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

Multiple Myeloma Clinical Trial

Official title:

A Phase 1 Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04184050
• Other study ID #: HPN217-3001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 1, 2020
• Est. completion date: June 2, 2024

Study information

• Verified date: September 2023
• Source: Harpoon Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: June 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Major Inclusion Criteria:

1. Patients =18 years of age at the time of signing informed consent

2. 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.

3. 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).

4. Measurable disease defined as at least one of the following:

1. Serum M-protein =0.5 g/dL

2. Urine M-protein =200 mg/24 hours

3. 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)

5. 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:

1. Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)

2. Patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease.

3. Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the start of study

4. Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded.

5. 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

6. 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma of Bone
• Multiple Myeloma With Failed Remission
• Neoplasms, Plasma Cell

Intervention

Drug:
• HPN217
HPN217 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains

Locations

Country	Name	City	State
France	The Centre Hospitalier Universitaire de Lille	Lille
France	Centre Hospitalier Universitaire De Nantes	Nantes
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
Spain	Josep Carreras Leukaemia Research Institute	Barcelona
Spain	Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)	Madrid
Spain	Clínica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca	Salamanca
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	The University of Kansas Cancer Center	Fairway	Kansas
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	OHSU	Portland	Oregon
United States	University of Rochester James P Wilmot Cancer Institute	Rochester	New York
United States	University of Washington - Seattle Cancer Center Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Harpoon Therapeutics

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of treatment-emergent AEs (TEAEs) graded according to NCI CTCAE version 5.0 (ASTCT grading criteria for CRS and ICANS)		4 years
Primary	Number and severity of DLTs following treatment with HPN217		4 years
Secondary	Best Overall Response (BOR)		4 years
Secondary	Overall response rate (ORR) based on current IMWG response criteria		4 years
Secondary	Progression-free survival (PFS) and overall survival (OS)		4 years
Secondary	Duration of response (DOR)		4 years
Secondary	Time to response (TTR)		4 years
Secondary	Incidence of ADAs against HPN217		4 years
Secondary	Titers of ADAs against HPN217		4 years
Secondary	Minimal Residual Disease (MRD) negative		4 years