Study of RP-6306 With FOLFIRI in Advanced Solid Tumors


About this study

The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

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:

- Male or female and ≥18 years-of-age at the time of signature of the informed consent

- Confirmed advanced solid tumors resistant or refractory to standard treatment

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

- All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s)
and radiographic evidence of progressing disease.

- Measurable disease as per RECIST v1.1

- Submission of available tumor tissue or willingness to have a biopsy performed if safe
and feasible

- Acceptable hematologic and organ function at screening

- Negative pregnancy test for women of childbearing potential at Screening and prior to
first study drug.

Exclusion Criteria:

- Inability to swallow and retain oral medications.

- Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-
lives, whichever is shorter, prior to first dose of study treatment.

- History or current condition, therapy, or laboratory abnormality that might confound
the study results, or interfere with the patient's participation for the full duration
of the study treatment.

- Patients who are pregnant or breastfeeding

- Life-threatening illness, medical condition, active uncontrolled infection, or organ
system dysfunction or other reasons which, in the investigator's opinion, could
compromise the participating patient's safety.

- Major surgery within 4 weeks prior to first study treatment dose.

- Uncontrolled, symptomatic brain metastases.

- Uncontrolled high blood pressure

- Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B
virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or
acquired immunodeficiency syndrome (AIDS) related illness.

- Moderate or severe hepatic impairment

- Cardiac diseases currently or within the last 6 months as defined by New York Heart
Association (NYHA) ≥Class 2

- Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the protocol and/or follow-up procedures outlined in the protocol.

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

Zhaohui Jin, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

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

International patient clinical studies questions