First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors

Phase 2

• Conditions: breast, uterine, ovarian and squamous non-small cell lung cancer (NSCLC-SCC); cancer; Solid tumor

• Registration Number: NL-OMON56075
• Lead Sponsor: Genmab

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Criteria - Escalation Part:
• Subject 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 subject 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, squamous
non-small-cell lung cancer [NSCLC-SCC]).
• Subjects 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:
• Subjects 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.
• Subject must have advanced (unresectable) or metastatic, histologically
confirmed diagnosis (breast cancer, endometrial cancer, ovarian cancer,
squamous non-small cell lung cancer [NSCLC-SCC]).
• Must be a female and at least 18 years of age (or the legal age of consent in
the jurisdiction in which the trial is taking place) at the time of consent.
• Must have at least 1 measurable lesion per RECIST v1.1 as assessed by local
investigator.
• Must have an ECOG- PS score of 0 to 1 at Screening and on Cycle 1 Day 1
(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.

Exclusion Criteria

• Significant cardiovascular impairment within 6 months of the first dose of
trial drug.
• Subject with new or progressive brain metastases or spinal cord compression.
• Subject has a history of bowel obstruction related to underlying disease.
• Subject 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified