Health TrialsbyHealthPanel

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

ConditionsAdvanced CancerMetastatic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQurient Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

130 Participants
are divided into 3 treatment groups
Group A: Dose escalation (Q901)Experimental treatment 1 intervention
Group B: Q901 Single-Agent Expansion CohortsExperimental treatment 1 intervention
Group C: Q901 + KEYTRUDA® (pembrolizumab) CohortsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qurient Co., Ltd.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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