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MABp1

Phase 1

Advanced Cancers | Small molecule | Oncology |Johnson & Johnson|Last Updated: Feb 16, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

MABp1 · 2 trials · 2 indications

Phase 1 2
NCT03047317A Pharmacokinetic Study of MABp1 in Healthy VolunteersHealthy
COMPLETED6 Analytics
NCT01021072A First in Man Study of MABp1 in Patients With Advanced CancersAdvanced Cancers
COMPLETED52 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study of MABp1 in Healthy Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
A First in Man Study of MABp1 in Patients With Advanced Cancers
Advanced CancersUnlock trial analytics

Study Endpoints

Primary Endpoints

Peak Plasma Concentration
2 weeks

Pharmacokinetics--blood levels of MABp1 antibody

Time to Peak Plasma Concentration
2 weeks

Pharmacokinetics--blood levels of MABp1 antibody

Half Life
2 weeks

Pharmacokinetics--blood levels of MABp1 antibody

Area under the plasma concentration versus time curve
2 weeks

Pharmacokinetics--blood levels of MABp1 antibody

Maximum tolerated dose
one year

Secondary Endpoints

Incidence of treatment emergent adverse events
2 weeks
Tumor response
one year
Cachexia Response
8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MABp1EXPERIMENTAL -
MTDEXPERIMENTALThe study will utilize a standard 3+3 design for dose escalation. Once the maximum tolerated dose has been reached, an expansion cohort, as well as tumor specific expansion cohorts will be explored.

Interventions

NameTypeDescription
MABp1BIOLOGICALSingle dose of intravenous MABp1
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: ≥18 2. Adequate bone marrow function as defined as: * absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L) * platelet count \> 150,000/mm3 * hemoglobin of ≥ 10 g/dL 3. Adequate renal function, defined by serum creatinine ≤ 1.5 x lab U...

Countries:United States
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Frequently asked questions about MABp1

What is MABp1 used for?

MABp1 is an investigational drug being studied for use in advanced cancers and in healthy volunteers. It is in Phase 1 clinical development for oncology indications. The drug is not approved and remains under investigation.

Who makes MABp1?

MABp1 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is in Phase 1 clinical development.

What phase is MABp1 in?

MABp1 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in patients with advanced cancers and one in healthy volunteers. The drug is investigational and not yet approved.

What clinical trials is MABp1 in?

MABp1 has been studied in two completed Phase 1 trials. NCT01021072 enrolled 52 patients with advanced cancers in the United States. NCT03047317 enrolled 6 healthy volunteers in the United States. Both trials are completed.

Is MABp1 the same as any other drug?

No alternative names for MABp1 have been disclosed. The drug is known only by the name MABp1 in its clinical development program.