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A Trial of Hu5F9-G4 With Avelumab in Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03558139
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Forty Seven, Inc.

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Ovarian Cancer Drug: Hu5F9-G4 Drug: Avelumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Avelumab

Arm Intervention/treatment
Experimental: Treatment
Combination of Hu5F9-G4 and avelumab.
Drug: Hu5F9-G4
Hu5F9-G4

Drug: Avelumab
Avelumab




Primary Outcome Measures :
  1. 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.

  2. Objective Response Rate [ Time Frame: 8 Weeks ]
    Evaulate anti-tumor activity based on RECIST v1.1, irRECIST, and Gynecologic Cancer Intergroup (GCIG) response criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558139


Contacts
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Contact: Gani Chico, MD (650) 352-4150 info@fortyseveninc.com

Locations
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United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Oklahoma
University of Oklahoma Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Forty Seven, Inc.
Merck KGaA, Darmstadt, Germany

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Responsible Party: Forty Seven, Inc.
ClinicalTrials.gov Identifier: NCT03558139     History of Changes
Other Study ID Numbers: 5F9006
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies, Monoclonal
Hu5F9-G4
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents