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A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations

Sponsored by Hutchmed

About this trial

Last updated 8 months ago

Study ID

2020-306-GLOB2

Status

Active, not recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.

What are the Participation Requirements?

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

Locations

Location

Status