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IN10018 in Combination With Dalpiciclib for Progressive Meningiomas

NCT07652762 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-07

No results posted yet for this study

Summary

This open-label Phase Ib study will evaluate the safety, tolerability, and preliminary effectiveness of IN10018 in combination with dalpiciclib in adults with progressive meningiomas. Progressive meningiomas are tumors arising from the membranes surrounding the brain that have continued to grow or have returned after previous treatment.

Participants will receive both study drugs by mouth in 28-day treatment cycles. IN10018 will be taken once daily throughout each cycle, and dalpiciclib will be taken once daily for 21 days followed by 7 days without dalpiciclib. Treatment may continue until the tumor progresses, unacceptable side effects occur, or another reason for stopping treatment applies.

The study includes a dose-confirmation phase and a dose-expansion phase. The main goals are to evaluate side effects and determine a recommended dose of the combination for further study. Researchers will also assess whether the treatment can shrink tumors or delay tumor growth, measure how the drugs are processed in the body, and explore tumor and blood biomarkers that may be associated with treatment response.

Conditions

Interventions

DRUG

Ifebemtinib

Ifebemtinib (IN10018) is an investigational oral focal adhesion kinase inhibitor. It will be administered once daily continuously during each 28-day treatment cycle. The starting dose is 100 mg once daily. If the starting dose is not tolerated, the dose may be reduced to 50 mg once daily. Ifebemtinib will be administered in combination with dalpiciclib until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion.

DRUG

Dalpiciclib

Dalpiciclib is an oral, selective cyclin-dependent kinase 4 and 6 inhibitor. It will be administered at a starting dose of 125 mg once daily on Days 1 through 21 of each 28-day treatment cycle, followed by 7 days without dalpiciclib. If the starting dose is not tolerated, the dose may be reduced to 100 mg once daily. Dalpiciclib will be administered in combination with ifebemtinib until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion.

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Hongwei Zhang, MD, PhD · Beijing Sanbo Brain Hospital, Capital Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2029-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07652762 on ClinicalTrials.gov