First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors

Study Identifier:
GCT1047-01
CT.gov Identifier:
NCT05180474
EudraCT Identifier:
2021-001790-23
EU Trial (CTIS) Number:
2024-510722-10-00
Study Contact Information:
N/A
Terminated/Withdrawn

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Study Summary

To evaluate safety of GEN1047 in subjects with malignant solid tumors

T evaluate safety. Besides safety, the study will determine the recommended GEN1047 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1047.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
  • Endometrial
  • Ovarian
  • Non-Small Cell Lung Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Treatment
    • Read More
  • Drug: he trial consists of two parts: a dose escalation part ("escalation" - phase 1) and an expansion part ("expansion" - phase 2a). The goal of the dose escalation part is to find out if GEN1047 is safe in patients with specific solid tumors and to find the best dose. The best dose is the so-called Recommended Phase 2 Dose (RP2D). The expansion part of the trial (phase 2a) will be initiated once the RP2D has been determined from phase 1.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    Inclusion criteria
    • Criteria - Escalation Part:
    • Participant must have histologically or cytologically confirmed solid tumor(s) in any of the following selected indications for which there is no further available standard therapy likely to confer clinical benefit (or participant is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with GEN1047 may be beneficial (breast cancer, endometrial cancer, ovarian cancer, NSCLC-SCC.
    • Participants with ovarian cancer must have documented progressive disease (PD) on or after last prior treatment and within 60 days of screening.
    • Must be at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) on the day of signing informed consent.
    • Must have either recurrence after, or progression on or lack of response to available relevant standard of care (SoC) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting.
    • Must have at least 1 measurable lesion per RECIST v1.1. The measurable lesion(s) must be outside the field of radiation therapy (RT) if there was prior treatment with RT.
    • Must have an Eastern Cooperative Oncology Group performance status (ECOGPS) score of 0 to 1 at Screening and on C1D1 pretreatment.
    • Should provide a tumor tissue sample during the Screening period and prior to C1D1.
    • Provide all tumor-assessing pre-trial CT scans since failure of last prior therapy.
    • Criteria - Expansion Part Stage 1, 1b and Stage 2:
    • Participants must have documented PD according to RECIST v1.1 on or after last prior treatment with latest scan performed a maximum of 28 days prior to the first dose.
    • Participant must have advanced (unresectable) or metastatic, histologically confirmed diagnosis (breast cancer, endometrial cancer, ovarian cancer.
    Exclusion criteria
    • Significant cardiovascular impairment within 6 months of the first dose of trial drug.
    • Participant with new or progressive brain metastases or spinal cord compression.
    • Participant has been exposed to any prior therapy with a compound targeting CD3 and/or B7H4 or cell based therapies.
    • Current pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of non-infectious drug-, immune-, or radiation-related pneumonitis that required steroid.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Breast Cancers
    Endometrial
    Ovarian
    Non-Small Cell Lung Cancer