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.

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