A Study of NBL-028 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovaRock Biotherapeutics, Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥18 years old, should have fully understood the study and voluntarily signed an informed consent form.
Patients with pathologically diagnosed advanced solid tumors with positive expression of CLDN6. Stage I: Patients have failed or cannot tolerate standard of care, or without standard treatment; Stage Ⅱ: Previously treated advanced solid tumors.
Be able to provide previously well-preserved tumor tissue sections, or agree to undergo tumor tissue biopsy for central laboratory biomarker testing.
At least one measurable target lesion according to RECIST 1.1.
Disqualifiers
Previously received CLDN6-targeted or CD137-targeted treatment.
Known uncontrolled central nervous system (CNS) cancer including CNS metastasis, meningeal metastasis, or spinal cord compression.
Patients with high risk of bleeding due to tumor invasion of important arteries.
Has uncontrolled serous cavity effusion (such as pleural effusion, abdominal effusion, or pericardial effusion, etc) requiring repeated drainage.
Trial design
Design model
Single group
Treatments tested in this trial
NBL-028
DrugIntravenous infusion (IV), once every two weeks (one treatment cycle is 4 weeks).
Treatment groups
270 Participants
are divided into 1 treatment groupGroup A: NBL-028Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity（DLT）
Dose-limiting toxicity
Time frame
Up to approximately 1 years2
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)
Time frame
Up to approximately 3 years3
Maximum Tolerated Dose（MTD） of NBL-028
Maximum Tolerated Dose
Time frame
Up to approximately 1 years4
Recommended Phase 2 dose（RP2D）
Recommended Phase 2 dose
Time frame
Up to approximately 1 yearsSecondary outcomes
1
Overall response rate (ORR).Determined using RECIST v1.1 criteria.
Objective response rate
Time frame
Up to approximately 3 years2
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Cmax.
Observed maximum concentration
Time frame
Up to approximately 3 years3
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Area under curve（AUC）.
AUC0-t
Time frame
Up to approximately 3 years4
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Tmax.
Time to maximum concentration
Time frame
Up to approximately 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov