SGR-3515 for Advanced Cancer
Recruiting at 9 trial locations
SP
Overseen ByStudy Physician
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Schrödinger, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
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.
How is the drug SGR-3515 different from other cancer treatments?
Research Team
MD
Margaret Dugan, MD
Principal Investigator
CMO/Study Physician
Eligibility Criteria
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
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.
Measurable disease per RECIST version 1.1
See 3 more
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.
See 3 more
Timeline
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
Treatment Details
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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment1 Intervention
28-day treatment cycle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Schrödinger, Inc.
Lead Sponsor
Trials
3
Recruited
150+
Findings from Research
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 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 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]
References
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. [2023]
Prospective phase II trial of everolimus in PIK3CA amplification/mutation and/or PTEN loss patients with advanced solid tumors refractory to standard therapy. [2022]
A phase 2 study of temsirolimus (CCI-779) in patients with soft tissue sarcomas: a study of the Mayo phase 2 consortium (P2C). [2022]
Phase II Clinical Trial of Everolimus in a Pan-Cancer Cohort of Patients with mTOR Pathway Alterations. [2022]
Therapeutic targets: MTOR and related pathways. [2021]
Other People Viewed
By Subject
By Trial
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.