BBT-207 for Non-Small Cell Lung Cancer

Recruiting at 6 trial locations

Overseen By Bridge Biotherapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bridge Biotherapeutics, Inc.

Must be taking: EGFR TKIs

Must not be taking: Small molecule inhibitors

Disqualifiers: Symptomatic brain metastases, cardiac conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BBT-207 for individuals with non-small cell lung cancer (NSCLC), specifically targeting tumors with certain EGFR mutations. The study aims to determine the safety and effectiveness of BBT-207 by testing various doses and observing its impact on cancer. It is open to those with advanced NSCLC who have tried other EGFR-targeting treatments and experienced disease progression or side effects. Participants must have confirmed EGFR mutations known to respond to these treatments and have previously benefited from them but now require new options. As a Phase 1 trial, this research focuses on understanding how BBT-207 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any EGFR TKI medications, like osimertinib or afatinib, at least 8 days before starting the study treatment. Other targeted inhibitors or chemotherapy must be stopped 14 days before, and biologic anticancer medicines 28 days before starting the trial.

Is there any evidence suggesting that BBT-207 is likely to be safe for humans?

Research shows that BBT-207 has just begun testing in humans, so most safety information comes from these early studies. Before human trials, lab research indicated that BBT-207 might be effective against certain lung cancer mutations.

BBT-207 is currently in a Phase 1/2 study, where researchers primarily assess its safety and tolerability. During these early stages, they closely monitor for side effects. At this point, determining the optimal dose and observing any adverse reactions is typical.

Detailed information about BBT-207's safety in humans remains limited, but these studies aim to understand its safety profile. Since BBT-207 is still under investigation, learning about its safety continues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

Unlike the standard treatments for non-small cell lung cancer, which primarily include EGFR tyrosine kinase inhibitors (TKIs) like gefitinib, erlotinib, and osimertinib, BBT-207 is unique because it targets the EGFR C797S mutation. This mutation often arises as a resistance mechanism to current EGFR TKIs, making BBT-207 a promising option for patients who no longer respond to these standard treatments. Researchers are excited about BBT-207 because it could potentially overcome resistance to existing therapies, offering a new hope for patients with limited options.

What evidence suggests that BBT-207 might be an effective treatment for non-small cell lung cancer?

Research shows that BBT-207 is a promising new treatment for non-small cell lung cancer. In early studies, BBT-207 demonstrated a strong ability to fight tumors, with high survival rates in test groups. This trial will explore BBT-207 across different phases: Phase 1a involves dose escalation in patients with an EGFR TKI sensitizing mutation, Phase 1b tests two recommended dose levels in patients with an EGFR C797S mutation, and Phase 2 evaluates the recommended phase 2 dose in patients with an EGFR C797S mutation. This treatment targets specific changes in the EGFR gene, often linked to cancer's resistance to treatment. By focusing on these changes, BBT-207 aims to effectively stop cancer growth. Initial results suggest that BBT-207 may overcome resistance to previous treatments, offering hope for those with certain genetic changes in their cancer. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My cancer has a specific EGFR mutation (C797S).

My tumor has an EGFR mutation sensitive to treatment.

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1a involves dose escalation at various dose levels in patients with EGFR TKI sensitizing mutation to determine the recommended dose range

12 months

Recommended Phase 2 Dose Selection

Phase 1b involves selecting the recommended phase 2 dose at 2 dose levels of BBT-207 in patients with EGFR C797S mutation

12 months

Dose Expansion

Phase 2 involves dose expansion at the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation to evaluate preliminary antitumor activity

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BBT-207

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 2; At the recommended phase 2 dose of BBT-207 in patients with EGFR C797S mutation Experimental Treatment 1 Intervention

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

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

Who Is Running the Clinical Trial?

Bridge Biotherapeutics, Inc.

Lead Sponsor

Trials

10

Recruited

560+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05920135

NCT05920135 | First-in-Human Study of BBT-207 ... This is an open label, multi-center, Phase 1/2 study evaluating the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11376191/

Next-generation EGFR tyrosine kinase inhibitors to ... BDTX-1535 is a 4th-generation irreversible, brain penetrant, EGFR MasterKey inhibitor that targets EGFR resistance mutation in NSCLC and in GBM.

3. bqura.com bqura.com/posts/297

BridgeBio Therapeutics Advances Phase 1 Trial of 4th- ... The company has independently discovered BBT-207, a next-generation non-small cell lung cancer treatment candidate, and is conducting clinical ...

4. prnewswire.com prnewswire.com/news-releases/bridge-biotherapeutics-releases-updated-preclinical-data-for-bbt-207-at-the-aacr-annual-meeting-301801060.html

Bridge Biotherapeutics Releases Updated Preclinical Data ... On Day 21 of the trial, the BBT-207 low-dose group, the high-dose group, and the control group exhibited 75%, 100% and 25% of the survival rate ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0968089625000872

A clinical review on third and fourth generation EGFR ... This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs.

6. ctv.veeva.com ctv.veeva.com/study/first-in-human-study-of-bbt-207-in-advanced-non-small-cell-lung-cancer-harboring-egfr-mutation-after

First-in-Human Study of BBT-207 in Advanced Non-Small Cell ... This is an open label, multi-center, Phase 1/2 study evaluating the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207.

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/bridge-biotherapeutics-nsclc-trial/

Bridge Biotherapeutics begins trial of EGFR-mutant ... Preclinical data showed that BBT-207 demonstrated activity against treatment-emergent complex EGFR mutations. ... The trial will enrol around 92 ...

8. clin.larvol.com clin.larvol.com/trial-detail/NCT05920135

First-in-Human Study of BBT-207 in Advanced Non-Small ... The Phase 1/2 study...an open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of BBT-207 in ...