Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below

Back to Results

A First-In-Human, Phase 1, Dose-Escalation Study of SGR-3515 In Participants with Advanced Solid Tumors

Cancer Categories

Lung

Karmanos Trial ID

2024-098

NCT ID

NCT06463340

Age Group

Adult

Scope

National

Phase

Phase I

Principal Investigator

Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

Objective:

Primary Objectives:

Evaluate SGR-3515 safety, tolerability, dose-limiting toxicities (DLTs) in participants with advanced solid tumors
Identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) and recommended schedule (RP2S) of SGR-3515

Secondary Objectives:

Evaluate SGR-3515 PK in participants with advanced solid tumors
Evaluate SGR-3515 preliminary anti-tumor activity in participants with advanced solid tumors as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or the applicable disease specific criteria

Request an Appointment

Refer a Patient

NCI Dictionary of Cancer Terms

KCI Clinical Trials App

Eligibility

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.

Locations

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
Get Directions

Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions

Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices