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NCT05768139RECRUITINGIRB Ready

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

Sponsored by Eli Lilly and Company

Quick Self-Assessment

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0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Study STX-478-101 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.

Who Can Participate

Inclusion Criteria

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 PI3Kฮฑ mutation (cohort specific criterion for cohort-specific mutation types) 4. Is โ‰ฅ18 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 Key

Exclusion Criteria

Has history (within โ‰ค2 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 โ‰ฅ8% and/or FBG โ‰ฅ140 mg/dL \[7.7 mmol/L\] and/or requiring or required insulin). 4. Has had prior t

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

720 participants

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Gender

ALL

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Sponsor

Eli Lilly and Company

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
COMPLETED

New Haven

Connecticut

Location available
View New Haven location page
COMPLETED

Lake Mary

Florida

Location available
View Lake Mary location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
NOT_YET_RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
RECRUITING

New Orleans

Louisiana

Location available
View New Orleans location page

๐Ÿ“ And 21 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Advanced Solid Tumors Treatment in Los Angeles?

Join others in California exploring innovative treatment options through clinical research

Advanced Solid Tumors Treatment Options in Los Angeles, California

If you're searching for Advanced Solid Tumors treatment in Los Angeles, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Los Angeles, San Francisco, Aurora and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Advanced Solid Tumors. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 720 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Advanced Solid Tumors?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Advanced Solid Tumors

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Advanced Solid Tumors Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05768139. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.