Zelenectide Pevedotin for Non-Small Cell Lung Cancer

Recruiting at 12 trial locations

Overseen By BicycleTx Limited

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BicycleTx Limited

Must not be taking: MMAE, Steroids, CYP3A inhibitors, others

Disqualifiers: SCLC, CNS metastases, Diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 3 years

73 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, zelenectide pevedotin, for individuals with non-small cell lung cancer (NSCLC) that has advanced or spread and involves a specific gene change called NECTIN4 amplification. Researchers aim to assess the treatment's effectiveness and safety for two types of NSCLC: non-squamous and squamous. It suits individuals who have already tried at least one other treatment for their advanced NSCLC and can confirm the presence of the NECTIN4 gene change. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking any systemic anticancer therapy at least 28 days before starting the study treatment. Additionally, you cannot take strong inhibitors or inducers of certain liver enzymes or P-glycoprotein while on the study.

Is there any evidence suggesting that zelenectide pevedotin is likely to be safe for humans?

Research has shown that zelenectide pevedotin is generally safe in earlier studies with patients who have advanced solid tumors. Most patients experienced at least one side effect, an unwanted reaction. However, these side effects typically did not require stopping treatment for most individuals. The treatment also demonstrated promising effects against tumors, indicating potential benefits. While some patients reported side effects, they were generally manageable. ^{1 2 3 4 5}

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

Researchers are excited about Zelenectide Pevedotin for non-small cell lung cancer (NSCLC) because it offers a novel approach compared to standard treatments like chemotherapy and targeted therapies. Zelenectide Pevedotin is unique as it combines a new active ingredient with a targeted delivery system that directly attacks cancer cells, potentially minimizing damage to healthy cells. This targeted action not only promises greater effectiveness but also may reduce side effects, making it a promising alternative for patients with both non-squamous and squamous NSCLC.

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

Research has shown that zelenectide pevedotin may help treat certain cancers. In one study, about 24% of patients with advanced solid tumors experienced significant tumor shrinkage. Another study found that when combined with another treatment, 40% of patients responded positively. This trial will evaluate zelenectide pevedotin specifically for non-small cell lung cancer, dividing participants into two cohorts: Cohort A for non-squamous NSCLC and Cohort B for squamous NSCLC. While these results are encouraging, further research is needed to confirm its effectiveness specifically for non-small cell lung cancer. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for people with advanced or metastatic non-small cell lung cancer (NSCLC) who have tried at least one therapy before. It's split into two groups: those with squamous NSCLC and those without. Participants need confirmed NECTIN4 gene amplification, can't have had more than three prior therapies, and must meet certain treatment history criteria based on their genetic alterations.

Inclusion Criteria

My lung cancer is confirmed to be of the squamous type.

My lung cancer is non-squamous and confirmed by lab tests.

My cancer can be measured by standard health scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zelenectide pevedotin for the treatment of NECTIN4-amplified advanced or metastatic NSCLC

Up to approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Zelenectide Pevedotin

Trial Overview The study is testing Zelenectide pevedotin (BT8009), a new drug for NSCLC in patients who've already undergone other treatments. There are two patient groups based on the type of NSCLC they have, and researchers want to see how effective and safe this medication is for them.

How Is the Trial Designed?

Group I: Cohort B (squamous NSCLC) Experimental Treatment 1 Intervention

Group II: Cohort A (non-squamous NSCLC) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

BicycleTx Limited

Lead Sponsor

Trials

5

Recruited

1,800+

Citations

1. investors.bicycletherapeutics.com investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-announces-data-updates-across-zelenectide

Press Release Topline combination data for zelenectide pevedotin plus pembrolizumab in first-line metastatic urothelial cancer demonstrated a 60% overall response rate, in ...

2. targetedonc.com targetedonc.com/view/zelenectide-pevedotin-shows-safety-preliminary-efficacy-in-advanced-solid-tumors

Zelenectide Pevedotin Shows Safety, Preliminary Efficacy ... Key efficacy results in the efficacy-evaluable population (n=42) showed an overall objective response rate (ORR) of 24% and a clinical benefit ...

3. jto.org jto.org/article/S1556-0864(25)00291-6/fulltext

96P: Enhanced anti-tumor activity of zelenectide pevedotin ... Of these, 2 achieved a confirmed PR with an ORR of 40.0% (5.3, 85.3), and the remaining 3 had stable disease (disease control rate 100.0%). Of the NECTIN4 non- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06933329

Study Details | NCT06933329 | Zelenectide Pevedotin in ... This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated ...

5. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO-25-00559

First-in-Human, Phase I/II Dose Escalation and Expansion ... Zelenectide pevedotin monotherapy demonstrated a generally well-tolerated safety profile and preliminary efficacy, particularly in UC, ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00559

First-in-Human, Phase I/II Dose Escalation and Expansion ... Safety data were pooled across all doses. All 49 patients treated with zelenectide pevedotin experienced at least one AE, and 46 patients (94%) ...