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The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors


Active: Yes
Cancer Type: Solid Tumor
Unknown Primary
NCT ID: NCT04768868
Trial Phases: Phase I Protocol IDs: IMP7068 - 101 (primary)
NCI-2021-13607
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Impact Therapeutics, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT04768868

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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.