Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Overview

About this study

The purpose of part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter.

The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, an expansion phase at the established RP2D will be undertaken in participants with selected advanced solid tumors. In Part 2 Cohort 2, a safety run in and expansion phase will be undertaken with Q901 at the RP2D administered in combination with pembrolizumab (400 mg Q6W) in participants with advanced solid tumors.

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:

- Participants with histologically or cytologically confirmed advanced or metastatic
ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or
pancreatic cancer, who have progressed following standard-of-care therapy or for whom
there is no standard therapy that confers clinical benefit

- Measurable disease per RECIST v 1.1

- ECOG performance status 0,1 or 2

- Life expectancy of at least 3 months

- Age ≥ 18 years

- Signed, written IRB-approved informed consent form

Exclusion Criteria:

- New York Heart Association Class III or IV cardiac disease, or myocardial infarction,
severe unstable angina, coronary/peripheral artery bypass graft, congestive heart
failure within the past 6 months

- Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470
msec (females) and >450 msec (males)

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy

- Active, poorly controlled autoimmune or inflammatory diseases

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

Eligibility last updated 3/26/2024. 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 Hao Xie, M.D., Ph.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Jacksonville, Fla. Mayo Clinic principal investigator Hani Babiker, M.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Mitesh Borad, M.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hao Xie, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Babiker, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials