A Study of the ILB-3101 in Patients with Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInnolake Biopharm
About this trial
ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have signed informed consent forms voluntarily.
18-80 years old.
Having an ECOG performance status score of 0 or 1.
With an expected survival of more than 12 weeks.
Disqualifiers
Received urea nitrite or mitomycin C within 6 weeks prior to the first use of the study drug.
Oral administration of fluorouracil or small molecule targeted drugs within 2 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is longer).
Individuals who have received endocrine therapy within 2 weeks prior to the first use of the investigational drug.
Traditional Chinese patent medicines and simple preparations or traditional Chinese medicine with anti-tumor indication within 1 week before the first use of the study drug.
Trial design
Design model
Single group
Treatments tested in this trial
ILB-3101
Biological/VaccineThere are eight escalating dose cohorts.
Treatment groups
240 Participants
are divided into 1 treatment groupGroup A: ILB-3101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT
Dose-limiting toxicity for ILB-3101
Time frame
Up to day 21 from the first dose2
MTD
Maximum tolerated dose (MTD) for ILB-3101
Time frame
Up to day 21 from the first doseSecondary outcomes
1
ORR
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.
Time frame
From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months2
Incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.
Time frame
From the first dose through 90 days post end of treatment3
Percentage of participants with antibodies to ILB-3101 in serum
Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points.
Time frame
From pre-dose to 90 days post end of treatmen4
Observed maximum plasma concentration (Cmax) of ILB-3101 in participants with advanced solid tumor
Cmax will be obtained following administration of the first dose of ILB-3101 during the first cycle.
Time frame
From pre-dose to 21 days after the first dose on Cycle 1Sponsors and contacts
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Source ClinicalTrials.gov