Study of SGR-3515 In Participants With Advanced Solid Tumors.

ID#: NCT06463340

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: June 18, 2024

End Date: December 31, 2026

Contact Information:
Study Physician
+15032991150
Summary: 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.
Eligibility:

Inclusion Criteria:

- Diagnosis of advanced/metastatic solid tumor

- Measurable disease per RECIST version 1.1

- 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

- 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 Exclusion Criteria

- 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 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

- 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