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Immunotherapy

CDK7 Inhibitor for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Qurient Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1 and day 22, cycle 2 day 8 and day 22 (each cycle is 28 days)

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective against cancer.

Who is the study for?

Adults with certain advanced cancers (like ovarian, prostate, breast, endometrial, colorectal, lung or pancreatic) that have worsened after standard treatments or have no beneficial standard treatment available. They should be relatively active and able to care for themselves (ECOG status 0-2), expect to live at least 3 more months and must sign a consent form.Check my eligibility

What is being tested?

The trial is testing Q901 alone and in combination with Pembrolizumab on various advanced solid tumors. It's an early-phase study to find the right dose based on safety and how well patients tolerate it while also looking for signs of tumor shrinkage.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system since Pembrolizumab boosts its activity. For Q901 as a new drug, side effects are being studied but may involve typical cancer therapy issues like fatigue, nausea or blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened after standard treatment or there's no beneficial standard treatment available.

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I am 18 years old or older.

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I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1 and day 22, cycle 2 day 8 and day 22 (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1 and day 22, cycle 2 day 8 and day 22 (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 and day 22, cycle 2 day 8 and day 22 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary outcome measures

Change in the area under curve (AUC) of Q901

Change in the maximum plasma concentration (Cmax) of Q901

Change in the time of maximum plasma concentration (Tmax) of Q901

+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

3Treatment groups

Experimental Treatment

Group I: Q901 Single-Agent Expansion CohortsExperimental Treatment1 Intervention

Group II: Q901 + KEYTRUDA® (pembrolizumab) CohortsExperimental Treatment2 Interventions

Group III: Dose escalation (Q901)Experimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,541 Total Patients Enrolled

Qurient Co., Ltd.Lead Sponsor

8 Previous Clinical Trials

677 Total Patients Enrolled

Media Library

Pembrolizumab (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05394103 — Phase 1 & 2

Cancer Research Study Groups: Q901 Single-Agent Expansion Cohorts, Q901 + KEYTRUDA® (pembrolizumab) Cohorts, Dose escalation (Q901)

Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05394103 — Phase 1 & 2

Pembrolizumab (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05394103 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an upper limit to the amount of individuals involved in this experiment?

"The study must find 70 enrollees who meet the criteria set by the sponsor, Qurient Co., Ltd.. These locations that shall be running this trial include Mayo Clinic in Phoenix and University of Southern California in Los Angeles."

Answered by AI

In which geographic areas is this experiment accessible?

"This clinical trial runs at 6 medical sites, such as Mayo Clinic in Phoenix, University of Southern California in Los Angeles and Atlantic Health System Hospital in Rochester. In addition to these 3 centres, there are a further 3 operational locations."

Answered by AI

Is there currently an opportunity for individuals to participate in this clinical experiment?

"Affirmative. Clinicaltrials.gov information indicates that this trial, initially posted on August 30th 2022, is presently accepting participants. The study necessitates 70 patients to be enrolled across 6 medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

2022. "Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05394103.