A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations

Plain English Summary

A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors is a Phase 1 clinical trial sponsored by Cogent Biosciences, Inc. studying PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2-low Breast Cancer. This trial tests a new drug called CGT6297 for adults with advanced solid tumors that have specific PIK3CA gene changes. It is for patients with certain types of advanced endometrial cancer, breast cancer (HR-positive/HER2-negative or HER2-low), or other solid tumors with PIK3CA mutations. Participation involves taking the study drug daily; the exact treatment plan will be determined by the study phase. Alternative treatments depend on the specific cancer type and previous treatments received. The trial aims to enroll 90 participants.

Official Summary

This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with advanced solid tumors that have been confirmed to have PIK3CA mutations. Patients with specific types of endometrial cancer, breast cancer, or other solid tumors like head and neck or colorectal cancers with PIK3CA mutations. Individuals who have either not responded to or cannot tolerate standard treatments, or for whom standard first-line treatment is not suitable. Patients must have tumors that can be measured and generally be in good health with a performance status of 0 or 1. This trial is studying PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2-low Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures will assess how safe the drug is and how well it works by looking at tumor shrinkage and response rates. The specific primary outcome measures are: Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a] (Approximately 12 months); Overall Response Rate [Phase 1b] (Approximately 8 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial addresses a need for new treatments for advanced solid tumors driven by PIK3CA mutations, a common genetic change in many cancers. This research targets PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2-low Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial is investigating a targeted therapy for a specific genetic mutation, indicating a focus on precision medicine in oncology with potential for a significant market if successful. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your tumor has a PIK3CA mutation and if this trial is a good option for you. Be prepared to take the study drug (CGT6297) by mouth every day. You will have regular check-ups and tests to monitor your health and how the drug is affecting your tumor. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 90 participants

Interventions

• DRUG: CGT6297 — CGT6297 Daily Oral Administration

Primary Outcomes

• Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a] (Approximately 12 months)
• Overall Response Rate [Phase 1b] (Approximately 8 months)

Secondary Outcomes

• Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1b] (Approximately 12 months)
• Pharmacokinetics (Part 1a) (Approximately 28 days)
• Pharmacokinetics (Part 1a) (Approximately 28 days)
• Pharmacokinetics (Part 1a) (Approximately 28 days)
• Pharmacokinetics (Part 1a) (Approximately 28 days)

Full Eligibility Criteria

Inclusion Criteria:

1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and/or tumor:

   1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer
   2. Phase 1b Cohort 2, participants must have HR-positive/HER2-negative or HER2-low breast cancer (immunohistochemistry \[IHC\] and in-situ hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria)
   3. Phase 1b Cohort 3 will allow all solid tumors that do not meet criteria for Phase 1b Cohorts 1 or 2, including head and neck cancers, other gynecological cancers, colorectal cancers harboring PIK3CA mutations
2. Meet prior treatment requirement of:

   1. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
   2. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition
3. Have at least one measurable lesion according to RECIST v1.1.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
6. Resolution of acute toxicities from prior anticancer therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities (other than parameters specified in screening testing as outlined below), as determined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) v5.0.
7. Have an ejection fraction ≥50%

Exclusion Criteria:

1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
3. Treatment with radiotherapy ≤2 weeks before the first dose of study drug.
4. Clinically significant cardiac disease
5. Ongoing or planned long-term (≥4 consecutive weeks) treatment with glucocorticoid steroids at greater than physiologic dosing (defined as equivalent to \>20 mg/day prednisone)
6. Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg/dL and HbA1c ≥7.0%; antihyperglycemic medical management permitted with the exception of insulin)
7. Previous molecular testing (NGS or PCR) showed tumor with the following mutations: mutations/deletions in PTEN or activating mutations in AKT, HRAS/KRAS/NRAS, EGFR, and BRAF

Trial Locations

• NEXT Austin, Austin, Texas, United States
• NEXT Virginia, Fairfax, Virginia, United States

Frequently Asked Questions

Related Conditions

• Solid Tumors
• PIK3CA Mutations
• Endometrial Cancer
• Breast Cancer
• Head and Neck Cancers
• Colorectal Cancer
• Gynecological Cancers
• Oncology
• Targeted Therapy
• Precision Medicine

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