Study of SGR-3515 In Participants With Advanced Solid Tumors.
Study of SGR-3515 In Participants With Advanced Solid Tumors.
The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced solid tumors.
Not Available
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
Not Available
Gibson, Mike
International
Vanderbilt University
03-17-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Diagnosis of advanced/metastatic solid tumor
Diagnosis of advanced/metastatic solid tumor
Measurable disease per RECIST version 1.1
Measurable disease per RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
Adequate bone marrow and organ function
Adequate bone marrow and organ function
Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug
Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug
Exclusion Criteria:
Participants with primary Central Nervous System (CNS tumors).
Participants with primary Central Nervous System (CNS tumors).
Participant has received prior systemic anti-cancer treatments or other investigational agents 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
Participant has received prior systemic anti-cancer treatments or other investigational agents 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
Participant who has received definitive local control radiation (any dose greater than 50 Gy) 42 days prior to the first dose of study drug.
Participant who has received definitive local control radiation (any dose greater than 50 Gy) 42 days prior to the first dose of study drug.
Participant who has received major surgeries 21 days prior to first dose of study drug
Participant who has received major surgeries 21 days prior to first dose of study drug
Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
Participant who has another clinically significant invasive malignancy, as determined by the investigator, 2 years prior to the first dose
Participant who has another clinically significant invasive malignancy, as determined by the investigator, 2 years prior to the first dose
Diagnosis of advanced/metastatic solid tumor
Diagnosis of advanced/metastatic solid tumor
Measurable disease per RECIST version 1.1
Measurable disease per RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
Adequate bone marrow and organ function
Adequate bone marrow and organ function
Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug
Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug
Exclusion Criteria:
Participants with primary Central Nervous System (CNS tumors).
Participants with primary Central Nervous System (CNS tumors).
Participant has received prior systemic anti-cancer treatments or other investigational agents 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
Participant has received prior systemic anti-cancer treatments or other investigational agents 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
Participant who has received definitive local control radiation (any dose greater than 50 Gy) 42 days prior to the first dose of study drug.
Participant who has received definitive local control radiation (any dose greater than 50 Gy) 42 days prior to the first dose of study drug.
Participant who has received major surgeries 21 days prior to first dose of study drug
Participant who has received major surgeries 21 days prior to first dose of study drug
Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
Participant who has another clinically significant invasive malignancy, as determined by the investigator, 2 years prior to the first dose
Participant who has another clinically significant invasive malignancy, as determined by the investigator, 2 years prior to the first dose
