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Monoclonal Antibodies

IMP7068 for Solid Tumors (WEE1 Trial)

Phase 1

Recruiting

Research Sponsored by Impact Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -7 to repeat dose day 1; postdose at multiple time points from day 1 to day 21 in cycle 1 (cycle 1 = 21 days), day 1 on cycle 2 (cycle 2 onwards = 21 day-cycles) and subsequent cycles (up to 26 months)

Awards & highlights

WEE1 Trial Summary

This trial is testing a new drug to see if it is effective and safe in treating advanced solid tumors.

Eligible Conditions

Advanced Solid Tumors

WEE1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -7 to repeat dose day 1; postdose at multiple time points from day 1 to day 21 in cycle 1 (cycle 1 = 21 days), day 1 on cycle 2 (cycle 2 onwards = 21 day-cycles) and subsequent cycles (up to 26 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -7 to repeat dose day 1; postdose at multiple time points from day 1 to day 21 in cycle 1 (cycle 1 = 21 days), day 1 on cycle 2 (cycle 2 onwards = 21 day-cycles) and subsequent cycles (up to 26 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -7 to repeat dose day 1; postdose at multiple time points from day 1 to day 21 in cycle 1 (cycle 1 = 21 days), day 1 on cycle 2 (cycle 2 onwards = 21 day-cycles) and subsequent cycles (up to 26 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 Dose Escalation: Incidence of treatment emergent adverse events (TEAEs)

Part 1 Dose Escalation: Recommended Phase 2 Dose (RP2D) of IMP7068 monotherapy

Part 1 Dose Escalation: Severity of treatment emergent adverse events (TEAEs), according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0

+1 more

Secondary outcome measures

Disease

Part 1 Dose Escalation: Duration of response (DOR): duration of time a patient is evaluated as either complete response (CR) or partial response (PR) as best response until the first date that the criteria for progression are met, or death.

Part 1 Dose Escalation: Objective response rate (ORR): percentage of patients who had a best response

+7 more

WEE1 Trial Design

1Treatment groups

Experimental Treatment

Group I: IMP7068Experimental Treatment1 Intervention

Part 1: Dose Escalation The study will begin with open-label dose escalation in IMP7068 monotherapy treatment to determine the Maximum tolerated dose (MTD) Part 2: Dose Expansion The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage. A total of 100 patients each with advanced solid tumor who has exhausted available treatment options will be evaluated.

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Who is running the clinical trial?

CovanceIndustry Sponsor

119 Previous Clinical Trials

12,468 Total Patients Enrolled

Impact Therapeutics, Inc.Lead Sponsor

14 Previous Clinical Trials

1,254 Total Patients Enrolled

~82 spots leftby Jun 2025

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