ZL-1211 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Zai Biopharmaceutical (Suzhou) Co., Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is a Phase I/II, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of ZL-1211 administered by IV infusion on a every 2 weeks (Q2W) schedule.

Eligibility Criteria

Adults over 18 with advanced solid tumors that standard treatments can't help may join this trial. They must have measurable disease, be in good physical condition (ECOG 0 or 1), and have normal organ function. Only those with CLDN18.2-positive tumors are eligible after tissue testing.

Inclusion Criteria

My tumor is CLDN18.2 positive.

My blood counts are within the required ranges and I've recovered from previous cancer treatment side effects.

I am fully active or have some restrictions but can still care for myself.

My advanced cancer is not responding to standard treatments.

My kidney function is within the normal range.

Exclusion Criteria

I have a lung condition like COPD or pulmonary fibrosis that causes symptoms.

I haven't had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.

I do not have current severe stomach or bowel problems.

I have never received CLDN18.2 antibody or CAR T cell therapy.

I haven't had cancer treatment or radiation within the last 4 weeks or less.

I do not have severe heart disease or recent serious heart rhythm problems.

I do not have HIV/AIDS or active/chronic hepatitis B or C.

I do not have any ongoing infections that aren't being treated.

Participant Groups

ZL-1211 is being tested for safety and effectiveness against solid tumors. This early-phase study involves increasing doses to find the right amount and then expanding to more patients to learn how well it works when given every two weeks by IV infusion.

1Treatment groups

Experimental Treatment

Group I: ZL-1211 monotherapyExperimental Treatment1 Intervention