A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy
ConditionAdvanced Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorImmuneOncia Therapeutics Inc.
About this trial
This is an Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients with Advanced Cancer Failed to Standard Therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed ICF
Adult (19 years or older)
Diagnosis and prior therapies
Histologically or cytologically proven metastatic or locally advanced of hepatocellular carcinoma (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors)
Disqualifiers
Treatment with nonpermitted drugs
Prior treatment with a CD47 or SIRPα targeting agent
Concurrent anticancer treatments
Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period
Trial design
Design model
Single group
Treatments tested in this trial
IMC-002
Biological/VaccinePart 1: Dose escalation IMC-002 5, 10, 20, and 30 mg/kg over 3 hours (±30 minutes) intravenous (IV) infusion every 2 weeks Part 2: Expansion cohort IMC-002 20 mg/kg over 3 hours (±30 minutes) IV infusion at the first cycle, if the first infusion is tolerated, then over 1 to 1.5 hours (±10 minutes) IV infusion at all following cycles every 3 weeks In hepatocellular (HCC) Cohort, Lenvatinib 8 mg once daily (body weight of \< 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In triple negative breast cancer (TNBC) Cohort, Paclitaxel 175 mg/m2 IV infusion on Day 1 of each cycle, or Gemcitabine 1,000 mg/m2 followed by Carboplatin AUC 2 IV infusion on Day 1 and Day 8 of each cycle In biliary tract cancer (BTC) and pancreatic ductal adenocarcinoma (PDAC) Cohort, Lenvatinib 8 mg once daily (body weight of \< 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In B-cell lymphoma Cohort, Rituximab 375 mg/m2 IV infusion on Day 1 of each cycle
Treatment groups
86 Participants
are divided into 1 treatment groupGroup A: IMC-002Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose-Limiting Toxicities (DLTs)
To determine maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002
Time frame
21 days2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
* clinically significant changes in physical examination, vital signs, ECG parameters, clinical laboratory tests, AEs * Immunogenicity: anti-IMC-002 antibody
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Pharmacokinetics Endpoint : Cmax
maximum observed serum concentration (Cmax) of IMC-002
Time frame
through study completion, an average of 1 year2
Pharmacokinetics Endpoint : Ctrough
minimum observed serum concentration immediately before dosing (Ctrough) of IMC-002
Time frame
through study completion, an average of 1 year3
Pharmacokinetics Endpoint : Tmax
time of the maximum observed serum concentration (Tmax) of IMC-002
Time frame
through study completion, an average of 1 year4
Pharmacokinetics Endpoint : AUC
Area Under the Serum Concentration-Time Curve (AUC) of IMC-002
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov