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MABp1

Phase 1

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

MABp1 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Nov 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

MABp1 clinical trials

MABp1 · 1 trial · 1 indication

Phase 1 1
NCT01021072A First in Man Study of MABp1 in Patients With Advanced CancersAdvanced Cancers
COMPLETED52 Analytics
PHASE1COMPLETED
A First in Man Study of MABp1 in Patients With Advanced Cancers
Advanced CancersUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose
one year

Secondary Endpoints

Tumor response
one year
Cachexia Response
8 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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
MABp1DRUG0.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which thee is no standard therapy that provides benefits for \>/= 3 months * measurable or non-measurable disease at baseline * at least 4 weeks s...

Countries:United States
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Frequently asked questions about MABp1

What is MABp1?

MABp1 is an investigational small molecule developed by Johnson & Johnson (ticker JNJ) for the treatment of advanced cancers. It has been studied in a single Phase 1 first-in-man clinical trial in patients with advanced cancers, and it is not an approved therapy.

What is MABp1 used for in advanced cancers?

MABp1 has been evaluated for use in patients with advanced cancers. Its only clinical study to date was a first-in-man Phase 1 trial conducted in the United States in adults with advanced cancers, and the drug remains investigational rather than approved for any indication.

Who makes MABp1?

MABp1 is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 1 first-in-man study of MABp1 in patients with advanced cancers, which was conducted in the United States.

What phase is MABp1 in?

MABp1 is in Phase 1 development. It has completed one Phase 1 first-in-man trial in patients with advanced cancers, and no later-stage trials are recorded. The drug is investigational and has not been approved for any indication.

What clinical trials is MABp1 in?

MABp1 has been studied in one clinical trial, NCT01021072, titled A First in Man Study of MABp1 in Patients With Advanced Cancers. That Phase 1 trial enrolled 52 patients in the United States, was uncontrolled, and has been completed.

Is MABp1 FDA approved?

MABp1 is not approved and remains an investigational drug in Phase 1 clinical development. Its only recorded study, NCT01021072, was a completed first-in-man Phase 1 trial in 52 patients with advanced cancers conducted in the United States.