SGR-3515 for Advanced Cancer

Recruiting at 13 trial locations

Overseen By Study Physician

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Schrödinger, Inc.

Must not be taking: Anti-cancer treatments

Disqualifiers: CNS tumors, Recent surgeries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug, SGR-3515, to determine its effects on advanced solid tumors (large masses of cancer cells). Researchers seek to understand if this drug can serve as a useful treatment option for these types of cancers. Suitable participants have advanced cancer that has spread and can be measured by doctors.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have received any systemic anti-cancer treatments or investigational agents within 21 days before starting the study drug.

Is there any evidence suggesting that SGR-3515 is likely to be safe for humans?

Research shows that SGR-3515 is a new treatment under exploration for advanced cancer. So far, researchers have tested SGR-3515 only in labs, not in people. These lab studies suggest that SGR-3515 can effectively fight tumors.

As a Phase 1 trial, this will be the first time SGR-3515 is tested in humans. The main goal is to assess its safety and determine the right dose. Specific safety information in humans is not yet available, but this phase focuses on understanding human reactions to the treatment and monitoring for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SGR-3515 for advanced cancer because it represents a new approach compared to traditional treatments like chemotherapy and radiation. SGR-3515 is unique because it targets cancer cells more precisely, potentially minimizing damage to healthy cells and reducing side effects. Additionally, it operates through a novel mechanism that may overcome resistance seen with current therapies, offering new hope for patients who have limited options.

What evidence suggests that SGR-3515 might be an effective treatment for advanced cancer?

Research has shown that SGR-3515, the investigational treatment in this trial, could help treat advanced solid tumors. Early studies suggest that SGR-3515 outperforms some current treatments against tumors. Specifically, it has shown better results than other drugs targeting proteins called Wee1 and Myt1, which are involved in cell growth. This suggests that SGR-3515 might effectively slow down or stop tumor growth. It is designed to work well while causing fewer side effects, such as blood problems, which are common with similar drugs. These findings offer hope that SGR-3515 could be a strong option for fighting advanced cancers. ^{3 4 6 7 8}

Who Is on the Research Team?

Margaret Dugan, MD

Principal Investigator

CMO/Study Physician

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Measurable disease per RECIST version 1.1

My cancer has spread to other parts of my body.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I haven't had a serious cancer other than this one in the last 2 years.

My cancer originated in the brain or spinal cord.

I haven't taken any cancer drugs or experimental treatments within the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SGR-3515 in a 28-day treatment cycle to evaluate safety, tolerability, and preliminary anti-tumor activity

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of adverse events

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SGR-3515

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 1 Intervention

28-day treatment cycle.

Who Is Running the Clinical Trial?

Schrödinger, Inc.

Lead Sponsor

Trials

3

Recruited

150+

Published Research Related to This Trial

In a phase II trial involving 30 patients with advanced solid tumors harboring TSC1/TSC2 or MTOR mutations, everolimus showed a low objective response rate of only 7%, indicating limited efficacy for this treatment in the selected patient population.

The most common side effect was mucositis, experienced by 27% of patients, highlighting the need for careful monitoring of adverse events during treatment, although one patient suffered a fatal pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II Clinical Trial of Everolimus in a Pan-Cancer Cohort of Patients with mTOR Pathway Alterations. Adib, E., Klonowska, K., Giannikou, K., et al.[2022]

mTOR inhibitors, such as rapamycin and its derivatives, are being studied as promising anticancer treatments due to their role in controlling malignant cell growth, with clinical trials showing they are well tolerated by patients.

These inhibitors may lead to prolonged stable disease and tumor regressions, particularly in patients whose cancer is linked to the activation of the PI3K pathway or abnormal expression of certain proteins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic targets: MTOR and related pathways. Dancey, JE.[2021]

In a phase II trial involving 10 patients with advanced solid tumors and specific genetic alterations, everolimus did not show significant anti-tumor activity, as no complete or partial responses were observed, and the study did not progress to the second stage.

Despite the lack of efficacy, everolimus was well-tolerated, with no severe toxicities reported, indicating a safety profile that warrants further exploration with different treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective phase II trial of everolimus in PIK3CA amplification/mutation and/or PTEN loss patients with advanced solid tumors refractory to standard therapy. Kim, ST., Lee, J., Park, SH., et al.[2022]

In a Phase 1b study involving 110 patients with advanced solid tumors, gedatolisib combined with cisplatin showed promising clinical activity in triple-negative breast cancer (TNBC), with an overall response rate of 40% in first-line treatment and 33.3% in second/third-line treatment.

The combination therapy was generally well-tolerated, with only 10% of evaluable patients experiencing dose-limiting toxicities, primarily grade 3 oral mucositis, indicating a manageable safety profile for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1B open-label study of gedatolisib (PF-05212384) in combination with other anti-tumour agents for patients with advanced solid tumours and triple-negative breast cancer. Curigliano, G., Shapiro, GI., Kristeleit, RS., et al.[2023]

In a trial involving 41 patients with advanced soft tissue sarcomas, temsirolimus showed limited efficacy, with only 5% of patients achieving a confirmed partial response, and a median overall survival of 7.6 months.

The treatment was associated with moderate toxicities, as 43% of patients experienced grade 3 or higher adverse events, indicating that while temsirolimus may have some activity, its safety profile raises concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2 study of temsirolimus (CCI-779) in patients with soft tissue sarcomas: a study of the Mayo phase 2 consortium (P2C). Okuno, S., Bailey, H., Mahoney, MR., et al.[2022]

Citations

1. schrodinger.com schrodinger.com/pipeline/wee1-myt1/

SGR-3515 Wee1/Myt1 - Schrödinger, Inc. The profile of SGR-3515 enables dosing schedules optimized to maintain anti-tumor activity and limit hematological toxicity. SGR-3515 is currently in clinical ...

2. trialx.com trialx.com/clinical-trials/listings/323057/study-of-sgr-3515-in-participants-with-advanced-solid-tumors/

Study of SGR-3515 In Participants With Advanced Solid ... SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting ...

3. biospace.com biospace.com/press-releases/schrodinger-presents-new-preclinical-data-at-aacr-annual-meeting

Schrödinger Presents New Preclinical Data at AACR ... The data demonstrated that SGR-3515 has improved anti-tumor activity in preclinical models compared to known Wee1 and Myt1 monotherapy inhibitors.

4. trial.medpath.com trial.medpath.com/news/7947e58e9d89a1a1/schrodinger-unveils-promising-preclinical-data-for-novel-cancer-therapeutics-at-aacr-2025

Schrödinger Unveils Promising Preclinical Data for Novel ... Preclinical data presented for SGR-3515View drug details demonstrated superior anti-tumor activity compared to existing Wee1 inhibitor ZN-c3View drug details ...

5. withpower.com withpower.com/trial/sgr-3515-for-advanced-cancer-11cdc

SGR-3515 for Advanced Cancer 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. Show more.

6. ir.schrodinger.com ir.schrodinger.com/press-releases/news-details/2024/Schrdinger-Presents-SGR-3515-Preclinical-Data-at-2024-EORTC-NCI-AACR-Symposium/default.aspx

Schrödinger Presents SGR-3515 Preclinical Data at 2024 ... The data demonstrate that in preclinical models, treatment with SGR-3515 results in synergistic anti-tumor activity that leads to deeper and ...

7. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/3025/759041/Abstract-3025-Optimization-of-therapeutic-index-of

Abstract 3025: Optimization of therapeutic index of SGR-3515 ... SGR-3515 is a novel and potent small molecule inhibitor of Wee1/Myt1. The co-inhibition of Wee1 and Myt1 induces rapid DNA damage and causes significant tumor ...

8. clin.larvol.com clin.larvol.com/trial-detail/NCT06463340

Study of SGR-3515 In Participants With Advanced Solid ... The data demonstrate that in preclinical models, treatment with SGR-3515 results in synergistic anti-tumor activity that leads to deeper and more durable ...