NCT03872206

Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression

Completed Phase 1 Last updated 7 June 2024

What this trial tests

Phase 1 trial testing HPN536 Fixed IV 6 to 560 ng/kg in Advanced Cancers Associated With Mesothelin Expression in 95 participants. Completed in 4 January 2023.

Timeline

16 April 2019

Primary endpoint
4 January 2023

4 January 2023

Quick facts

Lead sponsor	Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	95
Start date	16 April 2019
Primary completion	4 January 2023
Estimated completion	4 January 2023
Sites	16 locations across United States

Drugs / interventions tested

• HPN536 Fixed IV 6 to 560 ng/kg — full drug profile →
• HPN536 1 Prime Step IV 600-1200 ng/kg Target — full drug profile →
• 2 Prime Step IV 900-14000 ng/kg Target — full drug profile →

Conditions studied

• Advanced Cancers Associated With Mesothelin Expression — all drugs for Advanced Cancers Associated With Mesothelin Expression →

Sponsor

Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

18 and older, any sex, with Advanced Cancers Associated With Mesothelin Expression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An open-label, Phase 1/2a study of HPN536 as monotherapy to assess the safety, tolerability and PK in patients with advanced cancers associated with mesothelin expression.(Phase 2 portion of the study was not conducted.)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Overcoming Challenges for CD3-Bispecific Antibody Therapy in Solid Tumors.
   Middelburg J, Kemper K, Engelberts P, Labrijn AF, et al · · 2021 · cited 122× · PMID 33466732 · DOI 10.3390/cancers13020287
2. Mesothelin as a biomarker for targeted therapy.
   Lv J, Li P, Li P. · · 2019 · cited 101× · PMID 31463062 · DOI 10.1186/s40364-019-0169-8
3. Overcoming the challenges associated with CD3+ T-cell redirection in cancer.
   Singh A, Dees S, Grewal IS. · · 2021 · cited 82× · PMID 33469153 · DOI 10.1038/s41416-020-01225-5
4. Mesothelin: An Immunotherapeutic Target beyond Solid Tumors.
   Faust JR, Hamill D, Kolb EA, Gopalakrishnapillai A, et al · · 2022 · cited 72× · PMID 35326701 · DOI 10.3390/cancers14061550
5. Principles and Current Clinical Landscape of Multispecific Antibodies against Cancer.
   Elshiaty M, Schindler H, Christopoulos P. · · 2021 · cited 71× · PMID 34073188 · DOI 10.3390/ijms22115632
6. When three is not a crowd: trispecific antibodies for enhanced cancer immunotherapy.
   Tapia-Galisteo A, Compte M, Álvarez-Vallina L, Sanz L. · · 2023 · cited 70× · PMID 36793863 · DOI 10.7150/thno.81494
7. Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
   Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z
8. Preclinical Characterization of HPN536, a Trispecific, T-Cell-Activating Protein Construct for the Treatment of Mesothelin-Expressing Solid Tumors.
   Molloy ME, Austin RJ, Lemon BD, Aaron WH, et al · · 2021 · cited 40× · PMID 33262134 · DOI 10.1158/1078-0432.ccr-20-3392