Clinical trial · Interventional
Phase 1 Trial of Hu5F9-G4, a CD47-targeting Antibody
A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies
NCT02216409CI-TRIAL-00036944completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hu5F9-G4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Hu5F9-G4)
- description
- Hu5F9-G4 monotherapy
- interventionNames
- Drug: Hu5F9-G4
Primary outcomes (1)
- measure
- Safety and Tolerability of Hu5F9-G4
- timeFrame
- The first 28 days on study, for determination of Dose Limiting Toxicities
- description
- The CTCAE criteria will be used to assess adverse events on this trial.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDCai 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. PMID 40318595
- DERIVEDSikic 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. PMID 30811285
- DERIVEDLiu 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. PMID 26390038