Tersolisib for Advanced Solid Tumors

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

Recruiting Phase 1 Phase 2 Interventional Study
Breast Cancer Solid Tumors, Adult
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
880 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for adults with advanced solid tumors that are hard to treat. Participants will receive a treatment called Tersolisib either by itself or together with other cancer medications.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have an advanced solid tumor that's hard to treat.
  • I can provide a recent tumor biopsy or tissue sample.
  • My tumor has a specific genetic mutation called PI3Kα.
  • I am 18 years or older.
  • I have a good performance status scoring 0 or 1.
  • My organs are functioning well as per the study.
  • I have not received certain cancer treatments before.

You may not be able to join if

  • I have had a different type of cancer in the past 2 years.
  • I have active brain or spinal cancer spread.
  • I have uncontrolled diabetes.
  • I have previously taken certain cancer drugs called PI3K/AKT/mTOR inhibitors.
  • I have had cancer treatment within the last 14 days.
  • I have not fully recovered from past cancer treatment side effects.
  • I have had radiation therapy in the last 14 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial
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 th…
Trial Locations
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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…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT