Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients

NCT05634525 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 2022-0174NCI-2022-10011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if the investigational study drug, adagrasib (also called MRTX849), can help to control pancreatic cancer that has a KRAS G12 mutation. The safety and possible effects of adagrasib will also be studied.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  through study completion; an average of 1 year

Study Arms (1)

MRTX849 (Adagrasib)

EXPERIMENTAL

Helps to control pancreatic cancer that has a KRAS G12 mutation.

Drug: MRTX849

Interventions

MRTX849 DRUG

Given By PO

Also known as: Adagrasib

MRTX849 (Adagrasib)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of a pancreatic cancer with KRAS G12C mutation. Patients are eligible based on detection of KRAS G12C mutation in tumor tissue or plasma circulating tumor DNA (ctDNA) by any CLIA-certified lab assay.
• Unresectable or metastatic disease.
• Presence of tumor lesions to be evaluated per RECIST 1.1. Patients must have measurable or evaluable disease
• Age ≥ 18 years old
• Life expectancy of at least 3 months.
• No more than one prior therapy. Prior systemic therapy (e.g., chemotherapy, immunotherapy or, investigational agent) and radiation therapy discontinued at least 2 weeks before first dose date.
• Recovery from the adverse effects of prior therapy at the time of enrollment to ≤ Grade 1 (excluding alopecia and neuropathy).
• Eastern Cooperative Oncology Group (ECOG) performance status in 0 to 2.
• Laboratory values within the screening period:
• Absolute neutrophil count 1000/mm3 ( 1.0 x 109/L)
• Platelet count 75,000/mm3 ( 75 x 109/L)
• Hemoglobin ≥ 8 g/dL, in the absence of transfusions for at least 2 weeks
• Total bilirubin ≤2 x Upper Limit of Normal (ULN) (if associated with liver metastases or Gilbert's disease, ≤3 x ULN)
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤5 x ULN (if associated with liver metastases, ≤5 x ULN)
• Creatinine clearance ≥60 mL/min calculated using a validated prediction equation (e.g., Cockcroft-Gault, MDRD, or 24-hour urine CrCl) or serum creatinine 1.5XULN per institutional criterion.

You may not qualify if:

• Patients presenting with any of the following will be excluded from the study:
• Active brain metastases. Patients are eligible if brain metastases are adequately treated and patients are neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment) for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
• Carcinomatous meningitis
• History of significant hemoptysis or hemorrhage with Hemoglobin dropped below 8 g/dL within 4 weeks of the first dose date.
• Major surgery within 4 weeks of first dose date.
• Inability to swallow oral medications.
• Any of the following cardiac abnormalities:
• Unstable angina pectoris or myocardial infarction within the previous 6 months
• Congestive heart failure ≥NHYA Class 3 within the previous 6 months
• LVEF\<50%
• QTcF \> 480 milliseconds or medical or immediate family history of congenital Long QT Syndrome
• Symptomatic or uncontrolled atrial fibrillation or other arrhythmia
• History of stroke or transient ischemic attack within the previous 6 months.
• Ongoing need for a medication with any of the following characteristics that cannont be switched to alternative treatment prior to study entry: known risk of QT prolongation or Torsades de Pointes; substrate of CYP3A with narrow therapeutic index; strong inducer of CYP3A and/or P-gp; strong inhibitor of BCRP; and proton pump inhibitors (see Table 17 and Table 18).
• Second malignancy that either requires active concurrent systemic therapy or involves a lesion that may confound assessment of the pancreatic cancer under study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Mirati Therapeutics Inc.: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

adagrasib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Dan Zhao, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: May 3, 2023
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)