ZG006 for Small Cell Lung Cancer

Recruiting at 5 trial locations

Overseen By Zelgen

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Must not be taking: Immunosuppressants, Vaccines

Disqualifiers: Active infection, Severe allergy, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ZG006 for individuals with small cell lung cancer (SCLC) who haven't responded to standard treatments. Researchers aim to determine the optimal dose of ZG006 for future studies. Suitable candidates for this trial have small cell lung cancer that tests positive for DLL3 and a life expectancy of at least three months. As a Phase 1 trial, this research seeks to understand how ZG006 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 certain treatments before joining. You must not have had chemotherapy, biotherapy, or certain other therapies within 4 weeks, and you should not be on systemic immunosuppressive medications within 14 days before starting the trial.

Is there any evidence suggesting that ZG006 is likely to be safe for humans?

Research has shown that ZG006 has produced promising results in earlier studies. One study found that ZG006 was safe for people with small cell lung cancer who had already tried at least two other treatments. The treatment was generally well-tolerated, with manageable side effects. While this is encouraging, it's important to note that the current trial is in an early stage. This stage aims to determine the best dose and identify any side effects. Safety information from this stage will guide future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ZG006 for small cell lung cancer because it offers a new approach by potentially targeting cancer cells more precisely. Unlike traditional chemotherapy, which attacks both cancerous and healthy cells, ZG006 is designed to home in on specific cancer cell markers, possibly reducing side effects. This novel mechanism of action could lead to better outcomes and improved quality of life for patients.

What evidence suggests that ZG006 might be an effective treatment for small cell lung cancer?

Research has shown that ZG006, the investigational treatment in this trial, may help treat small cell lung cancer (SCLC), particularly in patients who have tried other treatments. In one study, 60.9% of patients receiving ZG006 experienced tumor shrinkage, indicating a reduction in tumor size for more than half of the participants. Other studies suggest that ZG006 is generally safe and well-tolerated. It has proven effective even for those who have undergone multiple treatments. Overall, the evidence suggests that ZG006 could be a promising option for people with advanced SCLC. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with small cell lung cancer who have not responded to or cannot tolerate standard treatments. Participants must have a life expectancy of at least 3 months, be relatively active and mobile (ECOG status 0-1), and agree to use reliable contraception during and for six months after the study.

Inclusion Criteria

My doctor expects me to live for at least 3 more months.

I am fully active or can carry out light work.

My small cell lung cancer has not responded to standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ZG006 in a dose escalation stage using a '3+3' design to assess the maximum tolerated dose (MTD) and recommended dose

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• ZG006

Trial Overview The trial is testing ZG006, a new potential treatment for small cell lung cancer. It's in Phase 1 where researchers are trying to find the highest dose patients can take without serious side effects using a '3+3' design to gradually increase doses among groups of participants.

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead Sponsor

Trials

70

Recruited

8,600+

Dr. Zelin Sheng

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Chief Executive Officer since 2009

PhD

Dr. Qingping Gao

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

Recent phase III studies have shown that combining immunotherapy with double platinum chemotherapy can lead to practice-changing results in treating small cell lung cancer (SCLC), which affects 13%-15% of lung cancer patients.

Despite these advancements, the overall benefit of immunotherapy remains modest, and most patients still face disease recurrence, highlighting the need for better predictive factors and innovative treatment strategies to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SCLC Treatment in the Immuno-Oncology Era: Current Evidence and Unmet Needs. Belluomini, L., Calvetti, L., Inno, A., et al.[2022]

Small cell lung cancer (SCLC) is a rare and aggressive form of lung cancer, making up 15% of all lung cancer cases, with a very poor prognosis of about 1 year.

The article reviews various strategies to improve outcomes for SCLC, including trials of new immunotherapy agents, targeting novel disease mechanisms, and exploring multiple drug combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is New in Small Cell Lung Cancer. Matera, R., Chiang, A.[2023]

Small cell lung cancer responds well to combination chemotherapy and radiotherapy, which are effective in targeting its rapid cell division.

Despite improvements in treatment regimens leading to better response rates, long-term survival rates for patients have not significantly improved in the last decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the treatment of small cell lung cancer. Hosker, HS., Veale, D., Corris, PA.[2005]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8007

A phase 2 dose expansion study of ZG006, a trispecific T ... Conclusions: ZG006 exhibited promising efficacy and acceptable safety in SCLC pts receiving ≥2 lines of prior treatment, even in pts with low ...

2. asco.org asco.org/abstracts-presentations/ABSTRACT484276

A phase 1 dose escalation and expansion study of ZG006 ... Twenty-three SCLC patients receiving ZG006 10-60 mg were efficacy-evaluable with at least one post-baseline tumor assessment, and the ORR was 60.9% (14/23, 10 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07038096

ZG006 and ZG005 in Participants With Small Cell Lung ... This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ...

4. conference-correspondent.com conference-correspondent.com/highlights/asco/asco-2025-small-cell-lung-cancer/promising-phase-2-results-for-zg006-a-trispecific-t-cell-engager-in-advanced-small-cell-lung-cancer

Promising Phase 2 Results for ZG006, a Trispecific T-Cell ... ZG006 demonstrated promising efficacy and an acceptable safety profile among patients with SCLC who were heavily pretreated. The ongoing phase 2 study continues ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02271-3/fulltext

686TiP Preliminary phase I results from a first-in-human ... Preclinical pharmacological and toxicological studies have demonstrated that ZG006 exhibits promising anti-tumor activity and favorable safety profiles both in ...

6. trials.braintumor.org trials.braintumor.org/trials/NCT05978284

Study of ZG006 in Participants With Small Cell Lung Cancer or ... This is a multi-center, open-label, Phase Ⅰ/Ⅱ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma ...