Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Study Overview
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Brief Summary
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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

Official Title
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A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901 Administered Via Intravenous Infusion in Adult Patients With Selected Advanced Solid Tumors With a Cohort Expansion at the Recommended Phase 2 Dose

Conditions
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Advanced Cancer, Metastatic Cancer

Intervention / Treatment
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* Drug: Q901
* Drug: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation (Q901)<br> | Drug: Q901<br>* 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<br>|
| Experimental: Q901 Single-Agent Expansion Cohorts<br> | Drug: Q901<br>* 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<br>|
| Experimental: Q901 + Pembrolizumab Cohorts<br> | Drug: Q901<br>* 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<br>Drug: Pembrolizumab<br>* Pembrolizumab will be administered Q6W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 28 days of cycle 1 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the area under curve (AUC) of Q901 |  | 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 |  | 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 |  | 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 |  | Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days) |