CDK7 Inhibitor for Cancer

Recruiting at8 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Qurient Co., Ltd.

Disqualifiers: Cardiac disease, Infections, Autoimmune, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called Q901, both by itself and with another drug named pembrolizumab. It aims to see if these treatments are safe and can help treat cancer. Q901 might work by stopping tumor growth, while pembrolizumab helps the immune system fight cancer.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Pembrolizumab (Keytruda) in treating cancer?

Pembrolizumab has shown clinical activity in various solid tumors and is approved for treating certain types of lung cancer and melanoma. It works by blocking a pathway that tumors use to hide from the immune system, helping the body's defenses to attack the cancer. ^{1 2 3 4 5}

Is the CDK7 inhibitor, also known as Pembrolizumab or Keytruda, generally safe for humans?

Pembrolizumab (Keytruda) has been shown to be generally safe in humans, but it can cause some immune-related side effects. These include rare cases of type 1 diabetes and pneumonitis (lung inflammation), as well as more common side effects like fatigue, nausea, and rash. In nonhuman primate studies, no significant toxic effects were observed. ^{1 2 5 6 7}

What makes the drug Pembrolizumab unique for cancer treatment?

Pembrolizumab is unique because it is a type of immunotherapy that blocks the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively. This mechanism is different from traditional chemotherapy, which directly targets and kills cancer cells. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

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

Life expectancy of at least 3 months

Signed, written IRB-approved informed consent form

Exclusion Criteria

Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470 msec (females) and >450 msec (males)

I have not had serious heart problems or a heart attack in the last 6 months.

I do not have any ongoing serious infections needing treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive Q901 in a dose-escalation study to determine safety, tolerability, and pharmacokinetics

8-12 weeks

Dose Expansion

Participants receive Q901 at the recommended phase 2 dose (RP2D) to evaluate safety and potential antitumor activity

12-16 weeks

Combination Treatment

Participants receive Q901 in combination with pembrolizumab to evaluate safety and potential antitumor activity

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Pembrolizumab (Immunotherapy)
• Q901 (CDK7 Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Q901 Single-Agent Expansion Cohorts Experimental Treatment 1 Intervention

Group II: Q901 + KEYTRUDA® (pembrolizumab) Cohorts Experimental Treatment 2 Interventions

Group III: Dose escalation (Q901) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Qurient Co., Ltd.

Lead Sponsor

Trials

10

Recruited

840+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

A systematic review of four trials involving 3425 patients found that lower doses of pembrolizumab (2 mg/kg every 3 weeks) are equally effective as higher doses (10 mg/kg) in treating advanced melanoma and non-small-cell lung cancer (NSCLC).

The safety profile of pembrolizumab was similar across different doses, suggesting that the lower dose may be sufficient for routine treatment without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review. Abdel-Rahman, O.[2018]

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. Clotman, K., Janssens, K., Specenier, P., et al.[2022]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

Pembrolizumab, an immune checkpoint inhibitor, can cause pneumonitis in 1%-5% of patients, and this case report highlights an atypical presentation of this side effect in a patient with metastatic squamous cell carcinoma.

The patient was successfully treated with steroid therapy after ruling out other potential causes, leading to complete resolution of the pneumonitis, emphasizing the importance of recognizing and managing atypical cases of checkpoint inhibitor-pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. Jeon, WJ., Nguyen, J., Castillo, DR., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]