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Monoclonal Antibodies

Dose Escalation for Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by Zai Lab (Shanghai) Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Subjects must have histologically or cytologically confirmed metastatic or extensive-stage small cell lung cancer with documented disease progression during or following a platinum-based chemotherapy regimen. No more than 3 prior regimens in the r/r setting are allowed.

Subjects must have at least one measurable target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is studying a drug called ZL-1310 in people with small cell lung cancer. The study will look at how safe and well-tolerated the drug is, as well as how

Who is the study for?

This trial is for individuals with Small Cell Lung Cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health standards and may be required to have a particular stage of cancer.Check my eligibility

What is being tested?

The study involves ZL-1310, which is being evaluated for safety, how well it's tolerated by patients, and its pharmacokinetics (how the drug moves through the body) in those with Small Cell Lung Cancer.See study design

What are the potential side effects?

Potential side effects are not listed; however, common side effects for cancer treatments can include nausea, fatigue, hair loss, and increased risk of infection. The specific profile will depend on how ZL-1310 works.

Eligibility Criteria

Inclusion Criteria

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

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My small cell lung cancer has worsened after platinum-based treatment, and I've had no more than 3 treatments since.

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I have a tumor that can be measured by scans.

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I am 18 or older and can care for myself with minimal assistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Dose Limiting Toxicities

Incidence of Serious Adverse Events

Incidence of Treatment Emergent Adverse-Events

Secondary outcome measures

DCR per RECIST 1.1

Duration of Response per RECIST 1.1

ORR per RECIST 1.1

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion: Arm 2Experimental Treatment1 Intervention

Dose level 2 established from escalation

Group II: Dose Expansion: Arm 1Experimental Treatment1 Intervention

Dose level 1 established from escalation

Group III: Dose EscalationExperimental Treatment1 Intervention

Dose Escalation

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zai Lab (US) LLCIndustry Sponsor

1 Previous Clinical Trials

250 Total Patients Enrolled

Zai Lab (Shanghai) Co., Ltd.Lead Sponsor

28 Previous Clinical Trials

3,541 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals and purposes of this clinical investigation?

"The primary objective of this clinical trial, lasting approximately 24 months, is to evaluate the incidence of dose-limiting toxicities. Secondary objectives include assessing the Objective Response Rate (ORR) per RECIST 1.1 criteria, Overall Survival (OS), and Pharmacokinetics (PK) specifically related to unconjugated payloads."

Answered by AI

Has the FDA granted approval for dose escalation in medical treatments?

"Given that this is a Phase 1 trial, the safety rating for Dose Escalation would be relatively low at 1. Limited data is available to support both safety and efficacy at this stage of the study."

Answered by AI

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"A total of 10 clinical trial sites are currently recruiting patients, including Zai Lab Site 2013 situated in Detroit, Zai Lab Site 2018 located in Durham, and Zai Lab Site 2005 based in Duarte. Additionally, there are another ten locations where recruitment is taking place."

Answered by AI

Is the enrollment for this medical study currently accepting new participants?

"According to the latest information available on clinicaltrials.gov, this particular clinical trial is not actively enrolling patients. The initial posting date was January 31st, 2024 and it was last updated on December 19th, 2023. However, there are currently a total of 278 other ongoing clinical trials that are actively seeking participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer

2024. "An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179069.

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