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SGR-3515 for Advanced Cancer

Phase 1
Recruiting
Research Sponsored by Schrödinger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of advanced/metastatic solid tumor
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Participants with primary Central Nervous System (CNS tumors)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 28 days after the last dose of sgr-3515.
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to understand how a new drug, SGR-3515, can potentially help treat advanced solid tumors."

Who is the study for?
This trial is for adults with advanced solid tumors that can be measured, who are fairly active (can care for themselves), and have good organ function. Women able to have children and men must agree to use effective birth control during the study and for 3 months after.
What is being tested?
The trial is testing SGR-3515, a new potential treatment for people with advanced solid tumors. It aims to understand how well this drug works and its safety profile in participants.
What are the potential side effects?
Potential side effects of SGR-3515 aren't specified here but may include typical reactions seen with cancer treatments such as fatigue, nausea, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread to other parts of my body.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer originated in the brain or spinal cord.
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I have recovered from previous cancer treatment side effects, except for hair loss, nerve pain, or hearing loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 28 days after the last dose of sgr-3515
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 28 days after the last dose of sgr-3515 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of adverse events (AEs)
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of serious adverse events (SAEs)
+1 more
Secondary study objectives
Efficacy analysis
Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515
Pharmacokinetics Measures: t1/2 of SGR-3515
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment1 Intervention
28-day treatment cycle.

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Who is running the clinical trial?

Schrödinger, Inc.Lead Sponsor
2 Previous Clinical Trials
102 Total Patients Enrolled
Margaret Dugan, MDStudy DirectorCMO/Study Physician
~35 spots leftby Oct 2026
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