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IMP761

Phase 1

Healthy | Small molecule | Other |Immutep Limited|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06637865A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy VolunteersPHASE1 RECRUITING 79 — — Jul 17, 2024Aug 31, 2026Apr 23, 20261 Netherlands
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Study Endpoints
Primary Endpoints
Occurrence of clinically relevant abnormalities in vital signs
From screening to the follow up visit after last treatment (up to 143 days)
Frequency of adverse events (AEs)
From administration to the follow up visit after last treatment (up to 103 days)
Duration of adverse events (AEs)
From administration to the follow up visit after last treatment (up to 103 days)
Severity of adverse events (AEs)
From administration to the follow up visit after last treatment (up to 103 days)
Occurrence of clinically relevant abnormalities in electrocardiography
From screening to the follow up visit after last treatment (up to 143 days)
Occurrence of clinically relevant abnormalities in safety laboratory assessments
From screening to the follow up visit after last treatment (up to 143 days)
Secondary Endpoints
Pharmacokinetic (PK) parameter: Maximum Serum Concentration (Cmax) (Part B and C)
Up to 86 days
PK parameter: Timepoint of Maximum Serum Concentration (tmax) (Part B and C)
Up to 86 days
PK parameter: Minimum Serum concentration (Cmin) (Part B and C)
Up to 86 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single ascending dose IMP761 Part AEXPERIMENTALRandomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects
Single ascending dose Placebo Part APLACEBO_COMPARATORRandomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects
Single ascending dose IMP761 Part B KLH challengeEXPERIMENTALRandomized in 4:1 (IMP761:placebo). KLH immunization followed by IMP761 on Day 1 and dermal rechallenge on day 2 (Cohorts 2-3) or on days 2, 9 and 23 (Cohorts 4-8) Cohort 2: 5 subjects; Cohort 3: 5 subjects; Cohort 4: 10 subjects; Cohort 5: 10 subjects; Cohort 6: 10 subjects; Cohort 7: 10 subjects; Cohort 8: 10 subjects
Single ascending dose Placebo Part B KLH challengePLACEBO_COMPARATORRandomized in 4:1 (IMP761:placebo). KLH immunization followed by placebo on Day 1 and dermal rechallenge on day 2 (Cohorts 2-3) or on days 2, 9 and 23 (Cohorts 4-8) Cohort 2: 5 subjects; Cohort 3: 5 subjects; Cohort 4: 10 subjects; Cohort 5: 10 subjects; Cohort 6: 10 subjects; Cohort 7: 10 subjects; Cohort 8: 10 subjects
Multiple ascending dose IMP761 Part CEXPERIMENTALRandomized 5:2 (IMP761:placebo) every 28 days, 3 times. MAD Cohort 1: 7 subjects; MAD Cohort 2: 7 subjects
Multiple dose placebo Part CPLACEBO_COMPARATORRandomized 5:2 (IMP761:placebo) every 28 days, 3 times. MAD Cohort 1: 7 subjects; MAD Cohort 2: 7 subjects
Interventions
NameTypeDescription
IMP761DRUGintravenous
PlaceboDRUGintravenous
keyhole limpet haemocyanin (KLH)OTHERintramuscular immunization and intradermal challenge
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Signed informed consent and willing and able to comply with the study protocol; 2. Healthy men or women, 18 to 55 years of age (inclusive) at screening. The health status is verified by absence of evidence of any clinically significant active or uncontrolled chronic disease f...

Countries:Netherlands
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06637865primaryCompletionDate: changed
LOWMay 24, 2026NCT06637865studyFirstPostDate: changed