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

Status
Active
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04768868
Protocol IDs
IMP7068 - 101 (primary)
NCI-2021-13607
Study Sponsor
Impact Therapeutics

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

  1. 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.
  2. 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.
  3. 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.
**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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.