Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas

Stopped early · Phase 1

Conditions studied: Lymphoma

In brief

An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability and PK of HMPL-689 in patients with relapsed or refractory lymphomas

Key facts

Study ID

NCT03786926

Run by

Hutchmed

People needed

53

Starts

2019-08-26

Expected to finish

2024-06-26

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (ECOG) performance status of 0 or 1;
• Histologically confirmed lymphoma (tumor types are restricted to CLL/SLL, FL (grade 1-3a), MCL, MZL, LPL/WM, PTCL or CBCL);
• Patients with relapsed or refractory NHL for whom:
• Standard of care treatment options no longer exist (Stage 1 only);
• Standard of care treatment options no longer exist with the exception of PI3K-delta inhibitors (Stage 2 only);
• Expected survival of more than 24 weeks.

You may not qualify if…

• Patients who meet any of the following criteria will be excluded from study entry:
• Primary central nervous system (CNS) lymphoma;
• Any of the following laboratory abnormalities Absolute neutrophil count; <1.0×10\^9/L, Hemoglobin <80 g/L Platelets <50 ×10\^9/L
• Inadequate organ function, defined by the following:
• Total bilirubin ≥1.5 times the upper limit of normal (× ULN);
• AST or ALT > 2.5 × ULN;
• Estimated creatinine clearance (CrCl) per Cockcroft-Gault;
• Dose Escalation stage of trial (Stage 1) - CrCl < 40 mL/min;
• Dose Expansion stage of trial (Stage 2) - CrCl <30 mL/min;
• International normalized ratio (INR) > 1.5 × ULN, activated partial thromboplastin time (aPTT) > 1.5 × ULN;
• Serum amylase or lipase > ULN at screening or known medical history of serum amylase or lipase > ULN;
• Patients with presence of second primary malignant tumors within the last 2 years;
• Clinically significant history of liver disease;
• Prior treatment with any PI3Kδ inhibitors;
• Any prior use of the following: cancer therapy within 3 weeks of study treatment, GCSF within 7 days of screening, steroid therapy or targeted anti-neoplastic intent within 7 days of treatment, any use of strong CYP3A4 inducers within 2 weeks prior to initiation of study treatment, prior autologous transplant within 6 months of study treatment, prior allogenic stem cell transplant within 6 months of study treatment;
• Clinically significant active infection or interstitial lung diseases (including drug induced pneumonitis);
• Major surgical procedure within 4 weeks prior to initiation of study treatment;
• Adverse events from prior anti-neoplastic therapy that have not resolved to Grade less than or equal to 1, except for alopecia;
• New York Heart Association (NYHA) Class II or greater congestive heart failure;
• Congenital long QT syndrome or QTc >470 msec;
• Currently use medication known to cause QT prolongation or torsades de pointes;
• History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment;
• History of stroke or transient ischemic attack within 6 months prior to initiation of study treatment;
• Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease;
• History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis);

Where it is running

• Innovative Clinical Research Institute — Anaheim, California, United States
• Pacific Cancer Medical Center — Anaheim, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Clinical Research Alliance, Inc — Westbury, New York, United States
• Levine Cancer Institute- Atrium Health — Charlotte, North Carolina, United States
• Baylor Scott and White Research Institute — Dallas, Texas, United States
• Renovatio Clinical — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Medical Oncology Associates, P.S. — Spokane, Washington, United States
• Helsingin yliopistollinen keskussairaala — Helsinki, Finland
• Tampereen yliopistollinen sairaala — Tampere, Finland
• Hopital Henri Mondor — Créteil, Val De Marne, France
• CHU de Nantes - Hotel Dieu — Nantes, France
• CHU de Bordeaux - Hôpital Haut-Lévêque — Pessac, France
• Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS — Bologna, Italy
• Ospedale San Raffaele — Milan, Italy
• KO-MED Centra Kliniczne — Biała Podlaska, Poland
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
• BioResearch Group Sp. Z. o. o. — Krakow, Poland
• NASZ LEKARZ Osrodek Badan Klinicznych — Torun, Poland
• Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego — Wroclaw, Poland
• ICO Badalona - Hospital Universitari Germans Trias i Pujol — Barcelona, Spain
• ICO l'Hospitalet - Hospital Duran i Reynals — Barcelona, Spain
• Fundacion Jimenez Diaz — Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.