What side effects are associated with this type of intervention?

Common treatments for lung cancer, particularly those targeting specific mutations like KRAS G12C, often have side effects including skin reactions (e.g., rashes), gastrointestinal issues (e.g., diarrhea), and immune-related adverse events (e.g., pneumonitis, pruritus). Gefitinib, for instance, is known for mild and reversible skin and gastrointestinal disorders, while pembrolizumab and durvalumab can cause more severe reactions such as pneumonia and rash. These side effects are important considerations when evaluating treatment options.

What prior FDA approvals exist?

For the treatment of lung cancer, particularly targeting the KRAS G12C mutation, the FDA has approved sotorasib and adagrasib. These drugs are specifically designed to inhibit the KRAS G12C mutation, similar to the investigational drug HBI-2438. Additionally, other targeted therapies for different mutations in lung cancer include EGFR inhibitors like gefitinib, MET inhibitors like capmatinib, and RET inhibitors like selpercatinib and pralsetinib.

What other types of research exist?

Promising novel alternatives to HBI-2438 for lung cancer patients include WB-308, a novel EGFR-TKI that may substitute for Gefitinib in clinical therapy for NSCLC. Additionally, other targeted therapies and immunotherapies under investigation, such as pembrolizumab plus cetuximab, may offer potential treatment options.

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Epigenetic Modulator

HBI-2438 for Cancer with KRAS G12C Mutation

Phase 1

Recruiting

Led By Alberto Bessudo, MD

Research Sponsored by HUYABIO International, LLC.

Eligibility Criteria Checklist

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

Must have

Male or female at least 18 years of age at the time of signing the ICF prior to initiation of any study specific activities/procedures

Advanced malignant solid tumors with KRAS G12C mutation- as determined by genetic testing

Must not have

Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first dose of HBI-2438; or the presence of unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher

Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, except alopecia, within 4 weeks of first study treatment administration

Timeline

Screening 28 days

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests HBI-2438, an oral drug for patients with advanced solid tumors having the KRAS G12C mutation. The drug aims to stop cancer growth by blocking the faulty gene. Related drugs, Adagrasib and Sotorasib, have shown effectiveness in treating similar conditions.

Who is the study for?

This trial is for adults with advanced solid tumors that have a specific genetic change called KRAS G12C mutation. They should be able to swallow pills, have at least one measurable tumor, and good organ function. They must not benefit from standard treatments and should not have serious heart issues or unresolved severe side effects from past cancer therapy.

What is being tested?

The study tests different doses of HBI-2438 in patients to find the highest dose they can take without too many side effects (maximum tolerated dose) and to see how the body processes the drug (pharmacokinetic profile).

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on determining safe dosage levels, specific side effects of HBI-2438 are not listed but may include typical reactions seen with other cancer drugs such as nausea, fatigue, liver toxicity, and risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer has a KRAS G12C mutation.

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I am fully active or can carry out light work.

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I can swallow pills and don't have major stomach or intestine issues.

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My cancer has a KRAS G12c mutation.

Exclusion Criteria

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

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I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.

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I don't have any major side effects from cancer treatment, except for hair loss.

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I have not been treated with KRAS G12C inhibitors before.

Timeline

Screening ~ 28 days2 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 28 days

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 28 days for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the maximum tolerated dose (MTD)

adverse events (AEs), and serious adverse events (SAEs) overall

Secondary study objectives

Area Under the Curve (AUC)

Pharmacokinetic variables including clearance

Pharmacokinetic variables including serum half-life

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

HBI-2438 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6-8 patients will then be enrolled in the expansion cohort at the recommended dose.

0 / 8Eligibility 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

Lung cancer treatments often target specific genetic mutations or pathways involved in tumor growth. For instance, KRAS G12C inhibitors, like the investigational drug HBI-2438, specifically target the KRAS G12C mutation, which is a common driver in non-small cell lung cancer (NSCLC). These inhibitors work by irreversibly binding to the mutant KRAS protein, thereby inhibiting its activity and preventing tumor growth. This targeted approach is crucial as it offers a more personalized treatment, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy. Other common treatments include EGFR inhibitors for EGFR-mutant NSCLC and ALK inhibitors for ALK-rearranged NSCLC, which similarly target specific genetic alterations. Immunotherapies, such as PD-1/PD-L1 inhibitors, enhance the body's immune response against cancer cells. Understanding these mechanisms helps in selecting the most effective treatment based on the tumor's genetic profile, thereby improving patient prognosis and quality of life.

New systemic strategies for overcoming resistance to targeted therapies in non-small cell lung cancer.Tailoring tyrosine kinase inhibitors to fit the lung cancer genome.