Multiple Myeloma Clinical Trial

A Phase 1 Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and PK of HPN217 in Patients With R/R MM

Summary

An open-label, Phase 1 study of HPN217 to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

View Eligibility Criteria

Eligibility Criteria

Major Inclusion Criteria:

Patients ≥18 years of age at the time of signing informed consent
Documented RRMM for which no standard therapy options are anticipated to result in a durable remission. Relapse defined as progressive disease after initial response (minimal response [MR] or better) to previous treatment, more than 60 days after cessation of last treatment. Refractory disease defined as <25% reduction in M protein or progression of disease during treatment or within 60 days after cessation of treatment.
Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).

Measurable disease defined as at least one of the following:

Serum M-protein ≥0.5 g/dL
Urine M-protein ≥200 mg/24 hours
Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤1.

Major Exclusion Criteria:

Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)
Patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease.
Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study
Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded.
History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received any treatment for their autoimmune disorder in the past 3 years
Second primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3-year remission: non-melanoma skin cancer, resected melanoma in situ, in situ cervical cancer, adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ≥2 years, low-risk prostate cancer with Gleason score <7 and prostate-specific antigen <10 ng/mL

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT04184050

Recruitment Status:

Recruiting

Sponsor:

Harpoon Therapeutics

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There are 18 Locations for this study

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Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Lisa Bismarck, RN, MSN
Contact
480-256-5463
[email protected]
Sumit Madan, MD
Principal Investigator
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States More Info
Ayodele Adeyemi
Contact
480-342-6066
[email protected]
Leif Bergsegal, MD
Principal Investigator
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States More Info
Joseph Maroge
Contact
858-246-0682
[email protected]
Caitlin Costello, MD
Principal Investigator
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
James Vick, MHA
Contact
720-754-4890
[email protected]
Henning Schade, MD
Principal Investigator
The University of Kansas Cancer Center
Fairway Kansas, 66205, United States More Info
Leah Miller, MS, CCRP
Contact
913-945-7538
[email protected]
Al-Ola Abdallah, MD
Principal Investigator
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States More Info
ct.gov Contact
Contact
800-767-9355
[email protected]
Jens Hillengass, MD, PhD
Principal Investigator
University of Rochester James P Wilmot Cancer Institute
Rochester New York, 14642, United States More Info
Brea Lipe, MD
Contact
585-275-4099
[email protected]
Brea Lipe, MD
Principal Investigator
OHSU
Portland Oregon, 97239, United States More Info
Chris Seybold
Contact
503-494-9298
[email protected]
Eva Medvedova, MD
Principal Investigator
Swedish Cancer Institute
Seattle Washington, 98104, United States More Info
Krystle Pagarian
Contact
206-386-2098
[email protected]
Raya Mawad, MD
Principal Investigator
University of Washington - Seattle Cancer Center Alliance
Seattle Washington, 98109, United States More Info
Erica Kalista
Contact
206-606-7099
[email protected]
Andrew Cowan, MD
Principal Investigator
The Centre Hospitalier Universitaire de Lille
Lille , 59000, France More Info
Salomon Manier, Dr.
Contact
+33 (0)3 20 44 42 90
[email protected]
Centre Hospitalier Universitaire De Nantes
Nantes , 44093, France More Info
Cyrille Touzeau
Contact
+33 2 53 48 24 05
[email protected]
Cyrille Touzeau, MD
Principal Investigator
Centre Hospitalier Universitaire de Poitiers
Poitiers , 86021, France More Info
Xavier Leleu, MD
Contact
+33 549 443 717
[email protected]
Xavier Leleu, MD
Principal Investigator
Universitatsklinik Tuebingen
Tübingen , 72076, Germany More Info
Britta Besemer, MD
Principal Investigator
Clínica Universidad de Navarra
Pamplona Navarra, 31008, Spain More Info
Maite San Miguel
Contact
948 255 400
[email protected]
Paula Rodriguez Otero, MD
Principal Investigator
Josep Carreras Leukaemia Research Institute
Barcelona , 08916, Spain More Info
Albert Oriol, MD
Contact
+34934978547
[email protected]
Albert Oriol, MD
Principal Investigator
Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
Madrid , 28040, Spain More Info
Daniel Morillo, MD
Contact
+0034913908922
[email protected]
Daniel Morillo, MD
Principal Investigator
Hospital Universitario de Salamanca
Salamanca , 37007, Spain More Info
Maria-Victoria Mateos Manteca, MD
Contact
+340639455880
[email protected]
Maria-Victoria Mateos Manteca, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT04184050

Recruitment Status:

Recruiting

Sponsor:


Harpoon Therapeutics

How clear is this clinincal trial information?

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