ZL-1310 for Small Cell Lung Cancer

Recruiting at 34 trial locations

Overseen By Yun Wang

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

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

Disqualifiers: Other malignancy, Brain metastasis, others

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

Compensation: Varies

Number of Visits: Unknown

112 Participants Needed

Trial Summary

What is the purpose of this trial?

An Open-label, Multicenter Study of ZL-1310 as a Single Agent and In Combination with Atezolizumab to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic anti-cancer treatments or investigational products at least 3 weeks before starting the study treatment. Additionally, you must not be on strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first study treatment. If you are on chronic systemic steroid therapy or immunosuppressive therapy, you must stop these 14 days or 5 half-lives before the study treatment, whichever is longer.

Eligibility Criteria

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.

Inclusion Criteria

I have a tumor that can be measured by scans.

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

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

Exclusion Criteria

I haven't had cancer treatment or been part of a trial in the last 3 weeks.

My cancer has spread to the lining of my brain and spinal cord.

I have no other cancers needing treatment in the last 2 years, except for minor skin cancers or in situ cervical cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ZL-1310 as a single agent or in combination with Atezolizumab and Carboplatin to determine the maximum tolerated dose

up to 24 months

Dose Expansion

Participants receive the established dose level of ZL-1310 to further evaluate safety and efficacy

up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ZL-1310

Trial Overview 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.

Participant Groups

Group I: Dose Extension: Arm 1 Experimental Treatment 1 Intervention

ZL-1310 as a single agent

Group II: Dose Expansion: Arm 2 Experimental Treatment 1 Intervention

Dose level 2 of ZL-1310 established from single-agent dose-escalation

Group III: Dose Expansion: Arm 1 Experimental Treatment 1 Intervention

Dose level 1 of ZL-1310 established from single-agent dose-escalation

Group IV: Dose Escalation: Arm 3 Experimental Treatment 3 Interventions

ZL-1310 in combination with Atezolizumab and Carboplatin as induction and followed by ZL-1310 and Atezolizumab as maintenance

Group V: Dose Escalation: Arm 2 Experimental Treatment 2 Interventions

ZL-1310 in combination with Atezolizumab

Group VI: Dose Escalation: Arm 1 Experimental Treatment 1 Intervention

ZL-1310 as a single-agent

Who Is Running the Clinical Trial?

Zai Lab (Shanghai) Co., Ltd.

Lead Sponsor

Trials

30

Recruited

3,800+

Zai Lab (US) LLC

Industry Sponsor

Trials

3

Recruited

450+