RECRUITING

First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

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Conditions

Breast CancerSolid Tumors, AdultBreast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesHER2-negative breast cancerHR-positive breast cancerGynecologic cancerEndometrial cancerOvarian cancerCervical cancerHead and neck cancerHead and neck squamous cell carcinomaFulvestrantAntineoplastic AgentsPI3KαPI3K alphaPI3Kα mutationAlpelisibSTX-478PI3Kα inhibitorEstrogen Receptor AntagonistsEstrogen AntagonistsHormone Receptor AntagonistsHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPalbociclibRibociclibPIK3CAPIK3CA mutationAromatase inhibitorLetrozoleAnastrozoleExemestaneImlunestrantInavolisibCapivasertib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.

Official Title

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Quick Facts

Study Start:2023-04-17
Study Completion:2030-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05768139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort)
  2. * Has a new or recent tumor biopsy (collected at screening, if feasible) or will provide an adequate tissue sample prior to screening
  3. * Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for cohort-specific mutation types)
  4. * Is ≥18 years of age at the time of signing the ICF
  5. * Has an ECOG performance status score of 0 or 1 at screening
  6. * Has adequate organ function as defined per protocol
  1. * Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied
  2. * Has symptomatic brain or spinal metastases
  3. * Has an established diagnosis of uncontrolled diabetes mellitus (defined as HbA1c ≥8% and/or FBG ≥140 mg/dL \[7.7 mmol/L\] and/or requiring or required insulin).
  4. * Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances
  5. * Has had treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to the initiation of study treatment up to a maximum washout period of 28 days. Endocrine therapy does not require a washout period if the patient is enrolling in a cohort with the same combination endocrine therapy.
  6. * Has toxicities from previous anticancer therapies that have not resolved to baseline levels or CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy.
  7. * Has had radiotherapy within 14 days before the initiation of study treatment

Contacts and Locations

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact
CONTACT
clinical_inquiry_hub@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

The Angeles Clinic & Research Institute
Los Angeles, California, 90025-6602
United States
UCSF Medical Center at Mission Bay
San Francisco, California, 94143
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida, 32746
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
United States
Massachusetts General Hospital
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111-3220
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246-2092
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
START San Antonio
San Antonio, Texas, 78229
United States
START Mountain Region
West Valley City, Utah, 84119
United States
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-17
Study Completion Date2030-07

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2030-07

Terms related to this study

Keywords Provided by Researchers

  • Breast Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Breast Diseases
  • HER2-negative breast cancer
  • HR-positive breast cancer
  • Gynecologic cancer
  • Endometrial cancer
  • Ovarian cancer
  • Cervical cancer
  • Head and neck cancer
  • Head and neck squamous cell carcinoma
  • Fulvestrant
  • Antineoplastic Agents
  • PI3Kα
  • PI3K alpha
  • PI3Kα mutation
  • Alpelisib
  • STX-478
  • PI3Kα inhibitor
  • Estrogen Receptor Antagonists
  • Estrogen Antagonists
  • Hormone Receptor Antagonists
  • Hormone Antagonists
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Physiological Effects of Drugs
  • Palbociclib
  • Ribociclib
  • PIK3CA
  • PIK3CA mutation
  • Aromatase inhibitor
  • Letrozole
  • Anastrozole
  • Exemestane
  • Imlunestrant
  • Inavolisib
  • Capivasertib

Additional Relevant MeSH Terms

  • Breast Cancer
  • Solid Tumors, Adult