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Recruiting NCT05394103

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Phase I / Phase II Interventional Advanced Cancer Metastatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Q901, KEYTRUDA® (pembrolizumab).
Who it may be relevant to
Registry conditions: Advanced Cancer, Metastatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose

Overview

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

Interventions

  • Drug Q901
    The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter
  • Drug KEYTRUDA® (pembrolizumab)
    KEYTRUDA® (pembrolizumab) will be administered Q6W

Primary outcome measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 28 days of cycle 1 (each cycle is 28 days)]
Secondary outcome measures (4)
  • Change in the area under curve (AUC) of Q901 [Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)]
  • Change in the maximum plasma concentration (Cmax) of Q901 [Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)]
  • Change in the time of maximum plasma concentration (Tmax) of Q901 [Time frame: Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)]
  • Tumor response using RECIST version 1.1 throughout study [Time frame: Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Mayo Clinic — Phoenix
  • University of Southern California — Los Angeles
  • Mayo Clinic — Jacksonville
  • Northwestern University — Chicago
  • Mayo Clinic — Rochester
  • Atlantic Health System Hospital — Morristown
  • Mary Crowley Cancer Research — Dallas
South Korea · 4 centers
  • National Cancer Center — Goyang-si
  • CHA University Bundang Medical Center — Seongnam-si
  • Asan Medical Center — Seoul
  • Severance Hospital — Seoul

Identifiers

NCT: NCT05394103 · QRNT-009 · MK-3475-E45 (KEYNOTE-E45)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗