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SGR-3515

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Schrodinger, Inc.|Trials Updated: Aug 1, 2025

SGR-3515 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

SGR-3515 clinical trials

SGR-3515 · 1 trial · 1 indication

Phase 1 1
NCT06463340Study of SGR-3515 In Participants With Advanced Solid Tumors.Advanced Solid Tumor
RECRUITING52 Analytics
PHASE1RECRUITING
Study of SGR-3515 In Participants With Advanced Solid Tumors.
Advanced Solid Tumor
NCT0646334052
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Study Endpoints

Primary Endpoints

Incidence and severity of adverse events (AEs)
Day 1 to 28 days after the last dose of SGR-3515.

Incidence and severity of adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs); and dose interruptions, dose reductions, dose delays and study drug discontinuation due to AEs.

Incidence of Dose Limiting Toxicities (DLTs)
Day 1 to Day 28 of the first 28-day dosing cycle.
Incidence of serious adverse events (SAEs)
Day 1 to 28 days after the last dose of SGR-3515
Recommended phase 2 dose and schedule
From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.

Secondary Endpoints

Pharmacokinetics: Measures Cmax and Cmin of SGR-3515
Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: t1/2 of SGR-3515
Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: tmax of SGR-3515
Day 1 to Day 28 of first 28-day dosing cycle
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTAL28-day treatment cycle.

Interventions

NameTypeDescription
SGR-3515DRUGSGR-3515 will be administered orally with an intermittent schedule.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

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/proced...

Countries:United StatesCanada
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK3PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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