An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Patients With Relapsed or Refractory Lymphoma

ClinicalTrials.gov ID

NCT03779113

Acronym / sponsor ID

2018-523-00US1

Conditions

Non Hodgkin Lymphoma

Keywords

lymphoma, chronic lymphocytic leukemia, Hodgkin lymphoma

Phase

Phase 1

Study type

Interventional

Recruitment status

TerminatedReason stopped: Study terminated by sponsor

Enrolment

69 participants (actual)

Lead sponsor

HutchmedIndustry (pharma, biotech, devices)

Study start

26 Sep 2019 (actual)

Primary completion

26 Feb 2025 (actual)

Study completion

26 Feb 2025 (actual)

First posted

19 Dec 2018 (actual)

Results

Posted 18 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Dose Escalation Stage: Number of Patients With Dose-Limiting Toxicities (DLTs)

   Time frame: 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.

2. 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

   Time frame: 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.

3. Dose Escalation Stage: Recommended Phase 2 Dose of HMPL-523

   Time frame: 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.

4. Dose Expansion Stage: Objective Response Rate (ORR)

   Time frame: 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.

5. Dose Expansion Stage: Complete Response Rate

   Time frame: 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.

6. Dose Expansion Stage: Clinical Benefit Rate (CBR)

   Time frame: 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.

7. Dose Expansion Stage: Duration of Response (DOR)

   Time frame: 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.

8. Dose Expansion Stage: Time to Response (TTR)

   Time frame: 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.

9. Dose Expansion Stage: Progression-Free Survival (PFS)

   Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 42782312Strati P, Chraniuk D, Gonzalez Barca E, Ahmed S, Chien C, Bongiovanni D, Nanda S, Schelman W. Phase 1, open-label, multicenter study of sovleplenib (HMPL-523) in patients with relapsed or refractory lymphoma. Blood Adv. 2026 Sep 24:bloodadvances.2026021214. doi: 10.1182/bloodadvances.2026021214. Online ahead of print.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

32 sites in 7 countries: see every site and its status.