GEN1046 in Combination with Anticancer Agents for the Treatment of Advanced Endometrial Cancer
A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination with Anticancer Agents in Subjects with Advanced Endometrial Cancer
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Clinical Trial Information
Trial Contact: Durand, Jennifer; Ribacchi, Stephanie
Trial Phone: 321.843.2026 ; 321-841-1077
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IRB No: 20231552
Protocol Abbrev: GCT1046-05
Principal Investigator: Shelly Marie Seward, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: GCT1046-05
ClinicalTrials.gov ID: Pending
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Objective
Evaluate the antitumor activity of GEN1046 in combination with anticancer therapy in subjects with advanced endometrial cancer.
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Key Eligibility
Key Inclusion Criteria:
• Have a histologically confirmed diagnosis of advanced (unresectable, recurrent, and/or metastatic) endometrial carcinoma that is incurable and for which prior standard first-line treatment has failed.
a) Note: Sarcomas, carcinosarcoma, and mesenchymal endometrial cancer are excluded.
• Prior to C1D1, documentation of tumor dMMR/MSI-H status must be available based on previously performed mismatch repair (MMR)/microsatellite instability (MSI) testing results using immunohistochemistry (IHC), polymerase chain reaction (PCR), or next-generation sequencing (NGS) performed with a Food and Drug Administration (FDA)-approved/Conformitè Europëenne (CE)-marked test.
• Must have progressed on or after at least 1 (but no more than 2) prior line(s) of a systemic chemotherapy regimen for unresectable and/or metastatic endometrial cancer of which at least 1 regimen of platinum-based treatment unless subject is ineligible for or intolerant to platinum.
a) Note: Subjects may have received up to 1 additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting.
b) Note: Neoadjuvant and adjuvant chemotherapy count as first lines of prior systemic therapy if there is documented disease progression within 6 months of chemotherapy completion.
c) Note: Prior hormonal therapy does not count against the number of prior lines and is not restricted up to 7 days prior to C1D1.
• Cohort A only: Must be treatment naive for CPIs including PD-1 or PD-L1 inhibitors and other immuneCPIs (eg, anticytotoxic T-lymphocyte-associated protein 4 [CTLA-4], anti-lymphocyte-activation gene 3 [LAG3], anti-T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains [TIGIT]).
• Cohort B only: Must have received and progressed on or after prior treatment with a PD-1/PD-L1inhibitor alone or in combination. Moreover, the subject must fulfill the following:
• Duration of CPI containing treatment and best overall response (BOR) is known, and subject has received a minimum of 2 cycles of CPI.
