Trial · NCT03779113
An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma
NCT03779113, Phase 1, Terminated, Hutchmed; results first posted 2026-02-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma. Trials, record NCT03779113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03779113
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma
- NCT number
- NCT03779113
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 69 participants, actual
- Lead sponsor
- Hutchmed
- Conditions
- Non Hodgkin Lymphoma
- Interventions
- HMPL-523
- First posted
- 2018-12-19
- Last updated
- 2026-02-18
- Results first posted
- 2026-02-18
- Limitations and caveats
- The study was terminated based on strategic decision made by the Sponsor to discontinue development of HMPL-523 for lymphoma in the United States, Europe, and Australia with no safety concerns.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days) | A DLT was defined as the occurrence of any of the following treatment-emergent adverse events (TEAEs) during the DLT assessment window, unless clearly unrelated to the study treatment. AEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0: non-hematologic toxicity: all non-hematologic TEAEs of Grade 3 or greater with the exception of Grade 3 nausea or vomiting controlled by supportive therapy; hematologic toxicity: Grade 4 neutropenia \>5 days, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or which required platelets transfusion, Grade \>=3 febrile neutropenia (defined as absolute neutrophil count \<1000/cubic millimeter with a single temperature \>38.3 degree Celsius \[°C\] or a sustained temperature of \>=38°C for more than 1 hour), Grade 4 anemia not explained by underlying disease; any TEAE that required a dose delay of \>=15 days; any case of Hy's Law. |
| Primary | Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months | An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. TEAEs were defined as AEs with an onset date on or after the first dose of study treatment and no later than 30 days after the date of last study treatment administration or start of a new treatment of anti-neoplasm therapy, whichever was earlier. Treatment related AEs were the TEAEs that were reported as related to study treatment by the Investigator. |
| Primary | Dose Escalation Stage: Recommended Phase 2 Dose of HMPL-523 | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days) | RP2D was based on the pharmacokinetics (PK), safety, and tolerability assessments in dose escalation stage patients. |
| Primary | Dose Expansion Stage: Objective Response Rate (ORR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | ORR:percentage of patients who had best overall response (BOR) with complete response (CR),CR with incomplete marrow recovery (CRi),nodular partial response (nPR) or PR for CLL patients; CR, very good PR(VGPR), PR or minor response(MR) for WM patients; CR or PR for patients with disease type other than CLL and WM. BOR:best response from start of treatment until progression or any further anticancer therapy.CR:absence of serum(S) monoclonal immunoglobulin (Ig)M, normal S IgM, complete resolution of extramedullary disease,morphologically normal bone marrow aspirate and trephine biopsy. CRi:criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR:patients with residual CLL cells. PR, VGPR, MR:detectable monoclonal IgM,no new signs/symptoms of active disease and PR:\>=50% but \<90% reduction in S IgM,reduction in extramedullary disease,VGPR: \>=90% reduction in S IgM, complete resolution of extramedullary disease, MR: \>=25% but \<50% reduction in S IgM. |
| Primary | Dose Expansion Stage: Complete Response Rate | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | CR rate was defined as the percentage of patients who had BOR with CR or CRi for CLL patients, and CR only for other patients. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. CR was defined as the absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi was defined as the criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. |
| Primary | Dose Expansion Stage: Clinical Benefit Rate (CBR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | CBR was defined as the percentage of patients who had BOR of stable disease (SD) or better. BOR was defined as the best response from start of treatment until progression or any further anticancer therapy. SD was defined as detectable monoclonal IgM, \<25% reduction and \<25% increase in serum IgM level, no progression in extramedullary disease, no new signs/symptoms of active disease. |
| Primary | Dose Expansion Stage: Duration of Response (DOR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | DOR: time from when first response (CR, CRi, PR, nPR, VGPR, PR-L, and MR) was achieved until earlier of first documentation of definitive PD or death from any cause. CR: absence of S monoclonal IgM, normal S IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR,MR:detectable monoclonal IgM,no new signs/symptoms of active disease and PR: \>=50% but \<90% reduction in S IgM,reduction in extramedullary disease,VGPR: \>=90% reduction in S IgM,complete resolution of extramedullary disease,MR: \>=25% but \<50% reduction in S IgM. PD: \>=25% increase in S IgM level from lowest nadir and/or progression in clinical features attributable to disease. |
| Primary | Dose Expansion Stage: Time to Response (TTR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | TTR was defined as the time from the first dose of study treatment to the first occurrence of CR, CRi, PR, nPR, VGPR, PR-L, or MR. CR: absence of serum monoclonal IgM, normal serum IgM, complete resolution of extramedullary disease, morphologically normal bone marrow aspirate and trephine biopsy. CRi: criteria fulfilled for CR but persistent cytopenia, anemia, thrombocytopenia or neutropenia. nPR: patients with residual CLL cells. PR-L: patients achieved PR with CLL-related signs/symptoms other than lymphocytosis and continued on therapy. PR, VGPR, MR: detectable monoclonal IgM, no new signs/symptoms of active disease and PR: \>=50% but \<90% reduction in serum IgM, reduction in extramedullary disease, VGPR: \>=90% reduction in serum IgM, complete resolution of extramedullary disease, MR: \>=25% but \<50% reduction in serum IgM. Kaplan Meier analysis included only the responders. |
| Primary | Dose Expansion Stage: Progression-Free Survival (PFS) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | PFS was defined as the time from the date of first study treatment to the earliest date of PD or death due to any reason whichever occurred first. PD was defined as \>=25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to disease. |
| Secondary | Dose Escalation Stage and Dose Expansion Stage: Maximum Plasma Concentration (Cmax) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1 | Blood samples were collected to determine Cmax of HMPL-523. The PK parameters were determined by non-compartmental analysis. Eventually, the patients discontinued as they progressed in the study. Hence, fewer patients at each cycle and no patients returned on Cycle 1 Day 28 in dose expansion stage: MZL arm. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days) | The DLT evaluable analysis set was defined as all patients enrolled in the dose escalation stage of the study who were evaluable for DLT assessment. A patient was DLT evaluable if: had received at least 75% of the assigned dose of study treatment during the DLT assessment window or had not completed the DLT assessment period due to a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation | From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 29 months | The FAS included all patients who received at least 1 dose of HMPL-523. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose Escalation Stage: Recommended Phase 2 Dose of HMPL-523 | From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (each cycle was 28 days) | The FAS included all patients who received at least 1 dose of HMPL-523. | mg | NUMBER |
| PRIMARY | Dose Expansion Stage: Objective Response Rate (ORR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The response evaluable set (RES) included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. | percentage of patients | NUMBER |
| PRIMARY | Dose Expansion Stage: Complete Response Rate | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. | percentage of patients | NUMBER |
| PRIMARY | Dose Expansion Stage: Clinical Benefit Rate (CBR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. | percentage of patients | NUMBER |
| PRIMARY | Dose Expansion Stage: Duration of Response (DOR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. Only patients with response of CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis. | months | MEDIAN |
| PRIMARY | Dose Expansion Stage: Time to Response (TTR) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The RES included all patients who received at least 1 dose of HMPL-523, had a baseline tumor measurement, and had at least 1 post-baseline tumor measurement or clinical restaging, unless death occurred before the first post-baseline assessment. Only patients with response of CR, CRi, PR, nPR, VGPR, PR-L, or MR were included in the analysis. | months | MEDIAN |
| PRIMARY | Dose Expansion Stage: Progression-Free Survival (PFS) | Tumor assessments performed every 8 weeks (+/-7 days) for the first 24 weeks and every 12 weeks (+/-7 days) thereafter until first progression, initiation of new anticancer therapy or death. Approximately 42 months | The FAS included all patients who received at least 1 dose of HMPL-523. | months | MEDIAN |
| SECONDARY | Dose Escalation Stage and Dose Expansion Stage: Maximum Plasma Concentration (Cmax) of HMPL-523 | Dose escalation: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1, 15 and 28 of Cycle 1; Dose expansion: Pre-dose and 0.5, 1, 2, 4, 6, 8 hours post-dose on Days 1 and 28 of Cycle 1 | PK analysis set (PKAS) included all patients who received at least 1 dose of HMPL-523 and had at least 1 PK sample obtained and analyzed. As pre-specified in statistical analysis plan (SAP), results are presented by disease groups and combined data for CLL and CLL-post BTK arms in dose expansion stage is presented for all patients evaluable for this endpoint who received HMPL-523 at RP2D (700 mg QD) in dose expansion stage. Only patients with data collected at specified timepoints are reported. | nanograms per milliliter (ng/mL) | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group395
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose Escalation Stage: HMPL-523 100 mg QD | 1 | Participants | ||
| Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose Escalation Stage: HMPL-523 200 mg QD | 0 | Participants | ||
| Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose Escalation Stage: HMPL-523 400 mg QD | 0 | Participants | ||
| Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose Escalation Stage: HMPL-523 600 mg QD | 0 | Participants | ||
| Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose Escalation Stage: HMPL-523 700 mg QD | 0 | Participants | ||
| Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose Escalation Stage: HMPL-523 800 mg QD | 2 | Participants | ||
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation | Dose Escalation Stage: HMPL-523 100 mg QD | Any TEAE | 4 | Participants | |
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation | Dose Escalation Stage: HMPL-523 200 mg QD | Any TEAE | 3 | Participants | |
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation | Dose Escalation Stage: HMPL-523 400 mg QD | Any TEAE | 3 | Participants | |
Dose Escalation Stage: Number of Patients With Treatment-Emergent Adverse Events, Treatment Related Treatment-Emergent Adverse Events, Treatment-Emergent Adverse Events Leading to Treatment Interruption, Treatment Reduction and Treatment Discontinuation | Dose Escalation Stage: HMPL-523 600 mg QD | Any TEAE | 3 | Participants |
1 to 10 of 395Source ClinicalTrials.gov
See all 395 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Stage: HMPL-523 100 mg QD | 4 | |
| Overall Study | STARTED | Dose Escalation Stage: HMPL-523 200 mg QD | 3 | |
| Overall Study | STARTED | Dose Escalation Stage: HMPL-523 400 mg QD | 3 | |
| Overall Study | STARTED | Dose Escalation Stage: HMPL-523 600 mg QD | 3 | |
| Overall Study | STARTED | Dose Escalation Stage: HMPL-523 700 mg QD | 4 | |
| Overall Study | STARTED | Dose Escalation Stage: HMPL-523 800 mg QD | 4 | |
| Overall Study | STARTED | Dose Expansion Stage: HL | 25 | |
| Overall Study | STARTED | Dose Expansion Stage: CLL | 1 | |
| Overall Study | STARTED | Dose Expansion Stage: CLL-post BTK | 7 | |
| Overall Study | STARTED | Dose Expansion Stage: FL | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,652
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Dose Escalation Stage: HMPL-523 100 mg QD | 0 | 4 | 0 |
| other | Pyrexia | General disorders | Dose Escalation Stage: HMPL-523 200 mg QD | 0 | 3 | 0 |
| other | Pyrexia | General disorders | Dose Escalation Stage: HMPL-523 400 mg QD | 1 | 3 | 1 |
| other | Pyrexia | General disorders | Dose Escalation Stage: HMPL-523 600 mg QD | 2 | 3 | 2 |
| other | Pyrexia | General disorders | Dose Escalation Stage: HMPL-523 700 mg QD | 0 | 4 | 0 |
| other | Pyrexia | General disorders | Dose Escalation Stage: HMPL-523 800 mg QD | 2 | 4 | 2 |
| other | Pyrexia | General disorders | Dose Expansion Stage: HL | 4 | 25 | 6 |
| other | Pyrexia | General disorders | Dose Expansion Stage: CLL | 0 | 1 | 0 |
| other | Pyrexia | General disorders | Dose Expansion Stage: CLL-post BTK | 3 | 7 | 4 |
| other | Pyrexia | General disorders | Dose Expansion Stage: FL | 0 | 2 | 0 |
1 to 10 of 1,652Source ClinicalTrials.gov
See all 1,652 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Stage: HMPL-523 100 mg QD | 0 | 4 |
| Total, all-cause mortality | Dose Escalation Stage: HMPL-523 200 mg QD | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Stage: HMPL-523 400 mg QD | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Stage: HMPL-523 600 mg QD | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Stage: HMPL-523 700 mg QD | 0 | 4 |
| Total, all-cause mortality | Dose Escalation Stage: HMPL-523 800 mg QD | 1 | 4 |
| Total, all-cause mortality | Dose Expansion Stage: HL | 2 | 25 |
| Total, all-cause mortality | Dose Expansion Stage: CLL | 0 | 1 |
| Total, all-cause mortality | Dose Expansion Stage: CLL-post BTK | 1 | 7 |
| Total, all-cause mortality | Dose Expansion Stage: FL | 0 | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42782312 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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