Solid TumorPhase 1NCT02216409
Phase 1 Trial of Hu5F9-G4, a CD47-targeting Antibody
A Phase 1 study testing Hu5F9-G4 in people with Solid Tumor, run by Gilead Sciences at 6 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Hu5F9-G4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2014to Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known primary tumors of central nervous system disease
- Known active brain metastases
- Known cardiopulmonary disease
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Chicago
Chicago, Illinois, 60637
START Midwest
Grand Rapids, Michigan, 49503
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Oklahoma
Oklahoma City, Oklahoma, 73104
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Stanford Cancer Institute
Stanford, California, 94305
About this study
Official title: A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.
Read the detailed description
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
- Solid Tumor
- Being tested
- Hu5F9-G4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hu5F9-G4Drug
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Hu5F9-G4) | Experimental | Hu5F9-G4 monotherapy Receives: Drug: Hu5F9-G4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Hu5F9-G4
The CTCAE criteria will be used to assess adverse events on this trial.
Measured: The first 28 days on study, for determination of Dose Limiting Toxicities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Takimoto, MD, Study chair, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216409
- Sponsor's protocol ID
- SCI-CD47-001
- Status last verified
- Feb 2019
- First submitted
- 12 Aug 2014
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Cai S, Wei X, Li Q, Jiang Z, Li L. Smart materials in pharmacological drug development: Neutrophils and its constituents for drug delivery and consequent antitumor effects. Mol Immunol. 2025 Jul;183:18-32. doi: 10.1016/j.molimm.2025.04.010. Epub 2025 May 2.
PubMed 40318595Sikic 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.
PubMed 30811285Liu 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.
PubMed 26390038
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT02216409
- Acronym / sponsor ID
- SCI-CD47-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Hu5F9-G4) | Experimental | Drug: Hu5F9-G4Hu5F9-G4 monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Known primary tumors of central nervous system disease
- Known active brain metastases
- Known cardiopulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hu5F9-G4 | Drug | Treatment (Hu5F9-G4) |
Primary outcome
Safety and Tolerability of Hu5F9-G4
Time frame: The first 28 days on study, for determination of Dose Limiting Toxicities
The CTCAE criteria will be used to assess adverse events on this trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 40318595Cai S, Wei X, Li Q, Jiang Z, Li L. Smart materials in pharmacological drug development: Neutrophils and its constituents for drug delivery and consequent antitumor effects. Mol Immunol. 2025 Jul;183:18-32. doi: 10.1016/j.molimm.2025.04.010. Epub 2025 May 2.
- Derived from this study: PubMed 30811285Sikic 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.
- Derived from this study: PubMed 26390038Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Takimoto, MD study chair
Gilead Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hu5F9-G4 in people with Solid Tumor, run by Gilead Sciences at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Hu5F9-G4 (time frame: The first 28 days on study, for determination of Dose Limiting Toxicities). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216409, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.