AzTrials
AzTrials

Endometrial CancerPhase 2NCT06463028

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer

A Phase 2 study testing Sapanisertib, Serabelisib and Paclitaxel in people with Endometrial Cancer, run by Faeth Therapeutics at 18 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Sapanisertib, Serabelisib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
18 sitesUnited States
Study dates
12 Dec 2024to Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of endometrioid endometrial carcinoma.
  • Documented evidence of advanced or recurrent endometrial cancer that is not amenable to surgery/radiation for curative intent.
  • Participant has received at least 1 but not more than 4 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination. If a subject has been unable to be treated with checkpoint inhibitor in the past due to medical contraindications, consult with Medical Monitor.
  • PI3K/AKT/mTOR pathway gene alteration identified.
  • At least 1 measurable target lesion according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.
  • Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods..

Who cannot join

  • Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study
  • Active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.
  • Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.
  • Clinically significant (per Investigator judgement) hemoptysis or tumor bleeding.
  • Significant cardiovascular impairment.
  • Active, uncontrolled (requiring systemic antimicrobial therapy) infection.
Show all 12Show fewer
  • Concurrent participation in another therapeutic clinical trial.
  • Prior radiation therapy within 21 days prior to start of study treatment.
  • Strong CYP3A4 inhibitors and inducers are prohibited during the study. Strong CYP1A2 inhibitors as well as CYP1A2 inducers should be administered with caution and at the discretion of the Investigator. Alternative treatments, if available, should be considered. Additionally, strong CYP3A4 inhibitors or inducers should not be taken within 7 days before the first dose of study intervention.
  • Participants who require PPIs or chronic use of antacids, histamine H2 receptor blockers, or other treatments to raise gastric pH.
  • Prolongation of QTc interval to >480 ms.
  • HbA1c ≥ 8.0% or fasting serum glucose > 160 mg/dL or fasting triglycerides > 300 mg/dL or receiving treatment with insulin.

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Medical Monitor contact

(708)406-9282

clinicaltrials@faeththerapeutics.com

18 sites in 1 country

United States18 sites, 18 recruiting

  • Women's Cancer Care Associates, LLC

    Albany, New York, 12208

    Recruiting

  • Maryland Oncology Hematology, P.A.

    Brandywine, Maryland, 20613

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 46214

    Recruiting

  • Alliance Cancer Specialists, PC

    Doylestown, Pennsylvania, 18901

    Recruiting

  • Texas Oncology - West Texas

    El Paso, Texas, 79902

    Recruiting

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

    Recruiting

  • Virginia Cancer Specialists, P.C.

    Fairfax, Virginia, 22031

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Maple Grove, Minnesota, 55369

    Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

    Recruiting

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94158

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Florida Cancer Specialists, North

    St. Petersburg, Florida, 33705

    Recruiting

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas, 77380

    Recruiting

  • Florida Cancer Specialists, East

    West Palm Beach, Florida, 33401

    Recruiting

Other trials in United States

About this study

Official title: An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus an Insulin-Suppressing Diet, in Patients With Advanced or Recurrent Endometrial Cancer

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.

Read the detailed description

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer who have failed prior systemic therapies, including a platinum-based therapy and an immune checkpoint inhibitor, either separately or together.

Being tested
Sapanisertib, Serabelisib, Paclitaxel
Keywords
Serabelisib, Sapanisertib, Paclitaxel, Taxol, Antineoplastic Agents, PI3K, AKT, mTOR, Dual PI3K/mTOR inhibition, Genetic mutation, Cisplatin, Carboplatin, Genital Diseases, Endometrial Neoplasms, Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma, Metastatic Endometrial Carcinoma, Endometrial Cancer, Endometrioid Carcinoma, Cancer of Endometrium
Medical subject headings
Endometrial Neoplasms, Genital Diseases, Carcinoma, Endometrioid, Hereditary Sensory and Autonomic Neuropathies

What participants receive

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

  • SapanisertibDrug

    Also called FTH-003, MLN0128

    Oral

  • SerabelisibDrug

    Also called FTH-001, MLN1117

    Oral

  • PaclitaxelDrug

    Infusion

Study groups in NCT06463028
Study groupRoleWhat they receive
sapanisertib and serabelisib (PIKTOR) with paclitaxelExperimentalSubjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.
Receives: Drug: Sapanisertib; Drug: Serabelisib; Drug: Paclitaxel

What is being measured

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

  1. Objective Response Rate (ORR)

    Defined as the proportion of participants with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR).

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Progression free survival (PFS)

    Defined as the time from first dose until the date of disease progression or death.

    Measured: Up to 5 years.

  2. Progression free survival (PFS) at 6 months

    Defined as PFS rate at 6 months.

    Measured: Up to 5 years.

  3. Overall survival (OS)

    Defined as the time from first dose to death.

    Measured: Up to 5 years.

  4. Clinical benefit rate (CBR)

    Defined as the percentage of participants who achieve complete response (CR), partial response (PR), or have stable disease (SD) of at least 16 or 24 weeks.

    Measured: Up to 5 years.

  5. Duration of response (DoR)

    Defined for participants with confirmed CR or PR as the time from response until date of documented disease progression or death.

    Measured: Up to 5 years.

  6. Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)

    Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).

    Measured: Up to 2 years.

Timeline

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

  1. First posted17 Jun 2024
  2. Study start12 Dec 2024
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2029 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06463028
Sponsor's protocol ID
FTH-PIK-201
Other IDs
GOG-3111
Status last verified
Dec 2025
First submitted
11 Jun 2024
Last updated
24 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Starks DC, Rojas-Espaillat L, Meissner T, Williams CB. Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors. Gynecol Oncol. 2022 Sep;166(3):403-409. doi: 10.1016/j.ygyno.2022.07.005. Epub 2022 Jul 15.

    PubMed 35843739

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sapanisertib, Serabelisib and Paclitaxel in people with Endometrial Cancer, run by Faeth Therapeutics at 18 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Medical Monitor ((708)406-9282, clinicaltrials@faeththerapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 2 years). 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 NCT06463028, which also lists 1 linked publication.

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 24 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in