Evaluation of ICP-B794 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
About this trial
An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with Advanced Solid Tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years and ≤75 years.
Histologically confirmed other locally advanced or metastatic solid tumors.
Life expectancy ≥3 months.
Adequate organs function within 7 days prior to the first dose of ICP-B794
Disqualifiers
Other active primary malignancies within 3 years prior to the first dose of investigational product.
Prior or current treatment with the similar drug or related treatment specified in the protocol.
Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol.
Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0).
Trial design
Design model
Single group
Treatments tested in this trial
ICP-B794
DrugIntravenous administration once every 3 weeks
Treatment groups
410 Participants
are divided into 1 treatment groupGroup A: ICP-B794Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0
Time frame
Up to 2 years2
Dose-limiting toxicities (DLT)
Incidence, character, and severity of dose-limiting toxicities.
Time frame
Up to 2 years3
The Recommended Dose (RD) of ICP-B794 for expansion and Maximum Tolerated Dose (MTD)
Time frame
Up to 2 years4
Objective response rate (ORR)
Time frame
Up to 2 yearsSecondary outcomes
1
Maximum Plasma Concentration (Cmax)
Time frame
Up to 2 years2
Time to Maximum Plasma Concentration (Tmax)
Time frame
Up to 2 years3
Half-life (T1/2)
Time frame
Up to 2 years4
Area under the concentration-time curve from zero time to infinity (AUC0-∞)
Time frame
Up to 2 yearsOther outcomes
1
B7-H3 protein expression
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
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