Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Qurient

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Metastatic Cancer; Advanced Cancer

Treatments: Drug: KEYTRUDA® (pembrolizumab); Drug: Q901

Study type: Interventional

Funder types: Industry

Identifiers

NCT05394103

MK-3475-E45 (KEYNOTE-E45) (Other Identifier)

QRNT-009

Details and patient eligibility

About

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

Dose escalation (Q901)

Experimental group

Treatment:

Drug: Q901

Q901 Single-Agent Expansion Cohorts

Experimental group

Treatment:

Drug: Q901

Q901 + KEYTRUDA® (pembrolizumab) Cohorts

Experimental group

Treatment:

Drug: KEYTRUDA® (pembrolizumab)

Drug: Q901