Your session is about to expire
← Back to Search
Monoclonal Antibodies
SRF114 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Coherus Biosciences, 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 up to 24 months
Awards & highlights
Study Summary
This trial will test a new antibody drug to treat solid tumors. Patients are needed to join.
Who is the study for?
Adults with advanced solid tumors, including head and neck squamous cell carcinoma, who have measurable lesions and whose major organs are functioning well. They must not have had more than four prior systemic treatments for advanced disease, no recent major surgery, and cannot be on certain blood thinners if providing biopsies.Check my eligibility
What is being tested?
SRF114 is being tested in this study. It's a new monoclonal antibody targeting CCR8 given as monotherapy to see how safe it is and how well it works against different types of solid tumors in adults.See study design
What are the potential side effects?
Potential side effects may include allergic reactions similar to other monoclonal antibodies which can range from mild skin reactions to severe anaphylaxis, organ inflammation, fatigue, or changes in blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
[Arms 1a, 1b, and 2] Rate of Dose Limiting Toxicity (DLT)
Secondary outcome measures
Anti-drug Antibodies (ADAs) to CHS-114
[Arms 1a and 1b] Changes in FOXP3 levels in participants undergoing pretreatment and on-treatment tumor biopsies
[Arms 1a and 1b] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs).
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Arm 2: CHS-114 + toripalimab Dose ExpansionExperimental Treatment2 Interventions
Arm 2 combination dose expansion will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 dose recommended Phase 2 dose [RDE] levels in up to 6 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC).
Group II: Arm 1b: CHS-114 Dose ExpansionExperimental Treatment1 Intervention
Arm 1b monotherapy expansion will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CHS-114 monotherapy at 2 dose levels (potential recommended dose for expansion [RDE]) in up to 5 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC).
Group III: Arm 1a: CHS-114 Dose EscalationExperimental Treatment1 Intervention
Arm 1 monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CHS-114 as monotherapy in up to 25 participants with advanced solid tumors, to determine the recommended dose for expansion (RDE).
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Coherus Biosciences, Inc.Lead Sponsor
11 Previous Clinical Trials
3,229 Total Patients Enrolled
Surface OncologyLead Sponsor
5 Previous Clinical Trials
642 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have previously been treated with anti-CCR8 therapy.I have not had major surgery in the last 4 weeks.I have had a severe allergic reaction to monoclonal antibody therapy or its ingredients.My advanced cancer has worsened despite treatment, and no other treatments are suitable for me.I have had 4 or fewer treatments for my advanced cancer.I am on long-term blood thinners that can't be stopped for biopsies.I agree to use birth control during the study if I am not sterile or postmenopausal.My advanced head and neck cancer progressed after treatment with platinum-based chemo or PD-1/PD-L1 inhibitors.My tumor can be biopsied before and during treatment, and I agree to these procedures.My side effects from previous cancer treatments are mild or gone.My head or neck cancer cannot be cured with surgery or radiation.My cancer is in the nose or throat but not HNSCC.My treated cancer area has grown despite previous treatments.I am 18 years old or older.My blood counts for neutrophils, hemoglobin, and platelets are within the required ranges.It's been long enough since my last cancer treatment to start a new one.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: CHS-114 + toripalimab Dose Expansion
- Group 2: Arm 1a: CHS-114 Dose Escalation
- Group 3: Arm 1b: CHS-114 Dose Expansion
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment capacity for this trial?
"Yes, the data hosted on clinicaltrials.gov verifies that this experiment is presently actively enrolling participants. This investigation was first published on December 15th 2022 and has been recently updated on January 2nd 2023. 70 patients are being recruited from a single site for this trial."
Answered by AI
Is recruitment for this experiment still ongoing at the moment?
"Affirmative. As evidenced by the clinicaltrials.gov website, this trial is actively seeking patients and was initially published on December 15th 2022 and subsequently updated on January 2nd 2023. 70 participants are required to be enrolled at a single medical centre."
Answered by AI
What is the ultimate goal of this medical experiment?
"According to the trial's sponsor, Surface Oncology, their primary objective which will be evaluated during a 21 day period is Confirmed Objective Response Rate (ORR). Additionally, this study looks at secondary outcomes such as Summary of Adverse Events (AEs) based on Treatment Emergent AEs (TEAEs), Pharmacokinetics (PK) of SRF114 and Progression-Free Survival (PFS) defined by RECIST v1.1."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger