Recruiting
Phase 1
Phase 2

Q901

Sponsor:

Qurient Co., Ltd.

Code:

NCT05394103

Conditions

Advanced Cancer

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Q901

KEYTRUDA® (pembrolizumab)

Study Details

Brief 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

Conditions

Advanced Cancer

Metastatic Cancer

Study ID

NCT05394103

Start date

Aug 30, 2022

Status verified date

Aug, 2025

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation (Q901)

experimental: Q901 Single-Agent Expansion Cohorts

experimental: Q901 + KEYTRUDA® (pembrolizumab) Cohorts

Interventions

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

KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab) will be administered Q6W

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 and Locations

Central contacts

Qurient Clinical Trial Information

+82-31-8060-1610clinicaltrial_info@qurient.com

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Atlantic Health System Hospital

Recruiting

Morristown, New Jersey, United States, 07960

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

More Information

Sponsor

Qurient Co., Ltd.

Last update posted

Aug 17, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Qurient Co., Ltd. on 2025-08-17.