Advanced Solid TumorPhase 1NCT06463340
Study of SGR-3515 In Participants With Advanced Solid Tumors.
A Phase 1 study testing SGR-3515 in people with Advanced Solid Tumor, run by Schrödinger, Inc. at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SGR-3515
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 18 Jun 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 2 countries
United States13 sites, 13 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Jean Siedel, DO
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Robert W Naumann, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Pedro de Viveiros, MD
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Amanda Jackson, MD
- Recruiting
Ohio State University
Columbus, Ohio, 43210
John Hays, MD
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75235
David Miller, MD
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Ira Winer, MD
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Mohamad A Salkeni, MD
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vivek Subbiah, MD
- Recruiting
Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Michael K Gibson, MD
- Recruiting
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520
Patricia LoRusso, DO
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Deborah Doroshow, MD
- Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Kathleen N Moore, MD
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, MSG 1X6
Stephanie Lheureux, MD
About this study
Official title: A First-In-Human, Phase 1, Dose Escalation 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.
Read the detailed description
SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1/Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.
- Conditions
- Advanced Solid Tumor
- Being tested
- SGR-3515
- Keywords
- Solid Tumor, Advanced Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGR-3515Drug
SGR-3515 will be administered orally with an intermittent schedule.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 28-day treatment cycle. Receives: Drug: SGR-3515 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
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.
Measured: Day 1 to 28 days after the last dose of SGR-3515.
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of Dose Limiting Toxicities (DLTs)
Measured: Day 1 to Day 28 of the first 28-day dosing cycle.
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs)
Measured: Day 1 to 28 days after the last dose of SGR-3515
Recommended phase 2 dose and schedule
Recommended phase 2 dose and schedule
Measured: From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.
Secondary outcomes (5)
Pharmacokinetics: Measures Cmax and Cmin of SGR-3515
Pharmacokinetics: Cmax and Cmin of SGR-3515
Measured: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: t1/2 of SGR-3515
Pharmacokinetics: t1/2 of SGR-3515
Measured: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: tmax of SGR-3515
Pharmacokinetics: tmax of SGR-3515
Measured: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515
Pharmacokinetics: Area Under the Curve (AUC) of SGR-3515
Measured: Day 1 to Day 28 of first 28-day dosing cycle
Efficacy analysis
Efficacy analysis will be performed for each dose level and include but not limited to objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and duration of disease control (DDC), which will be assessed by investigators
Measured: Day 1 to end of Phase I study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start18 Jun 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schrödinger, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret Dugan, MD, Study director, CMO/Study Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463340
- Sponsor's protocol ID
- SGR-3515-101
- Status last verified
- Jul 2025
- First submitted
- 24 May 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06463340
- Acronym / sponsor ID
- SGR-3515-101
- Conditions
- Advanced Solid Tumor
- Keywords
- Solid Tumor, Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Schrödinger, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1/Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: SGR-351528-day treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGR-3515SGR-3515 will be administered orally with an intermittent schedule. | Drug | Dose Escalation |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: 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)
Time frame: Day 1 to Day 28 of the first 28-day dosing cycle.
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of serious adverse events (SAEs)
Time frame: Day 1 to 28 days after the last dose of SGR-3515
Incidence of serious adverse events (SAEs)
Recommended phase 2 dose and schedule
Time frame: From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.
Recommended phase 2 dose and schedule
5 secondary outcomes
Pharmacokinetics: Measures Cmax and Cmin of SGR-3515
Time frame: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: t1/2 of SGR-3515
Time frame: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: tmax of SGR-3515
Time frame: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515
Time frame: Day 1 to Day 28 of first 28-day dosing cycle
Efficacy analysis
Time frame: Day 1 to end of Phase I study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret Dugan, MD study director
CMO/Study Physician
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGR-3515 in people with Advanced Solid Tumor, run by Schrödinger, Inc. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Physician (+15032991150, sdgr-trials-group@schrodinger.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Day 1 to 28 days after the last dose of SGR-3515.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.