The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
IMP7068 - 101 (primary)
NCI-2021-13607
Summary
A Phase 1 Dose Escalation and Expansion Study of IMP7068 Monotherapy in Advanced Solid
Tumors
Objectives
This is A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study to
Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of the WEE1
Inhibitor IMP7068 Monotherapy in Patients with Advanced Solid Tumors
The study will include a dose-escalation stage and a dose-expansion stage. The
dose-escalation stage is designed to determine the maximum tolerated dose (MTD) and
select recommended Phase 2 dose (RP2D) of IMP7068 monotherapy. The dose-expansion stage
will be conducted with RP2D to further evaluate the preliminary anti-tumor activity,
safety and tolerability.
A total of approximately 140-350 patients will be enrolled in the study.
Approximately 60-100 patients will be enrolled into Part 1 dose escalation of IMP7068
monotherapy. A total of 100 patients each with advanced solid tumor will be evaluated in
Part 2 dose-expansion of IMP7068 monotherapy.
Eligibility
- The patient must voluntarily participate in this clinical study. Be willing and able to provide written informed consent form (ICF) prior to any study activity.
- Age =18 years on the day of signing the ICF, males or females. Only for Korea, Age =19 years on the day of signing the ICF.
- The enrolled patients must have histologically or cytologically confirmed advanced solid tumor that is refractory/intolerant to standard treatment or for which no standard treatment exists. The patients with known microsatellite-instability high (MSI-H) or deficient in mismatch repair (dMMR) disease are required to have received prior PD 1/PD-L1 therapy; those with known NTRK fusion are required to have received an approved TRK-inhibitor. The patients who are suitable for resection or other localized therapy that is potentially curative are not eligible. Key
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