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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests tersolisib (STX-478) alone or with other cancer drugs in adults with advanced solid tumors that have a PI3Kα gene change. It looks at safety, how the body handles the drug, and whether it helps fight cancer. The drug combinations are for people with breast cancer that uses hormones to grow.

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, tamoxifen, 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older when signing the consent form.
  • Have a solid tumor that has spread or grown nearby and cannot be removed by surgery, as required for the study group.
  • Provide a new or recent tumor biopsy, if possible, or a suitable stored tumor tissue sample before screening.
  • Have a confirmed PI3Kα gene change in the tumor that meets the study group's rules.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have organs that work well enough under the study rules.

Who can't join

  • Had a different type of solid tumor or blood cancer within 2 years before screening.
  • Have cancer that has spread to the brain or spine and causes symptoms.
  • Have uncontrolled diabetes: an HbA1c blood sugar test of 8% or higher, fasting blood sugar of 140 mg/dL or higher, or a need for insulin now or in the past.
  • Previously took drugs that block PI3K, AKT, or mTOR, with some exceptions.
  • Had cancer treatment too recently. The waiting period is at least 14 days and may be up to 28 days, based on how long the drug stays in the body. No wait is needed for hormone therapy if continuing the same hormone drug combination in the study.
  • Still have side effects from past cancer treatment that are worse than mild or have not returned to earlier levels. Hair loss and nerve damage in the hands or feet are exceptions.
  • Had radiation treatment within 14 days before starting study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort) * Has a new or recent tumor biopsy (collected at screening, if feasible) or will provide an adequate tissue sample prior to screening * Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for cohort-specific mutation types) * Is ≥18 years of age at the time of signing the ICF * Has an ECOG performance status score of 0 or 1 at screening * Has adequate organ function as defined per protocol Key Exclusion Criteria: * Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied * Has symptomatic brain or spinal metastases * 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). * Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances * 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. * 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. * Has had radiotherapy within 14 days before the initiation of study treatment

Study sites (28)

CA

CO

  • University of Colorado Cancer Center · Aurora, CO 80045Anthony Elias · Principal investigatorMore trials in Aurora

CT

FL

GA

  • Winship Cancer Institute, Emory University · Atlanta, GA 30322Manali Bhave · Principal investigatorMore trials in Atlanta

IA

LA

  • Louisiana State University Health Sciences Center · New Orleans, LA 70112Shou-Ching Tang · Principal investigatorMore trials in New Orleans

MA

  • Massachusetts General Hospital · Boston, MA 02115Dejan Juric · Principal investigatorMore trials in Boston
  • Dana-Farber Cancer Institute · Boston, MA 02215Antonio Giordano · Principal investigatorMore trials in Boston

MI

MO

NY

  • Memorial Sloan Kettering Cancer Center · New York, NY 10065Komal Jhaveri · Principal investigatorMore trials in New York

OH

  • UH Cleveland Medical Center · Cleveland, OH 44106Alberto Montero · Principal investigatorMore trials in Cleveland
  • Stefanie Spielman Comprehensive Breast Center · Columbus, OH 43212Robert Wesolowski · Principal investigatorMore trials in Columbus

OR

  • Providence Cancer Institute Franz Clinic · Portland, OR 97213David Page · Principal investigatorMore trials in Portland

TN

  • The West Clinic, PLLC dba West Cancer Center · Germantown, TN 38138Gregory Vidal · Principal investigatorMore trials in Germantown
  • Sarah Cannon Research Institute · Nashville, TN 37203SMO Sarah Cannon Research Inst. · Principal investigatorMore trials in Nashville

TX

  • Mary Crowley Cancer Research Center · Dallas, TX 75230More trials in Dallas
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center · Dallas, TX 75246-2092Joyce O'Shaughnessy · Principal investigatorMore trials in Dallas
  • University of Texas Southwestern · Dallas, TX 75390Nisha Unni · Principal investigatorMore trials in Dallas
  • University of Texas MD Anderson Cancer Center · Houston, TX 77030Jordi Rodon Ahnert · Principal investigatorMore trials in Houston
  • START San Antonio · San Antonio, TX 78229Amita Patnaik · Principal investigatorMore trials in San Antonio

UT

VA

  • USO-Virginia Cancer Specialists, PC · Fairfax, VA 22031Alexander Spira · Principal investigatorMore trials in Fairfax