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A Phase 1/2a Study of K-1728 in Advanced Solid Tumors

ConditionsBreast NeoplasmsSolid TumorsPIK3CA Gene Mutation
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKymaThera, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active or untreated central nervous system disease

Clinical significant or uncontrolled cardiovascular disease

Significant or uncontrolled intercurrent illness

Pregnant or breastfeeding

Trial design

Design model

Sequential

Treatments tested in this trial

  • K-1728

    Drug

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

  • Fulvestrant

    Drug

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

  • Palbociclib

    Drug

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

Treatment groups

110 Participants
are divided into 3 treatment groups
Group A: K-1728 MonotherapyExperimental treatment 1 intervention
Group B: K-1728 + Endocrine TherapyExperimental treatment 2 interventions
Group C: K-1728 + Endocrine Therapy + CDK4/6 InhibitorExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months)
2

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

Time frame
Initiation of study drug through Cycle 1 (28 days)
3

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

Time frame
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)
4

Changes in laboratory parameters

Compared to baseline, changes in laboratory parameters with K-1728 administered as monotherapy and in combination

Time frame
From first dose through 30 days after the last dose of study treatment (up to approximately 24 months)

Secondary outcomes

1

Pharmacokinetics - Maximum Plasma Concentration (Cmax) of K-1728

Cmax 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
2

Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) of K-1728

Tmax 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
3

Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC) of K-1728

AUC 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
4

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

Time frame
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle until end of treatment, approximately 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KymaThera, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: