A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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 mutations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited

Criteria

Key Inclusion Criteria:

Subjects may be enrolled in this study only if they satisfy all the following criteria (NOTE: This is not an exhaustive list):

• Subjects aged ≥18 years.

• ECOG performance status ≤ 2

• Subjects with advanced relapsed, refractory, or resistant hematological malignancies, as defined below:

• Subjects with documented IDH mutation per local or institutional next generation sequence (NGS).

• Subjects must be refractory to or intolerant of established therapies

Key Exclusion Criteria:

Subjects are not eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list):

• Subjects who received an investigational agent <14 days prior to their first day of study drug administration

• Subjects who are pregnant or breastfeeding

• Subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever >38.3°C during screening visits or on their first day of study drug administration.

• Subjects with some current or prior heart conditions

• Subjects taking medications that are known to prolong the QT interval may not be eligible

• Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation

• Some subjects with some current or prior gastrointestinal or liver diseases

• Subjects with inadequate organ function as defined by the protocol