Phase 1 Trial of Hu5F9-G4, a CD47-targeting Antibody

NCT ID: NCT02216409

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.

Detailed Description

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This is a first-in-human, first-in-class, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (Hu5F9-G4)

Hu5F9-G4 monotherapy

Group Type EXPERIMENTAL

Hu5F9-G4

Intervention Type DRUG

Interventions

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Hu5F9-G4

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients with histologically or cytologically confirmed advanced solid malignancy or Lymphoma

Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatment.

Adequate hematologic status

Adequate coagulation function

Adequate hepatic function

Adequate renal function

Exclusion Criteria

Known primary tumors of central nervous system disease

Known active brain metastases

Known cardiopulmonary disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Takimoto, MD

Role: STUDY_CHAIR

Gilead Sciences

Locations

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Stanford Cancer Institute

Stanford, California, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

START Midwest

Grand Rapids, Michigan, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Sikic BI, Lakhani N, Patnaik A, Shah SA, Chandana SR, Rasco D, Colevas AD, O'Rourke T, Narayanan S, Papadopoulos K, Fisher GA, Villalobos V, Prohaska SS, Howard M, Beeram M, Chao MP, Agoram B, Chen JY, Huang J, Axt M, Liu J, Volkmer JP, Majeti R, Weissman IL, Takimoto CH, Supan D, Wakelee HA, Aoki R, Pegram MD, Padda SK. First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers. J Clin Oncol. 2019 Apr 20;37(12):946-953. doi: 10.1200/JCO.18.02018. Epub 2019 Feb 27.

Reference Type DERIVED
PMID: 30811285 (View on PubMed)

Liu J, Wang L, Zhao F, Tseng S, Narayanan C, Shura L, Willingham S, Howard M, Prohaska S, Volkmer J, Chao M, Weissman IL, Majeti R. Pre-Clinical Development of a Humanized Anti-CD47 Antibody with Anti-Cancer Therapeutic Potential. PLoS One. 2015 Sep 21;10(9):e0137345. doi: 10.1371/journal.pone.0137345. eCollection 2015.

Reference Type DERIVED
PMID: 26390038 (View on PubMed)

Other Identifiers

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SCI-CD47-001

Identifier Type: -

Identifier Source: org_study_id

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