ZG006 for Small Cell Lung Cancer

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard "3+3" design will be used to assess the MTD/ recommended dose for the subsequent studies.

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.

What data supports the effectiveness of the drug ZG006 for treating small cell lung cancer?

The research highlights that small cell lung cancer (SCLC) is aggressive but responds well to chemotherapy, and recent trials with new drug combinations have shown some improvements. Although specific data on ZG006 is not provided, the general trend in SCLC treatment suggests that novel drug combinations can lead to better outcomes. ^{1 2 3 4 5}

How is the drug ZG006 different from other treatments for small cell lung cancer?

The drug ZG006 may offer a novel approach to treating small cell lung cancer by potentially combining standard regimens with newer agents, which has shown promise in doubling median survival in some cases. This suggests that ZG006 could be part of a new wave of treatments that aim to significantly increase survival with manageable side effects. ^{3 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

SCLC Treatment in the Immuno-Oncology Era: Current Evidence and Unmet Needs. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

What Is New in Small Cell Lung Cancer. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Palliative care in poor-performance status small cell lung cancer patients: is there a mandatory role for chemotherapy? [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

[Treatment of small cell lung cancer]. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Recent advances in the treatment of small cell lung cancer. [2005]

6. England pubmed.ncbi.nlm.nih.gov

Advances in systemic therapy of small cell cancer of the lung. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy with curative potential in small cell carcinoma of the lung. [2005]

8. Japan pubmed.ncbi.nlm.nih.gov

[Chemotherapy for small-cell lung cancer]. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Prolonging Survival: The Role of Immune Checkpoint Inhibitors in the Treatment of Extensive-Stage Small Cell Lung Cancer. [2023]