Breast NeoplasmsPhase 1/2PIKYMA-01NCT07861932
A Phase 1/2a Study of K-1728 in Advanced Solid Tumors
A Phase 1/2 study testing K-1728, Fulvestrant and Palbociclib in people with Breast Neoplasms and Solid Tumors, run by KymaThera, Inc..
Trial summary
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors. The study assesses the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of K-1728. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
- What is being tested?
- K-1728, 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
- 110 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Adults with advanced or metastatic solid tumors who are able to provide consent
- Documented activating PIK3CA mutation
- ECOG performance status 0 or 1
- Adequate organ function
Who cannot join
- Active or untreated central nervous system disease
- Clinical significant or uncontrolled cardiovascular disease
- Significant or uncontrolled intercurrent illness
- Pregnant or breastfeeding
- Other protocol-defined exclusion criteria
About this study
Official title: A First-in-Human Study of K-1728 Administered Alone and in Combination in Participants With Advanced or Metastatic Solid Tumors
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors. The study assesses the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of K-1728.
- Conditions
- Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
- Being tested
- K-1728, Fulvestrant, Palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-1728Drug
K-1728 will be administered orally once daily in 28-day cycles
FulvestrantDrug
Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle
PalbociclibDrug
Palbociclib will be administered orally on Days 1-21 in 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| K-1728 Monotherapy | Experimental | Participants receive K-1728 orally as monotherapy Receives: Drug: K-1728 |
| K-1728 + Endocrine Therapy | Experimental | Participants receive K-1728 orally in combination with endocrine therapy Receives: Drug: K-1728; Drug: Fulvestrant |
| K-1728 + Endocrine Therapy + CDK4/6 Inhibitor | Experimental | Participants receive K-1728 orally in combination with endocrine therapy and a CDK4/6 inhibitor Receives: Drug: K-1728; Drug: Fulvestrant; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)
Determination of the MTD/MED and RP2D of K-1728 administered as monotherapy and in combination
Measured: Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)
Incidence of Dose-Limiting Toxicities (DLTs)
Number and percentage of participants experiencing a dose-limiting toxicity during the DLT-evaluation period with of K-1728 administered as monotherapy and in combination
Measured: Initiation of study drug through Cycle 1 (28 days)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and percentage of participants with adverse events and serious adverse events with K-1728 administered as a monotherapy and in combination
Measured: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Changes in laboratory parameters
Compared to baseline, changes in laboratory parameters with K-1728 administered as monotherapy and in combination
Measured: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Changes in vital signs
Compared to baseline, changes in vital signs with K-1728 administered as monotherapy and in combination
Measured: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Changes in electrocardiogram (ECG) parameters
Compared to baseline, changes in ECG parameters (including QT interval, QTc interval, QRS complex, and PR interval)
Measured: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Changes in physical examination
Compared to baseline, changes in physical examination
Measured: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Secondary outcomes (5)
Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728
Cmax of K-1728 when administered as monotherapy or in combination
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) of K-1728
Tmax of K-1728 when administered as monotherapy or in combination
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC) of K-1728
AUC of K-1728 when administered as monotherapy or in combination
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Half-life (t1/2) of K-1728 when administered as monotherapy or in combination
t1/2 of K-1728 when administered as monotherapy or in combination
Measured: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Preliminary Efficacy - Overall Response Rate (ORR)
Objective Response Rate (ORR) as assessed by RECIST v1.1
Measured: Initiation of study drug until disease progression, assessed up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KymaThera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861932
- Sponsor's protocol ID
- K-1728-1001
- Acronym
- PIKYMA-01
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of K-1728 Administered Alone and in Combination in Participants With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07861932
- Acronym / sponsor ID
- PIKYMA-01 / K-1728-1001
- Conditions
- Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- KymaThera, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 6 Oct 2026 (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 first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors. The study assesses the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of K-1728.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| K-1728 Monotherapy | Experimental | Drug: K-1728Participants receive K-1728 orally as monotherapy |
| K-1728 + Endocrine Therapy | Experimental | Drug: K-1728, Drug: FulvestrantParticipants receive K-1728 orally in combination with endocrine therapy |
| K-1728 + Endocrine Therapy + CDK4/6 Inhibitor | Experimental | Drug: K-1728, Drug: Fulvestrant, Drug: PalbociclibParticipants receive K-1728 orally in combination with endocrine therapy and a CDK4/6 inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with advanced or metastatic solid tumors who are able to provide consent
- Documented activating PIK3CA mutation
- ECOG performance status 0 or 1
- Adequate organ function
Key exclusion criteria (5 listed)
- Active or untreated central nervous system disease
- Clinical significant or uncontrolled cardiovascular disease
- Significant or uncontrolled intercurrent illness
- Pregnant or breastfeeding
- Other protocol-defined exclusion criteria
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 |
|---|---|---|
| K-1728K-1728 will be administered orally once daily in 28-day cycles | Drug | K-1728 + Endocrine Therapy, K-1728 + Endocrine Therapy + CDK4/6 Inhibitor, K-1728 Monotherapy |
| FulvestrantFulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle | Drug | K-1728 + Endocrine Therapy, K-1728 + Endocrine Therapy + CDK4/6 Inhibitor |
| PalbociclibPalbociclib will be administered orally on Days 1-21 in 28-day cycles | Drug | K-1728 + Endocrine Therapy + CDK4/6 Inhibitor |
Primary outcome
Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D)
Time frame: Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)
Determination of the MTD/MED and RP2D of K-1728 administered as monotherapy and in combination
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Initiation of study drug through Cycle 1 (28 days)
Number and percentage of participants experiencing a dose-limiting toxicity during the DLT-evaluation period with of K-1728 administered as monotherapy and in combination
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Number and percentage of participants with adverse events and serious adverse events with K-1728 administered as a monotherapy and in combination
Changes in laboratory parameters
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Compared to baseline, changes in laboratory parameters with K-1728 administered as monotherapy and in combination
Changes in vital signs
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Compared to baseline, changes in vital signs with K-1728 administered as monotherapy and in combination
Changes in electrocardiogram (ECG) parameters
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Compared to baseline, changes in ECG parameters (including QT interval, QTc interval, QRS complex, and PR interval)
Changes in physical examination
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
Compared to baseline, changes in physical examination
5 secondary outcomes
Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) of K-1728
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC) of K-1728
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Pharmacokinetics - Half-life (t1/2) of K-1728 when administered as monotherapy or in combination
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months
Preliminary Efficacy - Overall Response Rate (ORR)
Time frame: Initiation of study drug until disease progression, assessed up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing K-1728, Fulvestrant and Palbociclib in people with Breast Neoplasms and Solid Tumors, run by KymaThera, Inc..
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D) (time frame: Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)). The study lists 7 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 6 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.