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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT05394103Sponsor: Qurient Co., Ltd.Last updated: 2025-08-17

Summary

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

Arms & interventions

  • DrugQ901

    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

  • DrugKEYTRUDA® (pembrolizumab)

    KEYTRUDA® (pembrolizumab) will be administered Q6W

Outcome measures

Primary

  • 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

  • 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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (7)

Mayo Clinic

Phoenix, Arizona, 85054

Recruiting
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University of Southern California

Los Angeles, California, 90033

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Mayo Clinic

Jacksonville, Florida, 32224

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Northwestern University

Chicago, Illinois, 60611

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Mayo Clinic

Rochester, Minnesota, 55905

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Atlantic Health System Hospital

Morristown, New Jersey, 07960

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Mary Crowley Cancer Research

Dallas, Texas, 75230

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