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Also known as ZL-2306 (niraparib)
ZL-2306 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ZL-2306 (niraparib) | EXPERIMENTAL | Subjects will be randomised into 100mg, 200mg, 300mg dose group at the first day of the first cycle. |
| Name | Type | Description |
|---|---|---|
| ZL-2306 (niraparib) | DRUG | About 30 subjects will be enrolled to the study, and randomised into 300mg, 200mg and 100mg dose groups (about 10 subjects per group). All subjects will be randomised into indicated dose group (300mg, 200mg or 100mg) at the first day of the first cycle. A single administration of ZL-2306 (niraparib) will be given to the subjects at indicated dose. |
Inclusion Criteria: 1. Signed informed consent . 2. Female, age ≥ 18 years. 3. Histologically confirmed diagnosis of FIGO stage III or IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 4. Has received no further than second-line platinum-based chemotherapy, and has clinical co...
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ZL-2306 is being studied for the treatment of ovarian cancer. It is an investigational small molecule developed by Zai Lab Limited. The clinical program has focused on evaluating its pharmacokinetics, safety, and tolerability in patients with ovarian cancer, specifically in a Phase 1 trial conducted in China.
ZL-2306 targets PARP1 and PARP2, which are enzymes involved in DNA repair. By inhibiting these targets, the drug is designed to interfere with the repair of damaged DNA in cancer cells. This mechanism is being explored in the context of ovarian cancer.
ZL-2306 is being developed by Zai Lab Limited, a biopharmaceutical company traded on the Nasdaq under the ticker symbol ZLAB. Zai Lab is responsible for the clinical development of this investigational therapy for ovarian cancer.
ZL-2306 is in Phase 1 clinical development. The completed Phase 1 trial evaluated the pharmacokinetics, safety, and tolerability of the drug in patients with ovarian cancer. It has not been approved by the FDA or any regulatory agency for commercial use.
ZL-2306 has been evaluated in a Phase 1 clinical trial identified as NCT03551171. This trial, titled "The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer," was completed and enrolled 42 female patients aged 18 years and older in China.
Yes, ZL-2306 is also known as niraparib. Zai Lab Limited is developing ZL-2306, which is a small molecule inhibitor of PARP1 and PARP2, for ovarian cancer. The alternative name niraparib is used interchangeably in the context of this investigational therapy.