An Open-Label Study of GV20-0251 in Patients with Advanced and/or Refractory Solid Tumor Malignancies

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Part A

Primary Objectives:

To characterize the safety and tolerability of GV20-0251 and establish the MTD and/or the RP2D of GV20-0251

Secondary Objectives:

Part B

Primary Objectives:

To evaluate the ORR per RECIST version 1.1 of GV20-0251 in different tumor types

Secondary Objectives:

Eligibility

Inclusion Criteria:

>= 18 years of age
Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy
Refractory or intolerant to standard therapy(ies)
Must have received, be not eligible or decline standard of care therapy
One or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1
For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
ECOG performance status of 0 or 1
Life expectancy of >=12 weeks
Disease-free of active second/secondary or prior malignancies for ≥ 2 years
Laboratory test results within the required parameters
Women of child bearing potential (WOCBP) and men must agree to use adequate contraception
Part B ONLY must include the following tumor types:

Exclusion Criteria:

Participant with acute luekemia or CLL
Participant with heart disease or unstable arrhythmia
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
History of major organ transplant
History of a bone marrow transplant
Symptomatic central nervous system (CNS) malignancy or metastasis
Serious nonmalignant disease
Pregnant or nursing women
Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication
Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication
Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication
Radiation for symptomatic lesions must have been completed prior to the first dose of study medication
Active substance abuse

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices