A Phase 1/2a Study of K-1728 in Advanced Solid Tumors (PIKYMA-01)

October 1, 2026 updated by: KymaThera, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: K-1728 Monotherapy

Participants receive K-1728 orally as monotherapy
Drug: K-1728

K-1728 will be administered orally once daily in 28-day cycles
Experimental: K-1728 + Endocrine Therapy

Participants receive K-1728 orally in combination with endocrine therapy
Drug: K-1728

K-1728 will be administered orally once daily in 28-day cycles

Drug: Fulvestrant

Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle
Experimental: K-1728 + Endocrine Therapy + CDK4/6 Inhibitor

Participants receive K-1728 orally in combination with endocrine therapy and a CDK4/6 inhibitor
Drug: K-1728

K-1728 will be administered orally once daily in 28-day cycles

Drug: Fulvestrant

Fulvestrant will be administered intramuscularly on Days 1 and 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle

Drug: Palbociclib

Palbociclib will be administered orally on Days 1-21 in 28-day cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)
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
Initiation of study drug through Cycle 1 (28 days)
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
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
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
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
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
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
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)
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
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
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

Cmax of K-1728 when administered as monotherapy or in combination
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

Tmax of K-1728 when administered as monotherapy or in combination
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

AUC of K-1728 when administered as monotherapy or in combination
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

t1/2 of K-1728 when administered as monotherapy or in combination
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

Objective Response Rate (ORR) as assessed by RECIST v1.1
Initiation of study drug until disease progression, assessed up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KymaThera, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K-1728-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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