Recruiting

MEK Inhibitor

Sponsor:

Mandana Kamgar, MD

Code:

NCT05630989

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

combination therapy with no MEKi

combination therapy with MEKi-HCQ

combination therapy with MEKi-EGFRi

combination therapy with MEKi.

Study Details

Brief summary:

This is an observational precision oncology study designed to collect and analyze data that allows us to characterize the safety and efficacy of several different mitogen-activated protein kinase kinase inhibitor (MEKi) -based treatment strategies and the feasibility of administering MEKi combination therapies to patients with KRAS G12R mutated advanced pancreatic ductal adenocarcinoma (PDAC).

Conditions

Pancreatic Ductal Adenocarcinoma

Study ID

NCT05630989

Start date

Feb 7, 2023

Status verified date

Apr, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years.
2. Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treating physician or tumor board.
3. Tumor must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician.
4. Ability to understand a written informed consent document and the willingness to sign it.

Exclusion Criteria:

1. Age <18 years.
2. Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma
3. Tumor does not have a KRAS G12R mutation.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Therapy with no MEKi

Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with no MEKi.

Therapy with MEKi- Hydroxychloroquine (HCQ)

Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with MEKi and HCQ.

Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi)

Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and EGFRi.

Therapy with MEKi-Other

Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and a specified drug combination.

Interventions

combination therapy with no MEKi

This cohort will receive combination therapy with no MEKi.

combination therapy with MEKi-HCQ

This cohort will receive combination therapy with MEKi-HCQ.

combination therapy with MEKi-EGFRi

This cohort will receive combination therapy with MEKi-EGFRi.

combination therapy with MEKi.

This cohort will receive combination therapy with MEKi.

Primary outcome measure

  • The number of subjects with no progression. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Mandana Kamgar, MD, MPH

414-805-4600mkamgar@mcw.edu

Locations

Froedtert Hospital and the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Mandana Kamgar, MD

414-805-4600mkamgar@mcw.edu

More Information

Sponsor

Mandana Kamgar, MD

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Pancreatic Ductal Adenocarcinoma
  • KRAS G12R mutation
  • Precision medicine
  • Retrospective Chart Review
  • Prospective Chart Review

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mandana Kamgar, MD on 2026-05-05.