BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

NCT05558982 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00005453
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

Metastatic Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 18 weeks

  18 weeks

Secondary Outcomes (6)

• Incidence of Adverse events

  From start of intervention until 30 days following discontinuation of intervention

• Objective response rate

  Through study completion, on average 18 weeks

• Median Duration of response (DOR)

  24 months

• Median Progression-free survival (PFS)

  24 months

• Median Overall survival (OS)

  24 months

Study Arms (1)

BXCL701 plus Pembrolizumab

EXPERIMENTAL

Drug: BXCL701; Drug: Pembrolizumab

Interventions

BXCL701 DRUG

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

BXCL701 plus Pembrolizumab

Pembrolizumab DRUG

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

Also known as: Keytruda

BXCL701 plus Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• BioXcel Therapeutics Inc: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Georgetown University: lead

Study Sites (3)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

PT-100 dipeptide; pembrolizumab

Study Officials

• Benjamin Weinberg, MD

  Georgetown University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 29, 2022
• Study Start: August 16, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)