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A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors

NCT07787520 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-26

No results posted yet for this study

Summary

Study Title:

A Phase I, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LAE118 as Monotherapy and in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors

Study Design Overview:

This is an open-label, multicenter Phase I clinical trial comprising three cohorts: Cohort A (LAE118 monotherapy), Cohort B (LAE118 plus fulvestrant), and Cohort C (LAE118 plus fulvestrant and palbociclib). Each cohort consists of two stages. Stage I evaluates safety and determines the maximum tolerated dose (MTD) and recommended dose (RD) of LAE118; Stage II assesses the preliminary efficacy of LAE118 at the RD.

Conditions

  • Patients With Advanced Solid Tumors

Interventions

DRUG

LAE118

LAЕ118 is a novel, allosteric and highly potent selective inhibitor of PIK3CA. Its activity against PIK3CA mutant cells is superior to that of other broad-spectrum selective inhibitors.

DRUG

Fulvestrant

Fulvestrant is approved for the treatment of post-menopausal metastatic breast cancer following disease progression on therapy with an anti-estrogen therapy.

DRUG

Palbociclib

Palbociclib is a CDK4/6 inhibitor. Multiple clinical studies have shown that palbociclib combined with endocrine therapy has demonstrated significant clinical benefits in study participants with HR+/HER2- advanced breast cancer.

Sponsors & Collaborators

  • Laekna Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-03-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787520 on ClinicalTrials.gov