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This is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion.
Dose escalation will be guided by the Bayesian optimal interval (BOIN) design including accelerated titration to determine the maximum tolerated dose (MTD) of NBL-028. Dose expansion - Additional patients (no more than 200) will be enrolled at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Sponsor may elect to enroll specific tumor types into four cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBL-028 | Experimental | Patients will be treated with NBL-028 at starting dose of 0.01 mg/kg in dose escalation stage. In dose expansion stage, patients will be treated with NBL-028 at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBL-028 | Drug | Intravenous infusion (IV), once every two weeks (one treatment cycle is 4 weeks). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity(DLT) | Dose-limiting toxicity | Up to approximately 1 years |
| Incidence and severity of adverse events (AE) and serious adverse events (SAE) Incidence, nature, and severity of adverse events will be graded according to the NCI CTCAE v5.0 | adverse events (AEs) and severe adverse events (SAEs) | Up to approximately 3 years |
| Maximum Tolerated Dose(MTD) of NBL-028 | Maximum Tolerated Dose | Up to approximately 1 years |
| Recommended Phase 2 dose(RP2D) | Recommended Phase 2 dose | Up to approximately 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR).Determined using RECIST v1.1 criteria. | Objective response rate | Up to approximately 3 years |
| Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Cmax. | Observed maximum concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu, Ph.D | Sun Yat-Sen University (SYSU) Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.896 East Zhongshan Road, Shijiazhuang, Hebei Province, China. | Recruiting | Shijiazhuang | Hebei | China |
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| Up to approximately 3 years |
| Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Area under curve(AUC). | AUC0-t | Up to approximately 3 years |
| Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Tmax. | Time to maximum concentration | Up to approximately 3 years |
| Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter t1/2. | Apparent terminal Half-Life | Up to approximately 3 years |
| anti-drug antibody(ADA) | anti-drug antibody titer | Up to approximately 3 years |
| Disease control rate(DCR) | Disease control rate | Up to approximately 3 years |
| Duration of response (DoR) | Duration of response | Up to approximately 3 years |
| Progression free survival(PFS) | Progression free survival | Up to approximately 3 years |