Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Overview

About this study

The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies with MTAP (methylthioadenosine phosphorylase) deletion.

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 homozygous
deletion of the MTAP gene detected in tumor tissue or ctDNA.

- Unresectable or metastatic disease.

- Patients must have received standard therapies appropriate for their tumor type and
stage with disease progression on or after the most recent treatment.

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.

- Age ≥ 18 years.

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

- Adequate organ function.

Exclusion Criteria:

- Prior treatment with a PRMT5 or MAT2A inhibitor therapy (Phase 2 only).

- Active brain metastases or carcinomatous meningitis.

- 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 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.

- Cardiac abnormalities.

Eligibility last updated 7/14/22. 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.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yujie Zhao, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vinicius Ernani, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions