A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

Overview

About this study

The purpose of this study is to characterize the safety and tolerability of MRTX0902 as monotherapy or in combination with selected cancer therapeutic agents in patients having advanced solid tumor malignancies harboring mutations in the KRAS-MAPK pathway.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Histologically confirmed diagnosis of a solid tumor malignancy with any of the
following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved
test:

1. MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating
SOS1, PTPN11, or EGFR mutation, or known annotated recurrent inactivating NF1
mutation;

2. MRTX0902 and adagrasib combination therapy: KRAS G12C mutation.

- Unresectable or metastatic disease

- No available treatment with curative intent; standard treatment is not available or
patient declines

- Presence of tumor lesions to be evaluated per RECIST 1.1:

1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease

2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable disease

- Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation
at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate organ function

Exclusion Criteria:

- Active brain metastases or carcinomatous meningitis

- Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and
adagrasib combination, and Phase 2 cohorts only)

- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of
study treatment.

- Major surgery within 4 weeks of first dose of study treatment

- History of pneumonitis or interstitial lung disease

- Ongoing need for medication with following characteristics: substrate of CYP3A; strong
inducer or inhibitor or CYP3A and/or P-gp; strong inhibitors of BRCP and proton pump
inhibitors

- Cardiac abnormalities

- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or
other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption
syndrome) likely to alter absorption of study treatment or result in inability to
swallow oral medications

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Leventakos, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available