Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma

NCT07475234 | Not Yet Recruiting Phase 1

• 1 other identifier: E20260288
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy and safety of Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Time from randomization to disease progression or death from any cause, assessed per RECIST v1.1 and evaluated every 6 weeks during treatment and follow-up.

  From randomization to disease progression or death, with follow-up for up to 2 years after treatment initiation.

Study Arms (1)

Single-Arm

EXPERIMENTAL

Patients receive Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer, with assessment of efficacy and safety outcomes.

Drug: Rimegepant plus Nab-Paclitaxel and Gemcitabine

Interventions

Rimegepant plus Nab-Paclitaxel and Gemcitabine DRUG

Rimegepant 75 mg every other day. Nab-paclitaxel 125 mg/m² and Gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of a 21-day cycle.

Single-Arm

Eligibility Criteria

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

You may qualify if:

• The patient has good compliance, understands the study procedures, and has signed a written informed consent form.
• Age ≥ 18 years.
• Pathologically or cytologically confirmed pancreatic cancer, with imaging or pathological findings indicating unresectable pancreatic cancer with distant metastasis.
• Patients who have not received any prior treatment for pancreatic cancer (including radiotherapy, chemotherapy, or experimental therapy), except for surgical resection.
• If the patient has received neoadjuvant/adjuvant chemotherapy, the regimen must not contain AG, and the interval from the last administration to the diagnosis of recurrence must be \>6 months, with no delayed toxicities.
• The patient has at least one measurable lesion according to the RECIST 1.1 criteria.
• ECOG performance status 0-1.
• Expected survival \>3 months.
• Adequate organ function, defined as meeting the following criteria (blood tests to be completed within 14 days prior to enrollment):
• Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
• Hemoglobin ≥90 g/dL
• Platelet count (PLT) ≥100 × 10⁹/L
• Total bilirubin \<1.5 × upper limit of normal (ULN)
• Liver transaminases (AST \& ALT) \<2.5 × ULN; for patients with liver metastases, AST/ALT ≤5 × ULN
• Serum creatinine ≤1 × ULN, or creatinine clearance ≥50 mL/min if serum creatinine \>1 × ULN

You may not qualify if:

• Patients with a history of other malignancies within the past 5 years, except for cured in situ carcinoma or basal cell carcinoma of the skin.
• Patients diagnosed with pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.
• Patients with refractory pleural effusion or ascites.
• Patients with known brain or meningeal metastases.
• Patients who used strong CYP3A4 inducers within 3 weeks prior to the first study drug administration, or strong CYP3A4/UGT1A1 inhibitors within 3 weeks prior to the first study drug administration.
• Patients who underwent major organ surgery (excluding needle biopsy, central venous catheter insertion, port catheterization, biliary obstruction stenting, percutaneous transhepatic biliary drainage, and cholecystostomy) within 4 weeks prior to the first dose of study drug, or who plan to undergo elective surgery.
• Patients with known dihydropyrimidine dehydrogenase deficiency or low activity.
• Patients with active infection, including HIV infection, or chronic HBV/HCV in the active phase (HBV DNA ≥10⁴ copies/mL or ≥2000 IU/mL; patients must receive antiviral therapy first, and can only be enrolled when HBV DNA \<10⁴ copies/mL or \<2000 IU/mL, with continued antiviral therapy and monitoring of liver function and HBV viral load).
• Patients with severe comorbidities, including poorly controlled diabetes despite anti-diabetic medication, clinically significant active heart disease, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, hemorrhagic peptic ulcer, ileus, or intestinal obstruction.
• Patients with severe diarrhea (grade ≥2 per NCI-CTCAE v5.0: ≥4 bowel movements per day vs baseline; moderate/severe increase in stoma output; limitation of activities of daily living).
• Patients with severe psychiatric disorders.
• Patients with grade ≥II peripheral neuropathy at present or in the past.
• Patients with known hypersensitivity to benzodiazepines, AG chemotherapy agents, or related components.
• Patients who participated in other clinical trials within 4 weeks prior to enrollment.
• Patients deemed unsuitable for the trial by the investigator.

Sponsors & Collaborators

• Xiuchao Wang: lead

MeSH Terms

Interventions

rimegepant sulfate; 130-nm albumin-bound paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Xiuchao W Chief Physician

CONTACT

+86 13752038814; wangxiuchao2008@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director, Pancreatic Cancer Prevention and Treatment Center

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03