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New drug targets Hard-to-Treat cancers with PIK3CA mutation

NCT ID NCT05216432

Disease control Sponsor: Relay Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage study is testing a new drug called RLY-2608, which is designed to block a specific mutant protein (PIK3CA) that helps some cancers grow. The trial includes people with advanced solid tumors or breast cancer that has not responded to other treatments. Participants will receive RLY-2608 alone or combined with other cancer drugs to find the safest dose and see if it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RLY-2608 (a targeted drug that blocks a specific mutant protein in cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have a specific genetic mutation (PIK3CA), potentially slowing cancer growth.
What could go wrong
This is an early Phase 1 trial, so the drug may not work as hoped or could cause serious side effects. It is also only for people with a specific mutation, so it won't apply to most cancer patients.
Why investors are watching

Relay Therapeutics is testing RLY-2608, a drug designed to target a specific genetic mutation (PIK3CA) found in some advanced solid tumors and breast cancers. This is the first human study of the drug, and for a small company, the safety and early effectiveness data from this trial will determine whether the drug has a future. A clear signal that the drug shrinks tumors or stabilizes disease would validate the company's core research approach.

If it works: A positive result could show that RLY-2608 works in patients with the PIK3CA mutation, which would support moving the drug into larger, later-stage trials. That progress could make Relay a more credible player in targeted cancer therapy and attract partnership interest.

If it fails: Phase 1 trials often fail because the drug proves too toxic or shows little benefit. If RLY-2608 disappoints, Relay would face a major setback, as this drug is a central part of its pipeline, and the company's value would likely drop.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 930 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria Patient has ECOG performance status of 0-1 One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment Other potentially oncogenic PIK3CA mutations may be considered but must be approved by the Sponsor prior to enrollment. Part 1 \[Escalation\] - Ability to provide archived tumor tissue or be willing to undergo pretreatment tumor biopsy to assess PIK3CA status retrospectively Part 2 \[Expansion\] - Submit tumor tissue prior to study drug initiation for determination of PIK3CA mutation retrospectively. Key Inclusion for RLY-2608 Single Agent Arm * \[For Part 1: Escalation\]: Evaluable disease per RECIST v1.1 * \[For Part 2: Expansion\]: Measurable disease per RECIST v1.1 * Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy. * Part 1- histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor * Part 2 - Unresectable or metastatic solid tumor with PIK3CA mutation(s) and one of the following tumor types: Group 1: clear cell ovarian cancer Group 2: head and neck squamous cell carcinoma Group 3: cervical cancer Group 4: other solid tumors, excluding colorectal, clear cell ovarian, head and neck squamous cell, and cervical cancers Group 5: unresectable or metastatic solid tumors with PIK3CA double mutations In addition, the SRC (with Sponsor approval) may choose to open additional group(s) of 20 participants to study the clinical activity, safety, and PK/PD with other specified solid tumor types. Key Inclusion for Combination Arms: * Doublet combination arms \[Part 1 and Part 2\]: Evaluable disease per RECIST v1.1 * Triplet combination arms: * \[Part 1 and Part 2 Dose Expansion, Group 1\]: Evaluable disease per RECIST. * \[Part 2 Dose Expansion, Group 2\]: Measurable disease per RECIST. Bone-only lytic or lytic/blastic disease with at least 1 measurable soft-tissue component per RECIST may be eligible. * \[For Part 1 and Part 2\]: Male or female with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy. Females may be postmenopausal, premenopausal, or perimenopausal. Premenopausal or perimenopausal females must have a histologically or cytologically confirmed diagnosis of HR+ HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy and must have initiated treatment with a gonadotropin-releasing hormone (GnRH) agonist at least 4 weeks prior to start of study drug with continuation of GnRH agonist for the duration of study treatment (GnRH agonist recommended for males). * Had previous treatment for breast cancer with: \[Does not apply to triplet combination arms, Part 2 Dose Expansion, Group 2\]: 1. ≤1 line of chemotherapy in the metastatic setting 2. ≥1 CDK4/6 inhibitor in either the adjuvant and/or metastatic setting 3. ≥1 antiestrogen therapy in either adjuvant and/or metastatic setting, including, but not limited to, selective estrogen-receptor degraders (eg, fulvestrant), selective estrogen receptor modulators (eg, tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane), and 4. ≥1 PARP inhibitor, if appropriate, if documented germline BRCA1/2 mutation Note: Systemic local, loco-regional, or adjuvant treatment with chemotherapy and PARP inhibitors is not to be included in enumeration or previous treatment \[For double combination arm; Part 2 Dose Expansion, Group 2\]: Received prior treatment with a PI3Kα, AKT, or mTOR inhibitor and discontinued the inhibitor due to intolerance and not disease progression, where intolerance is defined as treatment discontinuation due to treatment related AE (eg. hyperglycemia, rash, diarrhea, stomatitis) other than severe hypersensitivity reaction and/or life-threatening reactions, such as anaphylaxis and Stevens-Johnson syndrome. \[For triple combination arms; Part 1 dose escalation\]: Participants who had previous treatment for breast cancer with PI3Kα, AKT, mTOR inhibitors and discontiuned due to participant/physician decision, intolerance, or disease progression will be considered. \[For triple combination arms, Part 2 Dose Expansion, Group 2\]: Participants must be intolerant to or have declined standard therapy for locally advanced or metastatic HR+/HER2- PIK3CA-mutated breast cancer. Prior endocrine therapy and CDK4/6inhibitors are allowed as follows: 1. Participants must have progressed during (neo)adjuvant endocrine therapy or within12 months of completing (neo)adjuvant endocrine therapy with an AI or tamoxifen. 2. If a CDK4/6 inhibitor was included as part of (neo)adjuvant therapy, disease must have recurred/progressed \>12 months after completion of the CDK4/6 inhibitor portion of (neo)adjuvant therapy Key Exclusion Criteria Prior treatment with: 1. PI3Kα, AKT, or mTOR inhibitors (all arms except for doublet RLY-2608 + fulvestrant arm, Part 2, Group 2; and triplet combinations, Part 1 dose escalation). 2. Immune checkpoint inhibitors. 3. Triplet combinations RLY-2608 + CDK4 or CDK4/6 inhibitor + fulvestrant, Part 2 expansion, Group 2 only: i. Prior systemic chemotherapy or antibody drug conjugate for locally advanced or metastatic disease. ii. Prior CDK2, CDK4, or CDK4/6 inhibitor as treatment for locally advanced or metastatic disease. iii. Prior treatment with fulvestrant or any selective ER degrader, with the exception of patients who have received fulvestrant or any selective ER degrader as part of neoadjuvant therapy only and with treatment duration ≤6 months. Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%. History of allergy or hypersensitivity to any components or excipients of PI3K inhibitors. For combination arms only: allergy or hypersensitivity to any components or excipients of fulvestrant, palbociclib, ribociclib, and/or PF-07220060 as appropriate for the combination. Past medical history of or ongoing ILD, or pneumonitis requiring intervention. Participants with past history of resolved Grade 1 pneumonitis may be considered, except in triple combination arms. The following cardiac criteria: * Mean resting corrected QT interval (QTc) \>460 msec * For triple combination arm with ribociclib: Mean QTcF ≥450 msec (this is what we confirmed is shown in the redacted version of the protocol. CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm Her2-receptor negative breast cancer hormone receptor-positive breast cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Breast cancer HER2-negative breast cancer Metastatic breast cancer PIK3CA mutation Solid tumor, adult Unresectable solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    36 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Boca Raton Clinical Research (BRCR) Global

    WITHDRAWN

    Plantation, Florida, 33322, United States

  • Centre Léon Bérard

    RECRUITING

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Columbia University Herbert Irving Comprehensive Cancer Center

    RECRUITING

    New York, New York, 10032, United States

  • Community Health Network

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    RECRUITING

    Orlando, Florida, 32827, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Inova Schar Cancer Center

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Institut Catala D'Oncologia - Badalona (ICO Badalona)

    RECRUITING

    Barcelona, 08916, Spain

  • Institute Bergonié

    RECRUITING

    Bordeaux, 33076, France

  • Instituto Valenciano de Oncologia

    RECRUITING

    Valencia, Valencia, 46009, Spain

  • Istituto Europeo di Oncologia IRCCS

    RECRUITING

    Milan, 20141, Italy

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22301, United States

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • Peter MacCallum Cancer Center

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • Rutgers University

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • START Barcelona

    RECRUITING

    Barcelona, Catalonia, 08023, Spain

  • START Madrid - Hospital Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • St Vincents Hospital

    RECRUITING

    Sydney, New South Wales, 2019, Australia

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85724, United States

  • The University of Texas M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UW Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • University of California-San Diego

    RECRUITING

    San Diego, California, 90293, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Utah- Huntsman Cancer Center

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Vall d'Hebron Instituto de Oncologia

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Washington University School of Medicine St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

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