in the unlikely scenario that a subject refused all available SOC they may proceed with trial. These subjects would be regarded as having 0 prior LOT.
  • Cohorts 1b, 2, 3, and 4 - failed, were intolerant of, ineligible for, or have refused SOC therapy for advanced/metastatic disease (AJCC stage III and IV) and:
  • Cohort 2 (subjects with colorectal cancer): Have failed no more than two prior LOT for metastatic CRC.
  • Cohort 1b, and Cohort 3 (subjects with EC): Have no more than three prior chemotherapeutic regimens for management of endometrial carcinoma (neo-adjuvant and/or adjuvant chemotherapy will be counted as one prior LOT). Prior hormonal therapy will not count as a systemic regimen.
  • Cohort 1b, and Cohort 4 (subjects with clear cell or endometrioid OC): Subjects must have had no more than three prior chemotherapeutic regimens for management of ovarian carcinoma. Prior hormonal therapy will not count as a systemic regimen.
  • Life expectancy of at least 3 months.
  • At least one measurable lesion (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
  • ECOG PS of 0 to 1.
  • Adequate organ function
  • Absolute neutrophil count (ANC) ≥1.0 × 10^9/L or ≥1.5 x 10^9/L if planned to be treated with nab-paclitaxel, platelet count ≥75 × 10^9/L, and hemoglobin ≥8.5 gm/dL (may be transfused to reach this hemoglobin level unless due to blood loss).
  • Liver transaminases (AST and ALT) ≤2.5 × upper limit of normal (ULN) (<5 × ULN if liver metastases are present), and total bilirubin ≤1.5 × ULN (<3 x ULN if subject has Gilbert Syndrome).
  • INR ≤1.5 x ULN unless subject is on anticoagulants that would affect the INR, then INR must be in the desired therapeutic range as judged by the Investigator.
  • Albumin level ≥3.0 mg/dL or ≥ the lower limit of normal.
  • Renal: Serum creatinine ≤2 x ULN
  • Ability to take PO medication, be willing to adhere to study procedures and Study Intervention administration, and receive, consume, and comply with Study ISD.
  • For women of child-bearing potential, a negative serum pregnancy test collected at screening (Visit-1) and negative urine pregnancy test collected at baseline (Visit-1) and use of physician-approved method of birth control from the time of the pregnancy test performed at screening to 90 days following the last administration of Study Drug or, if applicable, 6 months following the last administration of nab-paclitaxel.
  • Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 90 days following the last administration of Study Drug.

Who cannot join

  • Diagnosis of primary malignant brain tumor.
  • Has had serabelisib, alpelisib, or other PI3K inhibitor.
  • Leptomeningeal disease and symptomatic or untreated brain metastases.
  • Diagnosis of, or requiring treatment for, another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 90 days prior to the first dose of Study Drug).
  • Is less than 21 days from therapeutic radiation or chemotherapy prior to the first day of dosing with Study Drug and has not recovered to Grade ≤ 1 from all clinically significant toxicities related to prior therapies.
  • For subjects receiving nitrosoureas or mitomycin C, the subject is < 6 weeks from last dose. For monoclonal antibody therapy, the subject is < 1 half-life or <4 weeks from the last dose.
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  • Chronic, systemically administered glucocorticoids in doses equivalent to >5 mg prednisone daily. Replacement corticosteroids for adrenal insufficiency are permitted.
  • Diabetes mellitus requiring insulin or insulin secretagogue therapy.
  • Poorly controlled diabetes mellitus defined as glycosylated hemoglobin A1c (HbA1c) >7.5% or fasting blood sugar >160 mg/ dL.
  • Known impaired cardiac function or clinically significant cardiac disease.
  • QTcF interval >470 msec found at screening.
  • Myocardial infarction, cardiac stent placement, or unstable angina within 6 months before the first administration of Study Drug.
  • Have clinically significant peripheral vascular disease.
  • Manifestations of malabsorption
  • Other clinically significant comorbidities.
  • Pregnant (positive serum pregnancy test), planning to become pregnant during the study, or breastfeeding/planning to breastfeed during the study.
  • Have taken strong CYP3A4 inducers/inhibitors within 7 days before the first administration of serabelisib or have conditions that require the concomitant use of CYP3A4 inducers/inhibitors.
  • Untreated or poorly controlled, gastro-esophageal reflux disease.
  • Have taken histamine-H2 receptor antagonists within 12 hours before the first administration of serabelisib.
  • Have taken PPI within 7 days or 5 half-lives (whichever is the shorter duration) before the first administration of serabelisib or are anticipated to need PPI during the study.
  • Have taken neutralizing antacids within 4 hours before the first administration of serabelisib or are anticipated to need frequent antacid use during the study.
  • Subjects with poorly controlled human immunodeficiency virus, hepatitis B virus, and/or hepatitis C virus infections.
  • Known allergies to nab-paclitaxel or excipients, serabelisib or excipients or the ISD
  • Severe, uncontrolled gout.
  • A BMI <18.5 kg/m2, or serious or refractive cachexia or anorexia that, in the Investigator's opinion, realistically prohibits subjects from having energy or appetite sufficient to reliably engage in a strict ISD regimen for an extended time.
  • Any condition that renders the subject unable to satisfactorily chew, swallow, digest, or tolerate (i.e., persistent diarrhea) the majority of foods and liquids of the Study ISD.
  • History of severe nephrolithiasis requiring urologic intervention.
  • Participation in a diet or weight loss plan within 10 days prior to the first administration of Study Drug.
  • Severe constipation or condition where exacerbation of constipation is not advisable (eg, small bowel obstruction history).
  • History of anaphylaxis from food allergy or other disease state requiring avoidance of a particular food, such as celiac disease.
  • Diagnosed eating disorder in the past 10 years.
  • Unwilling to take a non-vegan or non-vegetarian diet.
  • Peripheral neuropathy ≥ CTC Grade 2

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Pacific Cancer Specialists

    Anaheim, California, 92801

  • Baptist Hospitals of Southeast Texas

    Beaumont, Texas, 77701

  • New Jersey Cancer Care, PA

    Belleville, New Jersey, 07109

  • University of Alabama

    Birmingham, Alabama, 35429

  • Englewood Health

    Englewood, New Jersey, 07631

  • East Carolina University

    Greenville, North Carolina, 27858

  • Oncology Consultants, PA

    Houston, Texas, 77030

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46250

  • Lumi Research

    Kingwood, Texas, 77339

  • Northwell Health

    Lake Success, New York, 11042

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • University of Pennsylvania Health System, Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55902

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

Other trials in United States

About this study

Official title: A Phase 1b Study of Serabelisib in Combination With an Insulin Suppressing Diet (Study ISD) and With or Without Nab-paclitaxel in Adult Subjects With Advanced Solid Tumors With PIK3CA Mutations With or Without PTEN Loss

This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.

Read the detailed description

Targeted anticancer drugs have side effects that often result in a poor quality of life, noncompliance, dose decreases, or discontinuation, all of which can affect efficacy. This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib when combined with an insulin suppressing diet and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.

Being tested
Serabelisib, Insulin Suppressing Diet, Nab paclitaxel
Keywords
PIK3CA Mutation, PTEN Loss of Function Mutation

What participants receive

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

  • SerabelisibDrug

    serabelisib administered orally

  • Insulin Suppressing DietOther

    3 meals consumed daily (i.e., breakfast, lunch, dinner) and optional snacks provided dependent on caloric needs

  • Nab paclitaxelDrug

    nab-paclitaxel administered intravenously weekly

Study groups in NCT05300048
Study groupRoleWhat they receive
Cohort 1a - Dose Modification without nab-paclitaxelExperimentalSubjects with any solid tumor will receive multiple doses of serabelisib administered orally and will consume Insulin Suppressing Diet for up to 12 months
Receives: Drug: Serabelisib; Other: Insulin Suppressing Diet
Cohort 1b - Dose Modification with Nab-PaclitaxelExperimentalSubjects with endometrial cancer, ovarian clear cell or ovarian endometriod carcinoma will receive multiple doses of serabelisib administered orally and will consume Insulin Suppressing Diet for up to 12 months. In addition, these subjects will receive nab-paclitaxel intravenously weekly.
Receives: Drug: Serabelisib; Other: Insulin Suppressing Diet; Drug: Nab paclitaxel
Cohort 2 - Expansion Colorectal CancerExperimentalSubjects will receive dose of serabelisib as determined from Cohort 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months
Receives: Drug: Serabelisib; Other: Insulin Suppressing Diet
Cohort 3 - Expansion Endometrial CancerExperimentalSubjects will receive dose of serabelisib as determined from Cohort 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months. If results from Cohort 1b show a favorable risk-benefit ratio, nab-paclitaxel will be administered intravenously weekly.
Receives: Drug: Serabelisib; Other: Insulin Suppressing Diet; Drug: Nab paclitaxel
Cohort 4 - Expansion Ovarian Clear Cell or Ovarian Endometrioid CarcinomaExperimentalSubjects will receive dose of serabelisib as determined from Cohorts 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months. If results from Cohort 1b show a favorable risk-benefit ratio, nab-paclitaxel will be administered intravenously weekly.
Receives: Drug: Serabelisib; Other: Insulin Suppressing Diet; Drug: Nab paclitaxel

What is being measured

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

  1. Cohorts 1a/1b: Evaluate safety

    Incidence of related AEs

    Measured: Through study completion, up to 12 months.

  2. Cohorts 1a/1b: Evaluate compliance

    Compliance of Study intervention

    Measured: Through study completion, up to 12 months.

  3. Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Cmax.

    Standard pharmacokinetic parameters (Cmax)

    Measured: Through study completion, up to 12 months.

  4. Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring Tmax.

    Standard pharmacokinetic parameters (Tmax).

    Measured: Through study completion, up to 12 months.

  5. Cohorts 1a/1b: Evaluate the pharmacokinetic impact by measuring AUC.

    Standard pharmacokinetic parameters (AUC).

    Measured: Through study completion, up to 12 months.

  6. Cohorts 2, 3, 4: Use the Objective Response Rate (ORR) to assess the antitumor efficacy of serabelisib in combination with a Study ISD.

    Proportion of subjects who have best overall response of either complete response (CR) or partial response (PR)

    Measured: Through study completion, an average of 8 months.

Secondary outcomes (15)

  1. Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring ORR.

    Proportion of subjects who have best overall response of either CR or PR, as determined by each site.

    Measured: Through study completion, up to 12 months.

  2. Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring PFS.

    Time from date of first dose of Study Drug (Visit 1) to the date of first evidence of disease progression or death from any cause (whichever occurs first).

    Measured: Through study completion, up to 12 months.

  3. Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring OS.

    Overall survival (OS) and landmark survival.

    Measured: Through study completion, up to 12 months.

  4. Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring DoR.

    Duration of response (DoR)

    Measured: Through study completion, up to 12 months.

  5. Cohorts 1a/1b: Antitumor efficacy of study intervention by measuring DCR.

    Disease control rate (DCR; CR + PR + stable disease [SD])

    Measured: Through study completion, up to 12 months.

  6. Cohort 2, 3, 4: Confirm safety

    Incidence of related AEs

    Measured: Through study completion, up to 12 months.

  7. Cohort 2, 3, 4: Confirm the compliance of study intervention.

    Compliance of Study intervention

    Measured: Through study completion, up to 12 months.

  8. Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring PFS).

    Time from the date of first dose of Study Drug (Visit 1) to the date of first evidence of disease progression or death from any cause (whichever occurs first)

    Measured: Through study completion, up to 12 months.

  9. Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring OS).

    OS and landmark survival

    Measured: Through study completion, up to 12 months.

  10. Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring DoR).

    DoR

    Measured: Through study completion, up to 12 months.

  11. Cohort 2, 3, 4: Additional assessments of antitumor efficacy of study intervention (Measuring DCR).

    DCR (CR+PR+SD)

    Measured: Through study completion, up to 12 months.

  12. Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.

    Standard PK Parameters (Cmax) in plasma.

    Measured: Through study completion, up to 12 months.

  13. Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.

    Standard PK Parameters (Tmax) in plasma

    Measured: Through study completion, up to 12 months.

  14. Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.

    Standard PK Parameters (AUC) in plasma

    Measured: Through study completion, up to 12 months.

  15. Cohort 2, 3, 4: Assess the population PK and intra-tumoral concentration of study intervention.

    Serabelisib concentration in tumor tissue

    Measured: Through study completion, up to 12 months.

Timeline

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

  1. First posted29 Mar 2022
  2. Study start22 Apr 2022
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Why it stopped: Program prioritization

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05300048
Sponsor's protocol ID
SER-ISD1-001
Status last verified
Apr 2026
First submitted
31 Jan 2022
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Serabelisib, Insulin Suppressing Diet and Nab paclitaxel in people with Advanced Solid Tumor and PIK3CA Mutation, run by Faeth Therapeutics at 17 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 29 inclusion and 33 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: stopped early, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 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.

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

Are results available for this study?

The study was stopped early (reason given: Program prioritization). Results are not available in the source record.

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?

Cohorts 1a/1b: Evaluate safety (time frame: Through study completion, up to 12 months.). The study lists 6 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 NCT05300048.

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 30 Apr 2026.

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