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Small Molecule Inhibitor

HMPL-523 for Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Hutchison Medipharma Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with relapsed or refractory lymphoma who have exhausted all approved therapy options

ECOG performance status of 0 or 1

Must not have

Current use of medication known to cause QT prolongation or Torsades de Pointes

Prior treatment with any spleen tyrosine kinase (SYK) inhibitors (eg, fostamatinib)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cycle 1, day 1, 5 min pre-dose 1st dose until cycle 1, day 28 8 hours post-dose.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for people with lymphoma who have run out of other options. The first part is to see what dose is safe, and the second part is to see if it works.

Who is the study for?

Adults over 18 with lymphoma that's come back or hasn't responded to treatment can join this trial. They should be relatively healthy (ECOG status of 0 or 1), have a life expectancy over 24 weeks, and agree to use effective birth control. People with certain blood counts, organ dysfunction, recent other treatments, or serious health issues like heart failure aren't eligible.

What is being tested?

The trial is testing HMPL-523, an oral medication for patients with relapsed/refractory lymphoma. It has two parts: first finding the right dose (Stage 1) and then seeing how well it works at that dose in more people (Stage 2).

What are the potential side effects?

Possible side effects are not detailed here but may include typical reactions from cancer drugs such as fatigue, digestive issues, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will be monitored closely due to the investigational nature of HMPL-523.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma has returned or didn't respond to treatment, and I've tried all approved treatments.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication that affects my heart's rhythm.

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I have not taken any SYK inhibitor medications.

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I have previously received a cancer vaccine.

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My heart's electrical system has a condition or my QT interval is longer than normal.

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I haven't taken strong medication that affects liver enzymes recently.

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I have not had major surgery in the last 4 weeks.

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I do not have any serious infections like pneumonia.

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My side effects from cancer treatment are mild, except for hair loss.

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I cannot take pills by mouth or have issues absorbing medication.

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I do not have a significant history of liver disease, alcohol abuse, or active HIV, hepatitis B or C infections.

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My liver, kidney, and blood clotting functions are not within normal ranges.

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I haven't had a stem cell transplant in the last 6 months and don't have active graft versus host disease.

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I had a stem cell transplant using my own cells within the last 6 months.

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I have moderate to severe heart failure.

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I have been diagnosed with lymphoma in my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from cycle 1, day 1, 5 min pre-dose 1st dose until cycle 1, day 28 8 hours post-dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from cycle 1, day 1, 5 min pre-dose 1st dose until cycle 1, day 28 8 hours post-dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1, day 1, 5 min pre-dose 1st dose until cycle 1, day 28 8 hours post-dose. for reporting.