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Metastatic Pancreatic CancerPhase 1NCT05634525

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

A Phase 1 study testing MRTX849 in people with Metastatic Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
MRTX849
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
3 May 2023to 21 Jul 2025
Phase
Phase 1
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 must meet all of the following inclusion criteria to be eligible for enrollment into the study.
  • 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.
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  • 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.
  • Women of child-bearing potential (WOCBP) or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a period of 6 months following termination of study treatment.
  • Completed informed consent process, including signing IRB/EC-approved informed consent form.
  • Willing to comply with clinical trial instructions and requirements.
  • Patients who are biologically capable of having children and sexually active must agree to use an acceptable method of contraception for the duration of the treatment period and for at least 6 months after the last dose of study treatment. The local Investigator will counsel the patient on selection of contraception method and instruct the patient in its consistent and correct use. Examples of acceptable forms of contraception include:
  • Oral, inserted, injected or implanted hormonal methods of contraception, provided it has been used for an adequate period of time to ensure effectiveness.
  • Correctly placed copper containing intrauterine device (IUD).
  • Male condom or female condom used WITH a spermicide.
  • Male sterilization with confirmed absence of sperm in the post-vasectomy ejaculate.
  • Bilateral tubal ligation or bilateral salpingectomy. The local Investigator will instruct the patient to call immediately if the selected birth control method is discontinued or if pregnancy is known or suspected.
  • Note: Women are considered post-menopausal and/or not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 months ago. In case of any ambiguity, the reproductive status of the woman should be confirmed by hormone level assessment.

Who cannot join

  • 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.
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  • 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.
  • Known active human immunodeficiency virus (HIV) or Hepatitis B or C. Note that the following are permitted:
  • Patients treated for hepatitis C with no detectable viral load;
  • Patients treated for HIV with no detectable viral load for at least 1 month prior to enrollment while on a stable regimen of agents that are not strong inhibitors of CYP3A4; and
  • Patients with hepatitis B (HBV) receiving prophylaxis against reactivation of hepatitis B (either [HBsAg-positive with normal ALT and HBV DNA < 2,000 IU/mL or < 10,000 copies/mL] or [HBsAg-negative and anti-HBc-positive]).
  • Pregnancy. WOCBP must have a negative serum or urine pregnancy test documented within the screening period prior start of study drug.
  • Breast-feeding or planning to breast feed during the study or within 6 months after study treatment.
  • Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the local Investigator's opinion, would be likely to interfere with the patient's participation in the study, or with the interpretation of the results.
  • Prior treatment with a therapy targeting KRAS G12C mutation is permitted

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

Primary Objectives:

To assess the preliminary antitumor activity of Adagrasib (MRTX849) monotherapy in metastatic pancreatic cancer patients with KRAS G12C mutation using Objective Response Rate (ORR) = Complete response (CR)+Partial response (PR) by RECIST 1.1 criteria1.

Secondary Objectives:

To evaluate the safety, tolerability and antitumor activity of Adagrasib (MRTX849) monotherapy in metastatic pancreatic cancer patients with KRASG12C mutation including median overall survival (OS), progression free survival (PFS), safety and adverse events (AEs).

Exploratory objectives:

Exploratory objectives include identiying the genomic and nongenomic mechanisms to responses and resistance and the specific immune cells involved with outcome.

Being tested
MRTX849
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • MRTX849Drug

    Also called Adagrasib

    Given By PO

Study groups in NCT05634525
Study groupRoleWhat they receive
MRTX849 (Adagrasib)ExperimentalHelps to control pancreatic cancer that has a KRAS G12 mutation.
Receives: Drug: MRTX849

What is being measured

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

  1. Overall survival (OS)

    Measured: through study completion; an average of 1 year

Timeline

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

  1. First posted2 Dec 2022
  2. Study start3 May 2023
  3. Primary completion21 Jul 2025
  4. Study completion21 Jul 2025

Why it stopped: No participants enrolled

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634525
Sponsor's protocol ID
2022-0174
Other IDs
NCI-2022-10011
Status last verified
Jul 2025
First submitted
22 Nov 2022
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MRTX849 in people with Metastatic Pancreatic Cancer, run by M.D. Anderson Cancer Center 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 26 inclusion and 23 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: withdrawn, as of the sponsor's last update on 25 Jul 2025. 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 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.

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 withdrawn before enrolling participants, so there are no results.

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?

Overall survival (OS) (time frame: through study completion; an average of 1 year). 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 NCT05634525.

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 25 Jul 2025.

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