What side effects are associated with this type of intervention?

Common cancer treatments, including chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy often causes fatigue, nausea, vomiting, hair loss, and increased risk of infections. Targeted therapies, such as CDK7 inhibitors like Q901, can lead to side effects including fatigue, nausea, hyperglycemia, and decreased appetite. Immunotherapy, which includes agents like anti-PD-1 or anti-CTLA-4 antibodies, can cause immune-related adverse events such as pneumonitis, rash, pruritus, and diarrhea. These treatments aim to manage cancer effectively but come with varying degrees of side effects that need to be monitored and managed.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of various cancers. Pembrolizumab and nivolumab are notable immunotherapies approved for melanoma and other cancers, often used in combination with other agents like ipilimumab. Targeted therapies such as dabrafenib and trametinib are approved for BRAF V600-mutant melanoma, while PARP inhibitors like olaparib and niraparib are approved for ovarian cancer with specific genetic mutations. These approvals highlight the FDA's focus on precision medicine, targeting specific molecular pathways and genetic alterations in cancer treatment.

What other types of research exist?

Promising alternatives to Q901 for cancer treatment include: <ol> <li>Granulocyte colony-stimulating factor (G-CSF) with Emergency Use IND status.</li> <li></li> </ol> Pembrolizumab, particularly for PD-L1-positive tumors. 3. Atezolizumab, especially in combination with chemotherapy for high PD-L1 expression tumors. 4. Rucaparib for metastatic CRPC with HRR mutations. 5. Niraparib for metastatic CRPC with BRCA1 or BRCA2 mutations. 6. Vemurafenib plus rituximab for relapsed or refractory hairy cell leukemia.

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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

Must not have

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

Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any ongoing serious infections needing treatment.

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I have an active autoimmune or inflammatory disease that is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include targeted therapies, immunotherapies, and traditional chemotherapy. Targeted therapies, such as CDK7 inhibitors like Q901, work by specifically targeting molecular abnormalities in cancer cells, thereby inhibiting their growth and proliferation. Immunotherapies, including PD-1 inhibitors like pembrolizumab, enhance the body's immune response against cancer cells. Traditional chemotherapy uses cytotoxic agents to kill rapidly dividing cells, including cancer cells. These treatments are crucial for cancer patients as they offer more personalized and effective options, potentially improving therapeutic outcomes and reducing side effects compared to conventional treatments.

Current trends and future directions in the genetic therapy of human neoplastic disease.