Clinical trials: sponsored by Hutchmed
Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 Mutation
HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial evaluating the efficacy and safety of HMPL-306 in participants with postoperative residual or recurrent grade 2 gliomas carrying…
- Trial name
- NCT07912398
- Testing
- HMPL-306 tablet
- Volunteers
- 210 people
- Sponsor
- Hutchmed
Advanced Renal Cell Carcinoma
Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy as…
- Trial name
- NCT05522231
- Testing
- fruquintinib+sintilimab, axitinib / everolimus, fruquintinib
- Where
- 48 sites in China
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Solid Tumor, Adult
HMPL-A830 in Solid Tumors
This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are…
- Trial name
- NCT07718581
- Testing
- HMPL-A830
- Where
- 14 sites in United States, China
- Volunteers
- 147 people
- Sponsor
- Hutchmed
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
The goal of this study is to evaluate the efficacy of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).
- Trial name
- NCT06601504
- Testing
- HMPL-760 planned dose 1, R-GemOx, HMPL-760 planned dose 2
- Where
- 16 sites in China
- Volunteers
- 61 people
- Sponsor
- Hutchmed
Solid Tumors, Adult
A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors
This is a first-in-human (FIH), phase Ⅰ/Ⅱa, open-label, multicenter clinical study of HMPL-A251 monotherapy in adult participants with unresectable, advanced or metastatic HER2-expressing solid tumors.
- Trial name
- NCT07228247
- Testing
- HMPL-A251
- Where
- 15 sites in United States, China
- Volunteers
- 147 people
- Sponsor
- Hutchmed
Non-small Cell Lung Cancer
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
A Phase III Clinical Study on Savolitinib Combined with Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Trial name
- SANOVO (NCT05009836)
- Testing
- Savolitinib, Osimertinib
- Where
- China
- Volunteers
- 412 people
- Sponsor
- Hutchmed
Healthy Participants
A Study on the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of HMPL-760 Capsules
This is a single-center, open-label, randomized, four-period, six-sequence study with a planned enrollment of 24 healthy participants.
- Trial name
- NCT07643272
- Testing
- HMPL-760, Rabeprazole and HMPL-760
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Solid Tumors, Adult
HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor
This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.
- Trial name
- NCT07396584
- Testing
- HMPL-A580
- Where
- 14 sites in United States, China
- Volunteers
- 186 people
- Sponsor
- Hutchmed
Metastatic Pancreatic Cancer
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
- Trial name
- NCT06361888
- Testing
- Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, Nab-paclitaxel Plus Gemcitabine, Surufatinib with Nab-paclitaxel, and Gemcitabine
- Where
- 52 sites in China
- Volunteers
- 502 people
- Sponsor
- Hutchmed
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
This is a Phase III randomized, double-blind, positive controlled study to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with…
- Trial name
- NCT07409428
- Testing
- HMPL-760, R-GemOx
- Where
- 50 sites in China
- Volunteers
- 240 people
- Sponsor
- Hutchmed
Health, Subjective
The Study on Effects of CYP3A and P-glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampin of HMPL-453 Tartrate Tablets
Primary objective： 1. To evaluate the effect of Itraconazole ( CYP3A and P-gp inhibitors) on HMPL-453 pharmacokinetics(PK) in healthy subjects 2.
- Trial name
- NCT07697157
- Testing
- HMPL-453 with Itraconazole, HMPL-453 with Rifampin
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Mass Balance Study
Study on [14C]HMPL-453（FGFR Inhibitor） in Healthy Chinese Adult Male Subjects
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HMPL-453
- Trial name
- NCT07644442
- Testing
- HMPL-453
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Warm Antibody Autoimmune Hemolytic Anemia
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA. Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA.
- Trial name
- wAIHA (NCT05535933)
- Testing
- HMPL-523(300mg PO QD)
- Where
- 39 sites in China
- Volunteers
- 111 people
- Sponsor
- Hutchmed
Primary Immune Thrombocytopenia (ITP)
Phase III Study on HMPL-523 for Treatment of ITP
The purpose of this study is to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP).
- Trial name
- NCT05029635
- Testing
- HMPL-523
- Where
- 37 sites in China
- Volunteers
- 272 people
- Sponsor
- Hutchmed
Isocitrate Dehydrogenase Gene Mutation
A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.
- Trial name
- NCT04762602
- Testing
- HMPL-306
- Where
- 11 sites in United States, Spain
- Volunteers
- 42 people
- Sponsor
- Hutchmed
Non Hodgkin Lymphoma
An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma
This is a Phase I, open-label, multicenter study of HMPL-523 administered orally to patients with relapsed or refractory lymphoma who have exhausted approved therapy options.
- Trial name
- NCT03779113
- Testing
- HMPL-523
- Where
- 32 sites in United States, Denmark and 5 more
- Volunteers
- 69 people
- Sponsor
- Hutchmed
Healthy
Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets
This is a single-center, open-label, randomized, three-period, six-sequence study to evaluate the effect of food (high-fat and low-fat) on the PK of HMPL-523.
- Trial name
- NCT07348133
- Testing
- HMPL-523
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Healthy
Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans
Two formulations containing the same active pharmaceutical ingredient are considered bioequivalent if their relative bioavailability (rate and extent of drug absorption) falls within acceptable predetermined limits after…
- Trial name
- NCT07331194
- Testing
- HMPL-523 Acetate Tablets (Test Formulation), HMPL-523 Acetate Tablets (Reference Formulation)
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Isocitrate Dehydrogenase Gene Mutation
A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH…
- Trial name
- NCT04764474
- Testing
- HMPL-306
- Where
- 15 sites in United States, Spain
- Volunteers
- 46 people
- Sponsor
- Hutchmed
Advanced Intrahepatic Cholangiocarcinoma, Solid Tumor, Adult
HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
The goal of this clinical trial is to evaluate in patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusion/rearrangement.
- Trial name
- NCT04353375
- Testing
- HMPL-453
- Where
- China
- Volunteers
- 235 people
- Sponsor
- Hutchmed