Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZL-1211 · 1 trial · 1 indication
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of ZL-1211
Incidence of Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Objective response rate defined as the proportion of patients with partial response (PR) proportion of patients with partial response (PR) or complete response (CR) based on Investigator assessment of tumor lesions per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
| Arm | Type | Description |
|---|---|---|
| ZL-1211 monotherapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ZL-1211 | DRUG | Phase 1 dose escalation part will enroll about 12-42 patients, Phase 2 dose expansion part will enroll about 15-40 patients in each cohort |
Inclusion Criteria: Patients are eligible to be included in the study only if all the following inclusion criteria apply: 1. Adults≥ 18 years of age. 2. Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ZL-1211 is an investigational small molecule developed by Zai Lab Limited for advanced solid tumors. It is designed to bind Claudin18.2, a protein expressed on certain cancer cells. ZL-1211 has completed a Phase 1 study and is not approved for any indication.
ZL-1211 targets Claudin18.2, a tight junction protein that is expressed in a range of solid tumors. By binding Claudin18.2, the drug is intended to act on cancer cells that carry this marker. The Phase 1 study enrolled only biomarker-selected patients.
Zai Lab Limited, which trades on Nasdaq under the ticker ZLAB, is developing ZL-1211. The company sponsored the Phase 1 study of the drug in patients with advanced solid tumors.
ZL-1211 is in Phase 1 development. Its single clinical trial, NCT05065710, has been completed. The drug is investigational and has not been approved by the FDA for any indication.
ZL-1211 has been studied in one clinical trial, NCT05065710, titled A Study of ZL-1211 in Patients With Advanced Solid Tumor. The Phase 1 trial enrolled 34 patients across the United States and China and is now completed.