MGC018 With or Without MGA012 in Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    May 12, 2023
  • participants needed
    182
  • sponsor
    MacroGenics
Updated on 12 March 2022
cancer
systemic therapy
measurable disease
hormone therapy
chemotherapy regimen
pd-l1
cancer chemotherapy
solid tumour
mgc018

Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGC018 administered alone and in combination with MGA012 in patients with advanced solid tumors.

Description

This Phase 1/2 study will characterize safety, dose-limiting toxicities (DLTs), and maximum tolerated/administered dose (MTD/MAD) and anti-tumor activity for MGC018 as monotherapy (Module A) in patients with advanced solid tumors. Each module consists of a Dose Escalation (3+3+3 design) followed by a Cohort Expansion Phase. Patients with solid tumors will be enrolled in the Dose Escalation Phase; Cohort Expansion will include metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), squamous cell carcinoma of the head and neck (SCCHN), and melanoma. Patients who do not experience unacceptable toxicity or meet criteria for permanent discontinuation may undergo additional cycles for up to two years. Patients in Cohort Expansion will be followed for survival every 3 months for 2 years following last dose.

Module B, MGC018 in combination with retifanlimab, Dose Escalation and Cohort Expansion will commence only upon sponsor notification to all study investigators.

Details
Condition Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Cancer, Melanoma, Advanced Solid Tumor, Adult, Metastatic Castrate Resistant Prostate Cancer, Non Small Cell Lung Cancer
Treatment MGA012, MGC018, Retifanlimab
Clinical Study IdentifierNCT03729596
SponsorMacroGenics
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Tissue specimen available for retrospective analysis of B7-H3 and PD-L1 expression
Eastern Cooperative Oncology Group performance status of ≤2
Life expectancy ≥ 12 weeks for dose escalation phase and ≥ 24 weeks for cohort expansion phase
Measurable disease. Prostate cancer patients with bone only disease are eligible
Acceptable laboratory parameters and adequate organ reserve
Dose Escalation Phase: Patients with histologically proven, unresectable, locally advanced or metastatic solid tumors for whom no therapy with demonstrated clinical benefit is available
Module A Cohort Expansion
mCRPC that has progressed with one prior line of chemotherapy for metastatic disease and no more than two prior lines of anti-hormonal therapy
NSCLC: metastatic disease after standard cytotoxic, targeted, and biologic or checkpoint inhibitor therapy. No more than 2 prior lines of chemotherapy
TNBC: Locally advance or metastatic disease that has progressed following at least one systemic therapy
SCCHN that has progressed during or following at least one systemic therapy for metastatic or recurrent unresectable disease. No more than 2 prior lines of chemotherapy
Melanoma that has progressed during or following at least one systemic treatment for unresectable locally advanced or metastatic disease. Patients who are intolerant of or refused standard therapy are eligible

Exclusion Criteria

Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on MRI, CT or PET within 6 months, or history of leptomeningeal disease or cord compression at the time of enrollment
Prior treatment with B7-H3 targeted agents for cancer
Treatment with systemic cancer therapy, biologic agents, or anti-hormonal therapy (mCRPC) within 4 weeks, prior small molecule targeted or kinase inhibitors within 14 days or 5 half-lives, prior radioligand within 6 months
Clinically significant cardiovascular disease
Clinically significant pulmonary compromise or requirement for supplemental oxygen
Active viral (including confirmed or presumed COVID-19), bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction
History of clinically-significant cardiovascular disease, including but not limited to pericarditis or pericardial effusion
Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
Major trauma or major surgery within 4 weeks of first study drug administration
Clinically significant venous insufficiency
Evidence of pleural effusion
Evidence of ascites
> Grade 1 peripheral neuropathy
Serum testosterone >50 ng/dl or >1.7 nmol/L in mCRPC in Module A Cohort Expansion Phase
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