PIK3CA MutationPhase 1NCT05216432
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
A Phase 1 study testing RLY-2608, Fulvestrant and Palbociclib 125mg in people with PIK3CA Mutation and Solid Tumor, Adult, run by Relay Therapeutics, Inc. at 37 sites in 5 countries.
Trial summary
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer
- What is being tested?
- RLY-2608, Fulvestrant and Palbociclib 125mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 930 participants
- Where
- 37 sitesin 5 countries
- Study dates
- 8 Dec 2021to 30 Apr 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- [For Part 1: Escalation]: Evaluable disease per RECIST v1.1
- [For Part 2: Expansion]: Measurable disease per RECIST v1.1
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- 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.
- 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 line of chemotherapy in the metastatic setting
- ≥1 CDK4/6 inhibitor in either the adjuvant and/or metastatic setting
- ≥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
- ≥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:
- Participants must have progressed during (neo)adjuvant endocrine therapy or within12 months of completing (neo)adjuvant endocrine therapy with an AI or tamoxifen.
- 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
Who cannot join
- Prior treatment with:
- 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).
- Immune checkpoint inhibitors.
- Triplet combinations RLY-2608 + CDK4 or CDK4/6 inhibitor + fulvestrant, Part 2 expansion, Group 2 only:
- 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.
- 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.
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- 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
Trial locations and contacts
37 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 5 countries
United States24 sites, 23 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
- Recruiting
HealthONE
Denver, Colorado, 80218
- Recruiting
Inova Schar Cancer Center
Fairfax, Virginia, 22031
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22301
- Recruiting
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Community Health Network
Indianapolis, Indiana, 46250
- Recruiting
UW Carbone Cancer Center
Madison, Wisconsin, 53792
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
Rutgers University
New Brunswick, New Jersey, 08901
- Recruiting
Yale University
New Haven, Connecticut, 06510
- Recruiting
NYU Langone
New York, New York, 10016
- Recruiting
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
- Recruiting
Memorial Sloan Kettering
New York, New York, 10065
- Recruiting
Florida Cancer Specialists
Orlando, Florida, 32827
- Withdrawn
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, 33322
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
University of Utah- Huntsman Cancer Center
Salt Lake City, Utah, 84112
- Recruiting
University of California-San Diego
San Diego, California, 90293
- Recruiting
Washington University School of Medicine St. Louis
St Louis, Missouri, 63110
- Recruiting
The University of Arizona Cancer Center
Tucson, Arizona, 85724
Spain6 sites, 6 recruiting
- Recruiting
Vall d'Hebron Instituto de Oncologia
Barcelona, Barcelona, 08035
- Recruiting
START Barcelona
Barcelona, Catalonia, 08023
- Recruiting
Institut Catala D'Oncologia - Badalona (ICO Badalona)
Barcelona, 08916
- Recruiting
START Madrid - Hospital Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Instituto Valenciano de Oncologia
Valencia, Valencia, 46009
Australia3 sites, 3 recruiting
- Recruiting
Peter MacCallum Cancer Center
Melbourne, Victoria, 3000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
St Vincents Hospital
Sydney, New South Wales, 2019
France3 sites, 3 recruiting
- Recruiting
Institute Bergonié
Bordeaux, 33076
- Recruiting
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, 69008
- Recruiting
Gustave Roussy
Villejuif, 94805
Italy1 site, 1 recruiting
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
About this study
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors. It will also evaluate RLY-2608 in combination RLY-2608 + fulvestrant and in triple combination RLY-2608 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) or CDK4 inhibitor (PF-07220060) for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2).
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
- Being tested
- RLY-2608, Fulvestrant, Palbociclib 125mg, Ribociclib 400mg, Ribociclib 600mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLY-2608Drug
RLY-2608 is a mutant-selective, oral PI3Kα inhibitor.
FulvestrantDrug
Also called Faslodex
500 mg fulvestrant is administered intramuscularly on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (where a cycle is 28 days).
Palbociclib 125mgDrug
Also called Ibrance
125mg palbociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
Ribociclib 400mgDrug
Also called Kisqali
400mg ribociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
Ribociclib 600mgDrug
Also called Kisqali
600mg ribociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
PF-07220060 100mgDrug
PF-07220060 100 mg is taken orally twice daily at the same time with RLY-2608 during each 28-day cycle.
PF-07220060 300 mgDrug
PF-07220060 300 mg is taken orally twice daily at the same time with RLY-2608 during each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| RLY-2608 for patients with unresectable or metastatic solid tumors | Experimental | Multiple doses of RLY-2608 for oral administration. Receives: Drug: RLY-2608 |
| RLY-2608 + fulvestrant combination for HR+ HER2- locally advanced or metastatic breast cancer | Experimental | Oral dose of RLY-2608 in addition to fulvestrant as determined during Part 1 Dose Escalation. Receives: Drug: RLY-2608; Drug: Fulvestrant |
| RLY-2608+fulvestrant+palbo125mg for HR+HER2- locally advanced metastatic breast cancer | Experimental | Oral dose of RLY-2608 in addition to fulvestrant and palbociclib 125mg as determined during Part 1 Dose Escalation. Receives: Drug: RLY-2608; Drug: Fulvestrant; Drug: Palbociclib 125mg |
| RLY-2608+fulvestrant+ribo400mg for HR+HER2- locally advanced metastatic breast cancer | Experimental | Oral dose of RLY-2608 in addition to fulvestrant and ribociclib 400mg as determined during Part 1 Dose Escalation. Receives: Drug: RLY-2608; Drug: Fulvestrant; Drug: Ribociclib 400mg |
| RLY-2608+fulvestrant+ribo600mg for HR+HER2- locally advanced metastatic breast cancer | Experimental | Oral dose of RLY-2608 in addition to fulvestrant and ribociclib 600mg as determined during Part 1 Dose Escalation. Receives: Drug: RLY-2608; Drug: Fulvestrant; Drug: Ribociclib 600mg |
| RLY-2608+fulvestrant+PF-07220060 100 mg for HR+ HER2- locally advanced or metastatic breast cancer | Experimental | Oral dose of RLY-2608 in addition to fulvestrant and PF-07220060 100 mg as determined during Part 1 Dose Escalation Receives: Drug: RLY-2608; Drug: Fulvestrant; Drug: PF-07220060 100mg |
| RLY-2608+fulvestrant+PF-07220060 300 mg for HR+ HER2- locally advanced or metastatic breast cancer | Experimental | Oral dose of RLY-2608 in addition to fulvestrant and PF-07220060 300 mg as determined during Part 1 Dose Escalation Receives: Drug: RLY-2608; Drug: Fulvestrant; Drug: PF-07220060 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 as a single agent
Measured: Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months
Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant
Measured: Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months
Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant and a CDK 4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant
Measured: Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months
Number of patients with adverse events and serious adverse events of RLY-2608 as a single agent
Measured: Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Number of patients with adverse events and serious adverse events of RLY-2608 in combination with fulvestrant
Measured: Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Number of patients with adverse events and serious adverse events of RLY-2608 in combination with fulvestrant and a CDK 4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant
Measured: Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Secondary outcomes (26)
PIK3CA gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue
Measured: Day 1 of Cycle 1 (each cycle is 28 days)
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax) of RLY-2608 (and its metabolites, as appropriate) as single agent
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
Pharmacokinetic parameters including area under the plasma concentration versus time curve during a dose interval (AUC0-tau) of RLY-2608 (and its metabolites, as appropriate) as single agent
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
Pharmacokinetic parameters including half-life (t1/2) of RLY-2608 (and its metabolites, as appropriate) as single agent
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
Pharmacokinetic parameters including area under the plasma concentration versus time curve during a dose interval (AUC0-tau) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
Pharmacokinetic parameters including half-life (t1/2) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
PK parameters including maximum plasma drug concentration (Cmax) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant + palbociclib or ribociclib, and in combination (PF-07220060) +fulvestrant
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
PK parameters including area under the plasma concentration vs time curve during a dose interval (AUC0-tau) of RLY-2608 (and its metabolites, as appropriate) administered with fulvestrant + palbociclib, or ribociclib, or PF-07220060
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
Pharmacokinetic parameters including half-life (t1/2) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant + palbociclib or ribociclib, and in combination with PF-07220060 +fulvestrant
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment, approximately 24 months
Changes in circulating blood of fasting glucose in RLY-2608 as a single agent
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of insulin in RLY-2608 as a single agent
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of C-peptide in RLY-2608 as a single agent
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of HbA1c in RLY-2608 as a single agent
Measured: Once in Cycle 2 (4-week cycle) and then once every 3rd cycle beginning with Cycle 5 through end of treatment, approximately 24 months
Changes in circulating blood of fasting glucose in RLY-2608 in combination with fulvestrant
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of insulin in RLY-2608 in combination with fulvestrant
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of C-peptide in RLY-2608 in combination with fulvestrant
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of HbA1c in RLY-2608 in combination with fulvestrant
Measured: Once in Cycle 2 (4-week cycle) and then once every 3rd cycle beginning with Cycle 5 through end of treatment, approximately 24 months
Changes in circulating blood of fasting glucose in RLY-2608 in combination with fulvestrant and a CDK4/6 inhibitor (palbociclib, ribociclib) and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of insulin in RLY-2608 in combination with fulvestrant and a CDK4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of C-peptide in RLY-2608 in combination with fulvestrant and a CDK4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant
Measured: Approximately every week in Cycle 1 (4-week cycle), every two weeks in Cycle 2 (4-week cycle), and every cycle starting with Cycle 3 through end of treatment, approx 24 months
Changes in circulating blood of HbA1c in RLY-2608 in combination with fulvestrant and a CDK4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant
Measured: Once in Cycle 2 (4-week cycle) and then once every 3rd cycle beginning with Cycle 5 through end of treatment, approximately 24 months
Objective response rate (ORR) as assessed by RECIST v1.1
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Duration of Response (DOR) as assessed by RECIST v1.1
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Disease Control Rate (DCR) as assessed by RECIST v1.1
Measured: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Clinical benefit rate (CBR) as assessed by RECIST v1.1
Measured: [Time Frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start8 Dec 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PIK3CA MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single Agent Arm: Part 1(multiple ascending doses, QD or BID):unresectable or metastatic solid tumors with PIK3CA mutation per local assessment; Part 2 (RP2D determined in Part 1) Patients with unresectable or metastatic solid tumors with ≥1 PIK3CA mutation per local assessment will be enrolled protocol defined groups Double Combination Arm Part 1(multiple ascending doses, QD or BID): HR+, HER2- locally advanced or metastatic breast cancer with PIK3CA mutation per local assessment Part 2 (RP2D determined in Part 1) Group 1: patients who have not received prior PI3Kα inhibitor Group 2: patients who are intolerant to PI3Kα inhibitor Triple Combination Arms Part 1(multiple ascending doses, QD or BID): HR+, HER2- locally advanced or metastatic breast cancer with PIK3CA mutation per local assessment Part 2 (RP2D determined in Part 1) Patients with HR+, HER2-locally advanced or metastatic breast cancer with PIK3CA mutation per local assessment will be enrolled in protocol defined groups
- Masking
- None (open label)
- Enrolment
- 930 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Relay Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216432
- Sponsor's protocol ID
- RLY-2608-101
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No