A Study to Evaluate the Safety and Tolerability of HMPL-306 to Treat Advanced or Metastatic Solid Tumors with IDH Mutations

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, and preliminary effectiveness of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

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

- Subjects aged ≥18 years.

- ECOG performance status 0 or 1

- Subjects must have a documented IDH mutation per immunohistochemistry (IHC),
polymerase chain reaction (PCR), or next generation sequencing (NGS) testing of tumor
tissue.

- Subjects must have histologically or cytologically documented, advanced or metastatic
solid malignancy of any type that has recurred or progressed on available standard
treatment and for which no curative therapy exists.

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

Eligibility last updated 8/17/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sani Kizilbash, M.D., M.P.H.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20533343

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