180 Participants Needed

ZL-6201 for Cancer

ZS
Overseen ByZL-6201-001 Study Team
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Zai Lab (Shanghai) Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ZL-6201, to determine its safety and tolerability. The focus is on treating sarcoma and other solid tumors, which are challenging cancer types. Suitable candidates have been diagnosed with locally advanced or metastatic sarcoma or certain solid tumors and have already tried a few treatments. If you have had sarcoma or a solid tumor but have not undergone more than two or three previous therapies, this trial might be suitable for you. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering the opportunity to be among the first to receive this new drug.

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

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have had recent systemic anti-cancer treatment within the last 3 weeks.

Is there any evidence suggesting that ZL-6201 is likely to be safe for humans?

Research shows that ZL-6201 is a promising new cancer treatment. It targets a protein linked to cancer cells, aiming to disrupt their growth. However, since ZL-6201 is in the early testing phase (Phase 1), detailed safety information for humans is not yet available. This phase typically involves testing the treatment in people for the first time to assess safety and tolerance.

So far, initial trials have reported no serious side effects. However, these studies are ongoing, and more information will clarify ZL-6201's safety. Those considering joining a trial should remember that new treatments may have unknown risks. Always consult a doctor to weigh potential benefits and risks.12345

Why do researchers think this study treatment might be promising?

ZL-6201 is unique because it represents a new approach in cancer treatment, working as a single-agent therapy. While many current cancer treatments, like chemotherapy, aim to kill rapidly dividing cells, ZL-6201 targets specific pathways within cancer cells, potentially leading to fewer side effects and more precise action. Researchers are particularly excited about its novel mechanism of action, which could offer a more targeted treatment option compared to the broad-based approaches of traditional therapies. This specificity might improve patient outcomes by attacking cancer cells more effectively while sparing healthy cells.

What evidence suggests that ZL-6201 might be an effective treatment for cancer?

Research has shown that ZL-6201 is a new drug combining an antibody with a cancer-fighting agent. It targets a protein called LRRC15, often found in cancer cells. The drug is designed to attach to LRRC15, delivering treatment directly to the cancer cells. Early results suggest that ZL-6201 may shrink or slow the growth of sarcoma and other solid tumors, potentially leading to new treatment methods for these cancers. Although more research is needed to confirm its effectiveness, the targeted approach of ZL-6201 appears promising.16789

Are You a Good Fit for This Trial?

Adults over 18 with certain types of advanced sarcoma or solid tumors can join this trial. They should be relatively healthy (ECOG status 0 or 1), have a life expectancy over three months, and have received limited prior treatments (no more than 3 for solid tumors, no more than 2 for sarcomas). Participants need measurable cancer lesions, good organ function, and must not have HIV/HBV/HCV. A biopsy is required before treatment starts.

Inclusion Criteria

I've had 3 or fewer treatments for my cancer after it spread or didn't respond to treatment.
I do not have HIV, hepatitis B, or hepatitis C.
I am over 18, can care for myself with minimal help, and expected to live more than 3 months.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ZL-6201 as a single agent in 21-day cycles to evaluate safety, tolerability, and preliminary efficacy

36 months
Visits every 21 days for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ZL-6201

Trial Overview

The study tests ZL-6201's safety and how well it works in treating sarcoma and other solid tumor cancers. It's an early-phase trial to see how patients tolerate the drug and to observe any preliminary signs of its effectiveness against these cancers.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ZL-6201Experimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Zai Lab Presents Data Highlighting Potential of Internally ...

ZL-6201 is a potential first- and best-in-class ADC with high affinity and specificity for LRRC15, an appealing target for cancer therapy due to ...

Discovery and characterization of a novel LRRC15-targeting ...

ZL-6201 is an innovative antibody-drug conjugate (ADC) targeting LRRC15, developed using the TME-activable linker-payload (TMALIN®) platform.

Zai Lab's ZL-6201 Study Advances in Sarcoma and Solid ...

It also looks for early signs that the drug may help shrink or slow these tumors, which could open a new path in solid tumor treatment. The ...

ZL-6201 - Drug Targets, Indications, Patents

An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants With ...

Zai Lab Announces Third Quarter 2025 Financial Results and ...

Zai Lab to provide the initial data readout from the global Phase 1/1b study in healthy volunteers and participants with moderate to severe ...

NCT07374848 | Phase 1a/b Study of ZL-6201 Safety, PK, ...

The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.

Zai Lab Highlights Strategic Priorities and Global Pipeline ...

ZL-6201: A novel LRRC15-targeting ADC designed to disrupt the tumor microenvironment by targeting tumor-associated fibroblasts (TAF), enabling ...

ZL-6201 / ZAI Lab

Expected Clinical Developments and Data Readouts:…ZL-6201 ... Delicious. March 26, 2025. Zai Lab to Present New Data from Internally Developed, Next-Generation ...

Zai Lab to Present New Data from Internally Developed, ...

Zai Lab is evaluating ZL-6201 as a potential first-in-class LRRC15 ADC targeting multiple solid tumors. Interleukin-12 treatments have ...