Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

NCT07560410 | Not Yet Recruiting Phase 1

• 1 other identifier: CMUH115-REC2-048
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator-initiated, single-center clinical trial evaluating the efficacy and safety of ALK inhibitors in patients with locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations. Eligible patients must have disease progression after standard therapy or no suitable standard treatment options. Participants will receive either crizotinib (Xalkori®) or alectinib (Alecensa®), with treatment selection determined by the study investigators. The study aims to assess antitumor activity, safety, and clinical outcomes in this rare molecular subtype of bone cancer.

Conditions

ALK-positive Bone Cancer; Truncated ALK (ALKATI)-Positive Malignancy; Bone Cancer

Keywords

bone cancer; Truncated ALK (ALKATI)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate, defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

  Up to 24 weeks (or every 8-12 weeks per imaging assessment)

Study Arms (1)

ALK Inhibitor Treatment

EXPERIMENTAL

Alectinib: 450 mg/day, administered orally, three times daily (one capsule per dose).

Drug: Alectinib

Interventions

Alectinib DRUG

Patients will receive oral anaplastic lymphoma kinase (ALK) inhibitor therapy for locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations. Treatment will include alectinib. The dosing regimen of alectinib, including starting dose and any subsequent adjustments, will be determined by the investigators based on clinical response and tolerability. Each treatment cycle is defined as 4 weeks. Drug selection and dose modifications will be at the discretion of the investigators. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal from the study.

ALK Inhibitor Treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years. Patients with locally advanced or metastatic solid tumors harboring deficiency or alteration of anaplastic lymphoma kinase (ALK) tyrosine kinase.
• Disease progression during or within 6 months after completion of standard therapy, or no appropriate standard treatment available.
• At least one measurable lesion according to applicable response evaluation criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Estimated life expectancy of at least 8 weeks.

You may not qualify if:

• Known hypersensitivity to crizotinib or alectinib. Current or prior use of ALK inhibitors. Current use of tyrosine kinase inhibitors. Receipt of radiotherapy within 2 weeks prior to study entry. Palliative radiotherapy to non-target lesions is permitted.
• History of other malignancies, except for osteosarcoma or chondrosarcoma, unless the patient has been disease-free for at least 2 years. Exceptions include adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
• Liver cirrhosis with a Child-Pugh score ≥ 8. Uncorrectable electrolyte abnormalities. Presence of brain metastases. Active acute infection. Significant unresolved toxicity from prior therapy. Comorbid conditions that may interfere with study participation, including but not limited to uncontrolled diabetes mellitus, autoimmune diseases, or any condition that, in the investigator's judgment, renders the patient unsuitable for the study.
• Concurrent malignancy, unless it is adequately treated carcinoma in situ or basal cell carcinoma, or a malignancy that has been treated and has remained recurrence-free for at least 3 years.
• Pregnant or breastfeeding women. Patients with psychiatric disorders that may impair compliance with study requirements.
• Current use of strong inducers or inhibitors of CYP3A enzymes, or use of other investigational or non-approved drugs.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

alectinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Department of Orthopedics

  China Medical University Hospital

  STUDY DIRECTOR

Central Study Contacts

Yi-Chin Fong

CONTACT

+886-909-183-619; yichin.fong@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): April 14, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

TW (1)