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A Trial of Hu5F9-G4 With Avelumab in Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03558139
Recruitment Status : Active, not recruiting
First Posted : June 15, 2018
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Forty Seven, Inc.

Tracking Information
First Submitted Date  ICMJE May 30, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE May 24, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2018)
  • Dose-Limiting Toxicities [ Time Frame: 35-Days ]
    Number of participants with dose-limiting toxicities and treatment-related adverse events as assessed by CTCAE v4.03.
  • Objective Response Rate [ Time Frame: 8 Weeks ]
    Evaulate anti-tumor activity based on RECIST v1.1, irRECIST, and Gynecologic Cancer Intergroup (GCIG) response criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Hu5F9-G4 With Avelumab in Ovarian Cancer
Official Title  ICMJE A Phase 1b Trial of Hu5F9-G4 in Combination With Avelumab in Solid Tumor Patients and Checkpoint Inhibitor Naïve Ovarian Cancer Patients Who Progress Within 6 Months of Prior Platinum Chemotherapy
Brief Summary This is an open label, multicenter, Phase 1b trial investigating the combination of Hu5F9 G4 and avelumab in patients with solid tumors and ovarian cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Ovarian Cancer
Intervention  ICMJE
  • Drug: Hu5F9-G4
    Hu5F9-G4
  • Drug: Avelumab
    Avelumab
Study Arms  ICMJE Experimental: Treatment
Combination of Hu5F9-G4 and avelumab.
Interventions:
  • Drug: Hu5F9-G4
  • Drug: Avelumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2018)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Safety Run-in: Pathologically confirmed advanced solid tumors.
  • Ovarian Cancer Expansion: Histologically or cytologically confirmed, epithelial ovarian, fallopian tube, or peritoneal cancer.
  • Ovarian Cancer Expansion: Checkpoint inhibitor naïve patients.
  • Ovarian Cancer Expansion: Willing to consent to 1 mandatory pre treatment and 1 on-treatment tumor biopsy.
  • Adequate performance status. Adequate hematological, liver, and kidney functions.
  • Availability of pre-treatment tumor tisse to evaulate PD-L1 expression.

Exclusion Criteria:

  • Patients with symptomatic or untreated central nervous system (CNS) metastases.
  • Prior treatment with CD47 or SIRPα targeting agents.
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV).
  • RBC transfusion dependence.
  • Prior organ transplantation requiring immunosuppression or active autoimmune disease.
  • Significant medical diseases and/or history of uncontrolled intercurrent illness or other serious medical condition.
  • Pregnancy or active breast feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03558139
Other Study ID Numbers  ICMJE 5F9006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forty Seven, Inc.
Study Sponsor  ICMJE Forty Seven, Inc.
Collaborators  ICMJE Merck KGaA, Darmstadt, Germany
Investigators  ICMJE Not Provided
PRS Account Forty Seven, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP