RecruitingPhase 1/2

Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

China70 participantsStarted 2022-12-27

Plain-language summary

A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
✓. Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;
✓. At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
✓. Organ functions meet the clinical criteria

Exclusion criteria

✕. Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
✕. Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
✕. Patient with recent anti-tumor and other treatment as stated in the protocol.
✕. Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
✕. Other conditions considered unsuitable for participation in this trial at the discretion of the investigator

What they're measuring

Objective response rate (ORR)

Timeframe: Through study completion, an average of 4 years

Trial details

NCT IDNCT05745623

SponsorBeijing InnoCare Pharma Tech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-25

Contact for this trial

Ruihua Xu

020-87343333 xurh@sysucc.org.cn

View on ClinicalTrials.gov More Advanced Solid Tumors Harboring NTRK Fusion trials