What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like cisplatin and docetaxel can cause nausea, vomiting, fatigue, hair loss, and increased infection risk. Targeted therapies, such as EGFR Tyrosine Kinase Inhibitors (TKIs) like erlotinib and gefitinib, often lead to rash, diarrhea, and liver function abnormalities. Immunotherapy agents, such as pembrolizumab, can cause immune-related adverse events like colitis, pneumonitis, and thyroid dysfunction. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include a variety of targeted therapies and immunotherapies. For NSCLC with EGFR mutations, drugs like osimertinib, erlotinib, and gefitinib have been approved. Immunotherapies such as pembrolizumab and atezolizumab, often in combination with chemotherapy, have also received FDA approval for broader NSCLC indications. These treatments aim to improve overall survival and progression-free survival in patients with advanced or metastatic NSCLC.

What other types of research exist?

Promising novel alternatives to BBT-207 for NSCLC patients in 2024 include: 1) Amivantamab, a bispecific antibody targeting EGFR and MET, showing efficacy in EGFR-mutant NSCLC. 2) Mobocertinib, an oral EGFR inhibitor specifically targeting EGFR exon 20 insertion mutations. 3) Lazertinib, a third-generation EGFR-TKI with promising results in combination with amivantamab. 4) KRAS G12C inhibitors like Sotorasib and Adagrasib, targeting a common mutation in NSCLC. These agents represent significant advancements in targeted therapy for NSCLC.

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BBT-207 for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Bridge Biotherapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed Stage III (locally advanced) NSCLC not amenable to curative therapy or stage IV NSCLC

Patients must have received treatment with at least 1 third-generation EGFR TKI (eg, Osimertinib, Lazertinib)

Must not have

Clinically significant, uncontrolled, cardiovascular disease including congestive heart failure grade 3 or 4 according to the New York Heart Association classification; myocardial infarction or unstable angina, uncontrolled hypertension, or clinically significant, uncontrolled arrhythmias, including bradyarrhythmia that may cause QT prolongation within the last 6 months from the first dose of study treatment

An EGFR TKI within 8 days of the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BBT-207 to see if it is safe and effective for treating cancer. It will involve cancer patients to determine how the drug behaves in the body and its impact on tumors. The study will be conducted over time to find the best dose and evaluate its effectiveness.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific EGFR mutation and has worsened after treatment with EGFR TKI therapy. Participants should have tried all standard treatments, be in relatively good physical condition (ECOG score of 0 or 1), and have tumors that responded at some point to previous EGFR TKI treatment. People can't join if they have unresolved side effects from past therapies, certain heart conditions, recent radiotherapy, or took other cancer drugs too close to the start of this study.

What is being tested?

BBT-207 is being tested in patients with NSCLC who no longer respond to standard treatments. The study includes dose escalation to find a safe amount, selection of an optimal Phase 2 dose, and then expansion where more people are given this chosen dose. It's open label so everyone knows they're getting BBT-207.

What are the potential side effects?

While the exact side effects of BBT-207 aren't listed here since it's a first-in-human study, common ones for new cancer drugs may include nausea, fatigue, skin reactions, diarrhea or constipation. Organ inflammation and blood count changes could also occur.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is at an advanced stage and cannot be cured with surgery.

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I have been treated with a specific lung cancer medication like Osimertinib.

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I am fully active or can carry out light work.

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My cancer didn't grow for at least 4 months after starting treatment with an EGFR inhibitor.

Exclusion Criteria

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

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I do not have serious heart problems or uncontrolled high blood pressure.

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I have taken an EGFR inhibitor within the last 8 days.

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My heart's electrical activity (QT interval) is longer than normal.

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I've had fainting, fast heart rate, or sudden heart issues in the past 6 months.

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I haven't taken certain cancer drugs within the last 14 or 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 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

[Phase 1a dose escalation] Determine Recommended Dose Range

[Phase 1a dose escalation] Incidence of Treatment-Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and ≥grade 3 laboratory abnormalities.

[Phase 1b Recommended Phase 2 Dose selection] Determine the RP2D

+1 more

Secondary study objectives

[Phase1b, Phase2] Incidence of Treatment-Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, and ≥grade 3 laboratory abnormalities.

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: Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutationExperimental Treatment1 Intervention

Group II: Phase 1b; At 2 recommended dose levels of BBT-207 in patients with EGFR C797S mutationExperimental Treatment1 Intervention

Group III: Phase 1a; Dose escalation at various dose levels in patients with EGFR TKI sensitizing mutationExperimental Treatment1 Intervention

0 / 9Eligibility 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 treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as EGFR inhibitors, block specific proteins that drive cancer cell growth, making them particularly effective for patients with certain genetic mutations. Immunotherapies, like PD-1/PD-L1 inhibitors, boost the immune system's ability to detect and kill cancer cells. These treatments are significant for NSCLC patients as they provide more personalized and potentially more effective options compared to traditional chemotherapy, especially for those with specific genetic profiles or protein expressions.