Actively Recruiting
A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations
Led by Sun Yat-sen University · Updated on 2025-06-04
71
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to evaluate the safety and tolerability of almonertinib combined with palbociclib in patients with advanced solid tumors harboring KRAS gene mutations, and to conduct a preliminary observation of its efficacy
CONDITIONS
Official Title
A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
- Histologically or cytologically confirmed advanced solid tumors with KRAS mutation or failure/no available standard therapy
- Toxicities from prior anticancer therapy must have resolved to Grade 1 or less (excluding hair loss)
- No prior chemotherapy or targeted therapies (except certain neoadjuvant or adjuvant therapies as specified)
- Prior radiotherapy allowed if bone marrow involvement is less than 25% and completed at least 4 weeks before enrollment with resolved acute toxicities
- Adequate organ function as defined by specific blood and biochemical lab criteria
- Female participants of childbearing potential must use reliable contraception and have negative pregnancy test within 7 days prior to enrollment; males must agree to use contraception during and 8 weeks after treatment
- Willingness to voluntarily participate, sign informed consent, comply with study procedures, and cooperate with follow-up
- Willingness to provide tumor tissue and blood samples for biomarker research when possible
You will not qualify if you...
- Symptomatic central nervous system metastases, leptomeningeal metastases, or spinal cord compression prior to consent
- Previous or current use of CDK4/6-targeted anticancer agents
- Molecular targeted therapy or radiotherapy within 2 weeks before screening; chemotherapy or immunotherapy within 3 weeks; nitrosoureas or mitomycin within 6 weeks
- Prior radical radiotherapy involving 25% or more of bone marrow
- Major surgery within 6 weeks before screening or planned within 12 weeks after starting study drug
- Participation in other clinical studies with active treatment within 28 days before study drug
- Uncontrolled fluid accumulations such as large pleural effusions or ascites
- Active inflammatory bowel disease, chronic diarrhea, intestinal obstruction, or swallowing difficulties affecting drug absorption
- Uncontrolled electrolyte imbalances
- History of severe allergic reactions
- Active hepatitis B or C infection or immunodeficiency
- Documented long QT syndrome or serious cardiac arrhythmias
- Severe lung disease including interstitial lung disease or severe COPD
- Pregnant or breastfeeding women; or unwillingness to use effective contraception
- Significant concurrent diseases posing safety risks or preventing study completion
- History of neurological or psychiatric disorders including epilepsy or dementia
- Other conditions deemed unsafe or inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Hongyun Zhao Hongyun Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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