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Metastatic Pancreatic Ductal AdenocarcinomaPhase 2EXPEL PANCNCT05558982

BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 2 study testing BXCL701 and Pembrolizumab in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Georgetown University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Single-arm, open label study to determine the 18 week progression-free survival rate of the combination of BXCL701 and pembrolizumab in patients with pancreatic ductal adenocarcinoma in the second-line metastatic setting. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BXCL701 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
16 Aug 2023to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Histologically-confirmed pancreatic ductal adenocarcinoma with metastatic disease (mixed histology is acceptable as long adenocarcinoma is the dominant histological subtype)
  • Patient must consent to two mandatory biopsies and have tumor amenable to serial core biopsies
  • Measurable disease by iRECIST v. 1.1 criteria (tumor ≥ 1 cm in longest diameter on axial image on CT or MRI and/or lymph node(s) ≥ 1.5 cm in short axis on CT or MRI) on baseline imaging
  • Documented progression of disease or intolerance on at least one regimen for metastatic disease (progression during or within 3 months of the completion of adjuvant therapy is acceptable)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (see Table 2)
  • Age ≥ 18 years
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  • Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery (SRS) at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease
  • Patients with available standard 12-lead ECG with the following parameters at screening (defined as the mean of the triplicate ECGs):
  • o QTcB (Bazett's formula) interval at screening <480msec
  • Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3; Platelets ≥100 × 109/L; hemoglobin ≥ 8.0 g/dL (with no prior red blood cell transfusions during the prior 14 days)
  • Renal function: serum creatinine ≤ 1.5 × upper normal limit of institution's normal range or creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
  • Hepatic function: AST and ALT ≤ 3.0 × the upper normal limit of institution's normal range. Total bilirubin ≤ 1.5 × the upper normal limit of institution's normal range. For subjects with liver metastases, AST and ALT < 5 × the upper normal limit of institution's normal range, and total bilirubin >1.5 - 3.0 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.
  • Patients must have fully recovered from all effects of surgery. Patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy. Minor procedures requiring "Twilight" sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator.
  • Women of childbearing potential must have a negative serum pregnancy test during the screening period and on C1D1 and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
  • Patient is capable of swallowing pills whole.
  • Patient is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
  • Patient's acute toxic effects of previous anticancer therapy have resolved to ≤ Grade 1 except for Grade 2-3 peripheral neuropathy or any grade of alopecia.
  • Male patients and their female partners of childbearing potential must agree and commit to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/ suppository) throughout the duration of the study until at least 6 months following the last dose of study drug, in addition to their female partners using either an intrauterine device or hormonal contraception and continuing until at least 6 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy >6 months before signing the informed consent form.

Who cannot join

  • Patients previously exposed to FAP inhibitors, DPP inhibitors, or monoclonal antibodies targeting anti-PD-1, anti-PD-L1, or anti-CTLA-4.
  • Prior anti-tumor therapy within 2 weeks of C1D1 (defined as, but not limited to, anti-cancer agents (cytotoxic chemotherapy, immunotherapy, and biologic therapy), radiotherapy, and investigational agents), the "washout period."
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic symptomatic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infection).
  • Women who are pregnant or breastfeeding.
  • Psychiatric illness or social situation that would limit compliance with study requirements.
  • Concurrent malignancy or malignancy within 2 years prior to C1D1, with the exception of adequately treated cutaneous basal or squamous cell carcinoma, non-melanomatous skin cancer, curatively resected cervical cancer, or any locally treated malignancy deemed low likelihood for recurrence or metastasis by the investigator.
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  • Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
  • At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment
  • Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Patient has a known history of HIV infection or chronic, active hepatitis B or C (testing is not mandatory) - patients with hepatitis C status-post treatment with undetectable viral load are eligible.
  • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
  • Patient has uncontrolled, clinically significant pulmonary disease (e.g. chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the investigator would put the patient at significant risk for pulmonary complications during the study.
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormalities, including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Documented cardiomyopathy
  • Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening
  • Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block)
  • Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
  • Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
  • Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication
  • Inability to determine the QT interval on screening
  • Patients with history of symptomatic orthostatic hypotension within 3 months prior to enrollment, defined as a drop in systolic blood pressure (SBP) of ≥ 20 mmHg or diastolic blood pressure (DBP) of ≥ 10 mmHg with assumption of an upright posture.
  • Patients with a history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or those who have a history of interstitial lung disease.
  • Patients who have received a live-virus vaccination within 30 days of planned treatment start date.
  • Patient must not have active known or suspected autoimmune disease requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (e.g., celiac disease) are permitted to enroll.
  • Patient must not have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses ≤10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Prisoners.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Georgetown Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Phase II Trial of BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Single-arm, open label study to determine the 18 week progression-free survival rate of the combination of BXCL701 and pembrolizumab in patients with pancreatic ductal adenocarcinoma in the second-line metastatic setting.

Being tested
BXCL701, Pembrolizumab
Keywords
Metastatic Pancreatic Ductal Adenocarcinoma

What participants receive

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

  • BXCL701Drug

    BXCL701 0.3 mg, orally, twice a day on days 1-14 every 21 days

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab 200 mg intravenous (IV) on day 1 every 21 days.

Study groups in NCT05558982
Study groupRoleWhat they receive
BXCL701 plus PembrolizumabExperimentalNot described
Receives: Drug: BXCL701; Drug: Pembrolizumab

What is being measured

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

  1. Progression-free survival at 18 weeks

    Measured: 18 weeks

Secondary outcomes (6)

  1. Incidence of Adverse events

    Adverse events as per CTCAE v. 5.0

    Measured: From start of intervention until 30 days following discontinuation of intervention

  2. Objective response rate

    Objective response by iRECIST v. 1.1

    Measured: Through study completion, on average 18 weeks

  3. Median Duration of response (DOR)

    Measured: 24 months

  4. Median Progression-free survival (PFS)

    Measured: 24 months

  5. Median Overall survival (OS)

    Measured: 24 months

  6. Change in tumor marker (CA19-9)

    Best change in tumor marker

    Measured: Through study completion, on average 18 weeks

Timeline

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

  1. First posted29 Sep 2022
  2. Study start16 Aug 2023
  3. Primary completion31 Dec 2025
  4. Study completionSep 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05558982
Sponsor's protocol ID
STUDY00005453
Acronym
EXPEL PANC
Status last verified
Sep 2026
First submitted
2 Sep 2022
Last updated
14 Sep 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 2 study testing BXCL701 and Pembrolizumab in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Georgetown University 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 18 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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 at 18 weeks (time frame: 18 weeks). 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 NCT05558982.

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 14 Sep 2026.

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