ZL-1310 for Cancer

Recruiting at 8 trial locations

Overseen By ZaiLab_1310-002_StudyTeam

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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

Must not be taking: ADC topoisomerase inhibitors

Disqualifiers: CNS metastases, Cardiac disease, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 24 months

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ZL-1310, to determine its effectiveness in treating certain advanced solid tumors. Researchers aim to assess the safety and efficacy of ZL-1310 when used alone in individuals whose cancer has progressed after other treatments. The trial seeks participants with advanced cancer who have previously undergone platinum-based therapy and have measurable tumors. Participants should be in good general health and willing to provide a tumor sample for the study. As a Phase 1 trial, the research focuses on understanding how the treatment 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 taking any systemic anti-cancer treatments or investigational products at least 3 weeks before starting the study treatment. Also, you must not be on strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that ZL-1310 is likely to be safe for humans?

Research shows that ZL-1310 is generally safe for people. This treatment, which combines an antibody with a drug to target cancer cells, has a good safety record, meaning most patients experience manageable side effects.

In earlier studies with patients who had small cell lung cancer, ZL-1310 demonstrated a promising safety profile. Patients did not report severe side effects, and the treatment showed potential in fighting tumors.

Since ZL-1310 is in the early testing phase, researchers are primarily focused on ensuring its safety for a broader population. This phase also helps them understand how well people can tolerate the treatment.

Overall, while more testing is needed for confirmation, initial findings suggest ZL-1310 is safe for use in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ZL-1310 because it offers a novel approach to cancer treatment by acting as a single-agent therapy. Unlike traditional chemotherapy, which often targets rapidly dividing cells broadly, ZL-1310 is designed to specifically target cancer cells, potentially reducing damage to healthy cells and minimizing side effects. Additionally, if ZL-1310 has a unique mechanism of action, it could provide new hope for patients who haven't responded well to existing treatments. This specificity and potential for fewer side effects make ZL-1310 a promising candidate in the fight against cancer.

What evidence suggests that ZL-1310 might be an effective treatment for cancer?

Studies have shown that ZL-1310 is promising in treating certain cancers. In earlier research on patients with advanced small cell lung cancer, 68% of patients responded well, with many experiencing tumor shrinkage. Additionally, 89% of patients had some reduction in tumor size. The treatment was generally safe, with few unwanted side effects. These results suggest that ZL-1310 could be an effective option for people with certain solid tumors. Participants in this trial will receive ZL-1310 as a single agent to further evaluate its effectiveness and safety. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people with certain advanced or spreading solid tumors, including uterine tumors, who've already tried platinum-based therapy without success. They must be able to provide a tumor sample and have a life expectancy of at least 3 months. Participants should be relatively active and self-sufficient (ECOG status 0 or 1).

Inclusion Criteria

I have signed a document agreeing to participate.

I have a tumor that can be measured by standard criteria.

My cancer is advanced or has spread, and it got worse after platinum-based treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ZL-1310 as a single agent in selected solid tumors

up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ZL-1310

Trial Overview The study is testing ZL-1310's effectiveness on selected solid tumors in an early-phase trial. It's open-label, meaning everyone knows what treatment they're getting, and it involves multiple centers where the drug will be given.

How Is the Trial Designed?

Group I: Single Arm 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+

Citations

1. ir.zailaboratory.com ir.zailaboratory.com/news-releases/news-release-details/zai-lab-announces-updated-phase-1-data-zocilurtatug-pelitecan

Zai Lab Announces Updated Phase 1 Data for Zocilurtatug ... Robust responses observed in heavily pre-treated patients with a 68% ORR for 1.6 mg/kg in second-line setting.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3041

ZL-1310, a DLL3 ADC, in patients with extensive stage ... Conclusions: ZL-1310 demonstrated a tolerable safety profile and promising antitumor activity in r/r ES-SCLC, including pts with brain ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07218146

NCT07218146 | A Study of ZL-1310 Versus Investigator's ... The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with ...

4. cancernetwork.com cancernetwork.com/view/zl-1310-shows-promising-activity-in-pretreated-r-r-es-sclc

ZL-1310 Shows Promising Activity in Pretreated R/R ES- ... Data from a phase 1 trial showed an ORR of 68% and a DCR of 93% with ZL-1310 in those with extensive-stage small cell lung cancer during dose escalation.

5. ir.zailaboratory.com ir.zailaboratory.com/news-releases/news-release-details/zai-lab-presents-positive-phase-1-data-zl-1310-dll3-targeted-adc

Zai Lab Presents Positive Phase 1 Data for ZL-1310, a ... Eighty-nine percent of patients experienced a reduction in their tumor burden. Of the 31 patients with stable disease, 27 (87%) remain on study.

6. ir.zailaboratory.com ir.zailaboratory.com/news-releases/news-release-details/zl-1310-investigational-dll3-targeted-antibody-drug-conjugate

ZL-1310, an Investigational DLL3-Targeted Antibody-Drug ... This next-generation ADC therapy has the potential to deliver anti-tumor responses in the majority of patients with ES-SCLC, with good tolerability.

7. aacr.org aacr.org/about-the-aacr/newsroom/news-releases/investigational-antibody-drug-conjugate-shows-clinical-benefit-against-previously-treated-small-cell-lung-cancer/

Investigational Antibody-drug Conjugate Shows Clinical ... BOSTON – Zocilurtatug pelitecan (zoci), also known as ZL-1310, an investigational antibody-drug conjugate (ADC) that targets the protein ...