A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 (formerly MGA012) in Patients with Advanced Solid Tumors

  • STATUS
    Recruiting
Updated on 14 December 2020
cancer
measurable disease
primary cancer
endometrial carcinoma

Summary

This study is a Phase 1, open-label, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary anti-tumor activity of INCMGA00012 administered IV every two or four weeks in patients with relapsed/refractory, unresectable locally advanced or metastatic solid tumors. 

The study consists of two phases, a Dose Escalation Phase (which has been completed) followed by a Cohort Expansion Phase.

The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

 

Description

Study is fully recruited except for MSI high or dMMR endometrial cancer

Details
Condition Cancer/Tumors, Endometrial Cancer
Clinical Study IdentifierTX218019
Last Modified on14 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined. Patients enrolled to Cohort H (endometrial cancer 500 mg Q4W) must have MSI-H or dMMR endometrial cancer, as determined by a local laboratory using IHC or PCR methods and must also have tissue (fresh or archival) available for central confirmation of diagnosis
Expansion cohort(s): Progression during or following at least 1, and up to 5, previous systemic therapies, consistent with the standard of care for the specific tumor type
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy ≥ 12 weeks
Measurable disease
Acceptable laboratory parameters

Exclusion Criteria

Symptomatic central nervous system (CNS) metastases
For Cohort Expansion, patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) are not eligible for this study
Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing
Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 4 weeks prior to the initiation of study drug administration
Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration
Clinically significant cardiovascular disease
Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
Presence of active pneumonitis or history of non-infectious pneumonitis
Clinically significant gastrointestinal disorders
Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug
Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR)
Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed
Dementia or altered mental status that would preclude understanding and rendering of informed consent
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