Actively Recruiting
Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-04-20
44
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.
CONDITIONS
Official Title
Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic lung adenocarcinoma (Stage IV/AJCC 8) without actionable driver mutations or with driver mutations but failed standard targeted therapies
- Refractory or intolerant to at least one established systemic treatment
- Measurable disease per RECIST v1.1 or evaluable disease in phase 1
- ECOG performance status of 0 to 1
- Life expectancy of at least 3 months
- Age 18 years or older
- Negative pregnancy test for females of childbearing potential
- Adequate liver function with specified limits for bilirubin, AST, ALT, and alkaline phosphatase
- Adequate renal function with creatinine clearance at least 30 mL/min
- Adequate blood counts: neutrophils ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥9 g/dL
- No significant abnormalities on urinalysis
- Acceptable coagulation status with PT ≤1.5x ULN and aPTT ≤1.5x ULN
- Non-fertile or agreement to use effective contraception during and 90 days after study
- Ability to swallow and tolerate oral medications
- Signed informed consent
- Willingness to consider biopsies if medically feasible (Expansion Cohort)
You will not qualify if you...
- Recent acute ischemic cardiac event or unstable angina within 3 months
- Abnormal left ventricular ejection fraction or symptomatic heart failure
- Uncontrolled cardiac disease or uncontrolled hypertension within 12 weeks
- History of significant bradycardia or conduction abnormalities requiring treatment
- Risk factors for QTc prolongation or prolonged QTc interval above specified limits
- Symptomatic central nervous system metastases requiring recent therapy
- Major surgery within 2 weeks prior to treatment
- Active uncontrolled infections requiring systemic therapy
- Pregnancy or nursing
- Recent radiation, chemotherapy, or investigational therapy within 28 days or 5 half-lives
- Inability or unwillingness to comply with study procedures
- Known infection with HIV, active hepatitis B or C (inactive hepatitis allowed)
- Serious nonmalignant diseases compromising study objectives
- Uncontrolled diarrhea grade 2 or higher
- Recent significant bleeding within 3 months
- Use of anticoagulants or anti-platelet agents except baby aspirin within 14 days
- Use of strong CYP3A4 inducers or inhibitors within 5 half-lives prior to treatment
- Concurrent investigational agents
- Allergic reactions to pacritinib, bemcentinib, or similar compounds
- Severe lactose intolerance or related digestive disorders as determined by PI
- Significant gastrointestinal surgery affecting absorption
- History of severe allergic reactions to sulfonamides
- Inability to discontinue H2-receptor antagonists or proton pump inhibitors 7 days before and during treatment
- Retinopathy or other ophthalmologic diseases not approved by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
K
Kayla Chamberlain
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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