Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Qurient Co., Ltd.
Study ID
NCT05394103
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Q901 — DRUG
    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
  • KEYTRUDA® (pembrolizumab) — DRUG
    KEYTRUDA® (pembrolizumab) will be administered Q6W

Study Details

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

Key Dates

Start date
Aug 30, 2022
Status verified
Aug 2025
Primary completion
Dec 30, 2025
Completion
Aug 30, 2026

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation (Q901)
  • Experimental: Q901 Single-Agent Expansion Cohorts
  • Experimental: Q901 + KEYTRUDA® (pembrolizumab) Cohorts

Primary Outcome Measure

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) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
See Central Contact
University of Southern CaliforniaLos AngelesCalifornia90033
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Mayo ClinicJacksonvilleFlorida32224
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Northwestern UniversityChicagoIllinois60611
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Mayo ClinicRochesterMinnesota55905
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Atlantic Health System HospitalMorristownNew Jersey07960
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Mary Crowley Cancer ResearchDallasTexas75230
See Central Contact

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