PIK3CA MutationPhase 1NCT05759949
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
A Phase 1 study testing RLY-5836, Fulvestrant and Palbociclib in people with PIK3CA Mutation and Solid Tumor, Adult, run by Relay Therapeutics, Inc. at 7 sites in United States.
Trial summary
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in… 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-5836, Fulvestrant and Palbociclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Mar 2023to 11 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- RLY-5836 single agent arm key inclusion criteria
- Disease that is refractory to standard therapy, intolerant to standard therapy, or participant has declined standard therapy.
- A histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
- Combination arms key inclusion criteria
Show all 9Show fewer
- Males, postmenopausal females, or pre-/perimenopausal females previously treated with gonadotropin-releasing GnRH agonist at least 4 weeks prior to start of study drug with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy.
- Had previous treatment for advanced or metastatic breast cancer with antiestrogen therapy including, but not limited to, selective estrogen receptor degraders (e.g., fulvestrant), selective estrogen receptor modulators (e.g., tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane)
- Part 1: Prior PI3Kα inhibitor treatment is allowed if taken for < 14 days and not discontinued due to disease progression, hypersensitivity, or ≥ Grade 3 TEAEs.
Who cannot join
- Part 2: Prior treatment with PI3Kα inhibitors.
- Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Community Cancer Center North
Indianapolis, Indiana, 46250
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Memorial Sloan Kettering Cancer Center-Main Campus
New York, New York, 10065
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A First-in-Human Study of PI3Kα Inhibitor, RLY-5836, in Combination With Targeted and Endocrine Therapies in Participants With Advanced Breast Cancer and as a Single Agent in Advanced Solid Tumors
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 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-5836, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib
- 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-5836Drug
RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
FulvestrantDrug
Also called Faslodex
Fulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle.
PalbociclibDrug
Also called Ibrance
Palbociclib 125 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
RibociclibDrug
Also called Kisqali
Ribociclib 600 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
AbemaciclibDrug
Also called Verzenio
Abemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| RLY-5836 Single Agent Arm | Experimental | RLY-5836 single agent arm for participants with unresectable or metastatic solid tumors Receives: Drug: RLY-5836 |
| RLY-5836 + Fulvestrant Arm | Experimental | RLY-5836 + fulvestrant combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer Receives: Drug: RLY-5836; Drug: Fulvestrant |
| RLY-5836 + Palbociclib + Fulvestrant Arm | Experimental | RLY-5836 + palbociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer Receives: Drug: RLY-5836; Drug: Fulvestrant; Drug: Palbociclib |
| RLY-5836 + Ribociclib + Fulvestrant Arm | Experimental | RLY-5836 + ribociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer Receives: Drug: RLY-5836; Drug: Fulvestrant; Drug: Ribociclib |
| RLY-5836 + Abemaciclib + Fulvestrant Arm | Experimental | RLY-5836 + abemaciclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer Receives: Drug: RLY-5836; Drug: Fulvestrant; Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-5836
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 participants with any dose-limiting toxicity (DLT)
Measured: Cycle 1, up to 28 days.
Number of participants with adverse events (AEs)
Measured: Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Number of participants with serious adverse events (SAEs)
Measured: Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Secondary outcomes (13)
PIK3CA genotype in blood and tumor tissue by next generation nucleic acid sequencing
Measured: Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months
PK of RLY-5836: area under the concentration-time curve (AUC)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: maximum plasma concentration (Cmax)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: time to maximum concentration (tmax)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: half-life (t½)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: clearance following oral dose (CL/F)
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
Changes in circulating markers of glucose metabolism: changes in circulating glucose
Measured: Approximately every week in Cycle 1 (4-week cycle), every 2 weeks in Cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months
Changes in circulating markers of glucose metabolism: changes in circulating insulin
Measured: Approximately every week in Cycle 1 (4-week cycle), every 2 weeks in Cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months
Changes in circulating markers of glucose metabolism: changes in circulating C-peptide
Measured: Approximately every week in Cycle 1 (4-week cycle), every 2 weeks in Cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months
Changes in circulating markers of glucose metabolism: changes in circulating glycosylated hemoglobin [HbA1c]
Measured: Approximately every week in Cycle 1 (4-week cycle), every 2 weeks in Cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months
Preliminary antitumor activity of RLY-5836: duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Measured: Approximately every 8 weeks until progressive disease, approximately 36 months
Preliminary antitumor activity of RLY-5836: disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Measured: Approximately every 8 weeks until progressive disease, approximately 36 months
Preliminary antitumor activity of RLY-5836: objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Measured: Approximately every 8 weeks until 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 posted8 Mar 2023
- Study start29 Mar 2023
- Primary completion18 Mar 2025
- Study completion11 Apr 2025
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
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relay Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759949
- Sponsor's protocol ID
- RLY-5836-101
- Status last verified
- May 2025
- First submitted
- 23 Jan 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of PI3Kα Inhibitor, RLY-5836, in Combination With Targeted and Endocrine Therapies in Participants With Advanced Breast Cancer and as a Single Agent in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05759949
- Acronym / sponsor ID
- RLY-5836-101
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Relay Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RLY-5836 Single Agent Arm | Experimental | Drug: RLY-5836RLY-5836 single agent arm for participants with unresectable or metastatic solid tumors |
| RLY-5836 + Fulvestrant Arm | Experimental | Drug: RLY-5836, Drug: FulvestrantRLY-5836 + fulvestrant combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer |
| RLY-5836 + Palbociclib + Fulvestrant Arm | Experimental | Drug: RLY-5836, Drug: Fulvestrant, Drug: PalbociclibRLY-5836 + palbociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer |
| RLY-5836 + Ribociclib + Fulvestrant Arm | Experimental | Drug: RLY-5836, Drug: Fulvestrant, Drug: RibociclibRLY-5836 + ribociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer |
| RLY-5836 + Abemaciclib + Fulvestrant Arm | Experimental | Drug: RLY-5836, Drug: Fulvestrant, Drug: AbemaciclibRLY-5836 + abemaciclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- RLY-5836 single agent arm key inclusion criteria
- Disease that is refractory to standard therapy, intolerant to standard therapy, or participant has declined standard therapy.
- A histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
Key exclusion criteria (2 listed)
- Part 2: Prior treatment with PI3Kα inhibitors.
- Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLY-5836RLY-5836 is a mutant-selective, oral PI3Kα inhibitor. | Drug | RLY-5836 + Abemaciclib + Fulvestrant Arm, RLY-5836 + Fulvestrant Arm, RLY-5836 + Palbociclib + Fulvestrant Arm, RLY-5836 + Ribociclib + Fulvestrant Arm, RLY-5836 Single Agent Arm |
| FulvestrantAlso: FaslodexFulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle. | Drug | RLY-5836 + Abemaciclib + Fulvestrant Arm, RLY-5836 + Fulvestrant Arm, RLY-5836 + Palbociclib + Fulvestrant Arm, RLY-5836 + Ribociclib + Fulvestrant Arm |
| PalbociclibAlso: IbrancePalbociclib 125 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. | Drug | RLY-5836 + Palbociclib + Fulvestrant Arm |
| RibociclibAlso: KisqaliRibociclib 600 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. | Drug | RLY-5836 + Ribociclib + Fulvestrant Arm |
| AbemaciclibAlso: VerzenioAbemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles. | Drug | RLY-5836 + Abemaciclib + Fulvestrant Arm |
Primary outcome
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-5836
Time frame: 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 participants with any dose-limiting toxicity (DLT)
Time frame: Cycle 1, up to 28 days.
Number of participants with adverse events (AEs)
Time frame: Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Number of participants with serious adverse events (SAEs)
Time frame: Every cycle (4-week cycles) until study discontinuation, approximately 24 months
13 secondary outcomes
PIK3CA genotype in blood and tumor tissue by next generation nucleic acid sequencing
Time frame: Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months
PK of RLY-5836: area under the concentration-time curve (AUC)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: maximum plasma concentration (Cmax)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: time to maximum concentration (tmax)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: half-life (t½)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: clearance following oral dose (CL/F)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
Changes in circulating markers of glucose metabolism: changes in circulating glucose
Time frame: Approximately every week in Cycle 1 (4-week cycle), every 2 weeks in Cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months
Changes in circulating markers of glucose metabolism: changes in circulating insulin
Time frame: Approximately every week in Cycle 1 (4-week cycle), every 2 weeks in Cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months
Changes in circulating markers of glucose metabolism: changes in circulating C-peptide
Time frame: Approximately every week in Cycle 1 (4-week cycle), every 2 weeks in Cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months
Changes in circulating markers of glucose metabolism: changes in circulating glycosylated hemoglobin [HbA1c]
Time frame: Approximately every week in Cycle 1 (4-week cycle), every 2 weeks in Cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months
Preliminary antitumor activity of RLY-5836: duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Time frame: Approximately every 8 weeks until progressive disease, approximately 36 months
Preliminary antitumor activity of RLY-5836: disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Time frame: Approximately every 8 weeks until progressive disease, approximately 36 months
Preliminary antitumor activity of RLY-5836: objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Time frame: Approximately every 8 weeks until progressive disease, approximately 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RLY-5836, Fulvestrant and Palbociclib in people with PIK3CA Mutation and Solid Tumor, Adult, run by Relay Therapeutics, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-5836 (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.