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About
A phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.
Full description
This is a phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 (eprenetapopt) in combination with pembrolizumab in subjects with solid tumor malignancies. In the safety lead-in part of study (phase 1), the safety and the recommended phase 2 dose (RP2D) of APR-246 will be investigated.
In the expansion part of the study (phase 2), both safety and efficacy for the combination therapy will be investigated in the 3 cohorts.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent form (ICF) and ability to comply with protocol requirements.
Known tumor TP53 mutation status from recent or archival sample.
Histologically and/or cytologically confirmed solid tumor malignancy
Adequate organ function
Projected life expectancy of ≥ 12 weeks.
Age ≥ 18 years at the time of signing the ICF.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
In the expansion portion, measurable disease meeting the following criteria:
Negative serum or urine pregnancy test prior to study treatment initiation in female subjects of childbearing potential.
Women of childbearing potential and men with female partners of childbearing potential must be willing to use an effective form of contraception
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
37 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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