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PD-1/PD-L1 Inhibitor
SL-279252 for Cancer
Phase 1
Waitlist Available
Research Sponsored by Shattuck Labs, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 32 months
Awards & highlights
Study Summary
This trial is testing a new drug to treat cancer. It will evaluate how well the drug works and how safe it is.
Who is the study for?
Adults with certain advanced solid tumors or lymphomas who have tried, can't tolerate, or aren't eligible for standard treatments. They must be in relatively good health (ECOG PS of 0 or 1), not pregnant, willing to use contraception, and without a history of severe reactions to PD-1/L1 therapy. Exclusions include prior OX40 agonist treatment and specific medical conditions.Check my eligibility
What is being tested?
SL-279252 is being tested in this Phase 1 trial for safety, tolerability, how the body processes it (pharmacokinetics), its effectiveness against cancer (anti-tumor activity), and biological effects on the body (pharmacodynamics). Participants will receive escalating doses to find an optimal dose that's both safe and effective.See study design
What are the potential side effects?
As SL-279252 is new and being tested for the first time in humans, potential side effects are unknown but may include typical immune-related reactions such as inflammation in organs, infusion-related symptoms like fever or chills, fatigue, digestive issues like nausea or diarrhea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 32 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of SL-279252
Safety profile of SL-279252 - Incidence of all treatment emergent adverse events
Secondary outcome measures
Area under the serum concentration-time curve (AUC)
Clearance
Establish the recommended phase 2 dose of SL-279252
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SL-279252Experimental Treatment1 Intervention
Intravenous administration; Two possible dosing schedules for SL-279252 may be evaluated
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Who is running the clinical trial?
Shattuck Labs, Inc.Lead Sponsor
4 Previous Clinical Trials
301 Total Patients Enrolled
Shattuck LabsStudy DirectorShattuck Labs
4 Previous Clinical Trials
301 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a certain type of head and neck cancer that started in the mouth, throat or voice box. If your cancer started in other places like the nose or sinuses, you cannot participate.You are physically able to perform everyday activities and take care of yourself without assistance, or you have some symptoms but are still able to carry out daily activities with little assistance.You cannot have had to stop a previous PD-1/L1 therapy due to side effects affecting your immune system.You are currently breastfeeding.You have a mental health condition or life circumstances that may make it difficult for you to follow the study requirements or understand the risks involved.You have had a transplant surgery where someone else's cells or organs were used.You are expected to live for at least 12 more weeks.You have already received two or more treatments that contain checkpoint inhibitors or have been treated with an OX40 agonist before.You cannot receive chemotherapy, immunotherapy, biologic therapy, or hormonal therapy at the same time as the study treatment.You are currently taking corticosteroids or other medications that weaken your immune system, or have taken them within the last 14 days, except for certain cases.You have an autoimmune disease that is currently active or has been diagnosed in the past (with some exceptions).You have a heart condition that is not under control and could affect your health during the study.You are 18 years old or older.You have a type of cancer that cannot be treated with standard therapy or you have tried standard therapy but it didn't work or caused intolerable side effects.You have been diagnosed with one of several types of advanced or metastatic cancers, including melanoma, lung cancer, bladder cancer, head and neck cancer, cervical cancer, stomach cancer, anal cancer, kidney cancer, Hodgkin's lymphoma, or certain types of solid tumors.You are not eligible for the study if you have a certain type of genetic mutation (EGFR sensitizing or ALK fusion) in your non-small cell lung cancer.You can only be part of the study if you meet all of the following requirements.You have given your written permission to take part in the study, following the rules and regulations set by your local authorities.You have tumors that can be measured and tracked by specific medical guidelines called iRECIST or RECIL 2017.You have a type of cancer for which there is no approved standard treatment available, or you have tried standard treatment and it did not work for you, or you cannot receive standard treatment due to intolerances or other reasons.You have an ongoing stomach or intestinal problem that causes symptoms like pain, discomfort, or diarrhea.You have another cancer that needs to be treated and could make it difficult to track your response to the treatment being studied.
Research Study Groups:
This trial has the following groups:- Group 1: SL-279252
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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