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Advanced Lung AdenocarcinomaPhase 1/2NCT06516887

Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

A Phase 1/2 study testing bemcentinib and pacritinib in people with Advanced Lung Adenocarcinoma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Lung Adenocarcinoma
What is being tested?
bemcentinib and pacritinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
27 Dec 2024to 21 May 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically-or cytologically confirmed diagnosis of locally advanced and/or metastatic lung adenocarcinoma (Stage IV/AJCC Edition 8) (any PD-L1 status) without actionable driver mutations, who has failed at least one line of systemic treatment. Patients with locally advanced and/or metastatic lung adenocarcinoma with driver mutation who have failed standard targeted therapies can also be enrolled on this study.
  • Be refractory to, or intolerant of, an established therapy known to provide clinical benefit for their condition. Patients can be eligible for study if they have failed at least one line of treatment.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator. Evaluable disease in phase 1 is allowed.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (AppendixH)
  • Life expectancy of at least 3 months
  • Be ≥18 years of age
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  • Negative pregnancy test (if female of childbearing potential)
  • Adequate liver function:
  • Total bilirubin \<1.5x upper limit of normal (ULN) (\<3xULN for subjects with liver metastases)
  • Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase \<2.5 x ULN.
  • If liver metastases are present, then AST and ALT \<5 x ULN is allowed.
  • Adequate renal function with calculated creatinine clearance ≥30 mL/min by Cockcroft-Gault Formula.
  • Adequate hematologic status:
  • Absolute neutrophil count ≥1500 cells/mm3
  • Platelet count ≥100,000 (plt/mm3)
  • Hemoglobin ≥9 g/dL
  • Have no clinically significant abnormalities on urinalysis
  • Have acceptable coagulation status:
  • Prothrombin time (PT) ≤ 1.5 x ULN
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
  • Be non-fertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an highly effective method of contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation and for at least 90 days after the last study drug dose. Female patients using hormonal contraceptive agent should use at least one additional non-hormonal method of contraception (e.g., IUD, condom, abstinence). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Have read and signed the IRB-approved informed consent form prior to any study related procedure. If a patient is re-screened for the clinical trial or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.
  • Patients enrolled in the Expansion Cohort must be willing to consider pre-study and on-study biopsies, if safe and medically feasible, as determined by a board-certified interventional radiologist. Four to eight core samples will be requested at each biopsy timepoint.
  • Patients must be able to swallow and tolerate oral medications.

Who cannot join

  • History of the following cardiac conditions:
  • An acute ischemic cardiac event (e.g., myocardial infarction) or hospitalization for unstable angina within 3 months prior to first dose.
  • Abnormal left ventricular ejection fraction on echocardiography (less than the lower limit of normal for a subject of that age at the treating institution or Grade 2 severity according to the New York Heart Association as defined by symptoms at less than ordinary levels of activity. Echo will only be considered for symptomatic patients with heart disease and concerns for heart failure. The Echo would be ordered by PI as standard of care.
  • Uncontrolled cardiac disease, including unstable angina, uncontrolled hypertension (i.e., sustained systolic BP \>160 mmHg or diastolic BP \>90 mmHg), or need to change medication due to lack of disease control within 12 weeks prior to the provision of consent.
  • History or presence of bradycardia (≤55 bpm) or history of symptomatic bradycardia, left bundle branch block, cardiac pacemaker or significant atrial tachyarrhythmias as defined by the need for treatment.
  • Presence of any factors that increase the risk for QTc prolongation, e.g., resistant, or inadequately treated heart failure, presence of hypokalemia or hypomagnesemia not corrected by, or not responding to, replacement therapy or inadequately treated hypothyroidism as defined by the thyroid-stimulating hormone not within the expected range of the institution.
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  • Family history of long QTc syndrome or ventricular arrhythmias; personal history of long QTc syndrome or previous drug induced QTc prolongation of at least Grade 3 (QTc \>500 ms). (Appendix I)
  • Have a corrected QT interval (QTcF, Fridericia's method) of \>450 msec in men and \>470 msec in women.
  • Presence of symptomatic central nervous system metastatic disease that requires local therapy such as radiotherapy, surgery, or increasing dose of steroids within 2 weeks prior to Day 1 treatment.
  • Have undergone major surgery, other than diagnostic surgery, within 2 weeks prior to Day 1
  • Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  • Are pregnant or nursing.
  • Received treatment with radiation therapy, chemotherapy, or investigational therapy within 28 days or 5 half-lives, whichever occurs first, prior to study entry.
  • Are unwilling or unable to comply with procedures required in this protocol.
  • Have known infection with human immunodeficiency virus, hepatitis B, or hepatitis C. Patients with history of chronic hepatitis that is not active are eligible.
  • Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure (Child Pugh class B or C), or other conditions) that could compromise protocol objectives in the opinion of the clinical investigators.
  • Uncontrolled diarrhea (grade ≥ 2).
  • Recent bleeding (grade ≥2 within the past 3 months unless precipitated by another event (e.g., trauma, surgery).
  • Use of anticoagulant or anti-platelet agents within the prior 14 days other than baby aspirin.
  • Use of strong CYP3A4 inducers or inhibitors within 5 half-lives prior to cycle 1 day 1 treatment. Patients enrolled in PK study should not be taking a moderate/severe CYP3A4 inhibitor or inducer.
  • Are currently receiving any other investigational agent.
  • Have exhibited allergic reactions to a similar structural compound or formulation as pacritinib or bemcentinib.
  • Patients with severe lactose intolerance, hereditary galactose intolerance, LAPP-lactase deficiency and/or glucose-galactose malabsorption at the discretion of the PI\>.
  • Have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.
  • Have a history of severe adverse reaction (e.g., hypersensitivity reaction, anaphylaxis) to sulfonamides.
  • Patients who are currently taking H2-receptor agonists (e.g., cimetidine, ranitidine) or proton pump inhibitors (e.g., omeprazole) must be able to discontinue their use at least seven days prior to the first dose of study treatment and throughout the period they are receiving study treatment. Patients who are unable to do so will be deemed ineligible.
  • Patients with retinopathy. Other ophthalmologic diseases may be allowed at the investigator's discretion.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase Ib/II Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Efficacy Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.

Read the detailed description

Specific Aim 1. Determine the safety, tolerability and maximum tolerated dose (MTD) of pacritinib in combination with bemcentinib in patients with advanced lung adenocarcinoma. We propose a prospective, open-label, phase Ib trial to evaluate safety, tolerability and MTD of pacritinib (JAK2 inhibitor) in combination with bemcentinib (AXL inhibitor) in patients with treatment refractory lung adenocarcinoma. The primary objectives of the phase Ib study are to determine the maximum tolerated dose (MTD), pharmacokinetics/pharmacodynamics (PK/PD), dose-limiting toxicities (DLTs) and efficacy of oral pacritinib in combination with bemcentinib. This phase Ib part of the study will use a Bayesian Optimal Interval (BOIN)70 design to determine MTD. This Bayesian dose-finding approach combines the ease of implementation of the traditional "3+3" design with the improved performance of more complex model-based designs in terms of accurately identifying the MTD. Compared to the modified probability toxicity interval design, it has a substantially lower risk of overdosing patients and generally has a higher probability of correctly selecting the MTD. In the phase Ib part of the study, subjects with advanced lung adenocarcinoma will be treated with pacritinib in combination with bemcentinib at increasing doses until MTD for combination treatment has been established. Six dose levels of combination treatments will be considered.

Being tested
bemcentinib, pacritinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bemcentinibDrug

    Bemcentinib has been investigated in a phase I/II clinical trials for solid tumors. Phase I and II clinical studies of BGB324 are ongoing in non-small cell carcinoma, in which combinations with other agents such as Phase I study of docetaxel (NCT02922777), erlotinib (NCT02424617), and pembrolizumab (NCT03184571) are also being investigated. In a phase I dose escalation study of bemcentinib in combination with docetaxel study, patients with treatment naïve, advanced lung adenocarcinoma receive docetaxel 75 mg/m2 given IV every 21 days in combination with bemcentinib. Bemcentinib dose will be escalated in a standard 3+3 fashion until a maximum tolerated dose is determined.

  • pacritinibDrug

    For use in clinical studies as an oral agent, pacritinib is supplied as size #0 hard gelatin capsules with gray bodies and scarlet caps. Capsules contain 100 mg pacritinib (free base) and the following inactive ingredients: microcrystalline cellulose NF, polyethylene glycol 8000 NF, and magnesium stearate NF. The capsule gelatin is bovine derived. Pharmacies at investigational sites will receive subject-specific bottles containing 120 capsules packaged in 200 mL high-density polyethylene bottles with child-resistant closures.

Study groups in NCT06516887
Study groupRoleWhat they receive
Pharmacokinetic Phase 1b (PK) Study CohortExperimentalPatients will receive bemcentinib and pacritinib in combination from Days 1 to Day 28. PK samples will be collected on Day 1 (pre-dose, 4, 6h), pre-dose Day 2, Day 7 (pre-dose, 4h and 6h post-dose), pre-dose Day 8, pre-dose Day 14, and Day 22 (pre-dose and 6h post-dose) samples. The Day 22 sample will cover the steady state values for both compounds. Six dose levels of combination treatments will be considered: * Dose level -1: pacritinib 100 mg oral dose (p.o.) daily + bemcentinib 50 mg p.o. daily; * Dose level 1: pacritinib 100 mg oral dose (p.o.) twice daily (BID) + bemcentinib 50 mg p.o. daily; * Dose level 2: pacritinib 100 mg p.o. BID + bemcentinib 75 mg p.o. daily; * Dose level 3: pacritinib 100 mg BID + bemcentinib 100 mg p.o. daily; * Dose level 4: pacritinib 200 mg BID + bemcentinib 100 mg p.o. daily; * Dose level 5: pacritinib 200 mg BID + bemcentinib 125 mg p.o. daily.
Receives: Drug: bemcentinib; Drug: pacritinib
Phase II CohortExperimentalOf these participants taking the Maximum tolerated dose, up to 15 will undergo a biopsy. Progression free survival will be the primary objective of this study phase.
Receives: Drug: bemcentinib; Drug: pacritinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS will be defined as the time from the date of randomization to the date of disease progression or death (any cause), whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD will be censored in the PFS analysis at the last known date the subject was documented progression free prior to completing follow-up or initiating the new therapy.

    Measured: Up to 48 months

  2. Overall Response Rate

    Overall response rate is defined as the proportion of patients who have a partial or complete response to therapy.

    Measured: Up to 48 months

Secondary outcomes (2)

  1. Overall Survival (OS)

    The time from randomization to death from any cause

    Measured: Up to 48 months

  2. Clinical Benefit Rate

    The percentage of patients with metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start27 Dec 2024
  3. Primary completion21 May 2026
  4. Study completion21 May 2026

Why it stopped: Investigational drug limitations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase 1b of the study will be conducted to establish the maximum tolerable dose, after pharmacokinetic samples from the first 10 subjects have been collected they will commence Cycle 1, Day 1 treatment. Phase 2 will then be enrolled in a single arm comparison study where some patients will be selected to undergo biopsy.
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516887
Sponsor's protocol ID
CTMS# 24-0020
Other IDs
5R01CA269766-02
Status last verified
Apr 2026
First submitted
9 Jul 2024
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bemcentinib and pacritinib in people with Advanced Lung Adenocarcinoma, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Investigational drug limitations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06516887.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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