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S-531011 + Pembrolizumab for Cancer (aCCeleR8-001 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Shionogi Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
(Part A only) Participants should have 1 of the following tumor types: malignant melanoma (MEL), head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), urothelial carcinoma (UC), non-small cell lung cancer (NSCLC), or triple-negative breast cancer (TNBC), esophageal cancer (EC; esophageal squamous cell carcinoma and adenocarcinoma), or gastric cancer (GC; gastric and gastroesophageal junction adenocarcinoma).
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until the end of treatment (approximately 12 months).
Awards & highlights
aCCeleR8-001 Trial Summary
This trialtests a drug to see if it is safe and effective against cancer.
Who is the study for?
Adults with advanced or metastatic solid tumors without standard treatment options, or those who cannot tolerate such treatments. Participants must have measurable disease, a life expectancy of at least 12 weeks, and good performance status (able to carry out daily activities). They should not have autoimmune diseases requiring steroids, HIV infection, recent major surgery, uncontrolled brain metastases or other cancers within the last 3 years.Check my eligibility
What is being tested?
The trial is testing S-531011 alone and combined with Pembrolizumab in patients with various types of solid tumors. It aims to find the safest dose that can be given (MTD) and see how well it works against cancer (antitumor activity). The study has multiple parts: determining safe doses and then assessing effectiveness at these doses.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in different organs, infusion-related reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body's energy levels, digestive issues like nausea or diarrhea due to gastrointestinal tract involvement.
aCCeleR8-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have one of the specified types of cancer (e.g., melanoma, lung, breast).
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older and can legally consent.
aCCeleR8-001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until the end of treatment (approximately 12 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until the end of treatment (approximately 12 months).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Parts B and C: Disease Control Rate
Parts B and C: Duration of Response
+4 moreSecondary outcome measures
All Parts: Anti-S-531011 Antibody (ADA) Titer Level
All Parts: Changes in serum tumor markers from pretreatment to on-treatment
All Parts: Serum concentrations of S-531011
+15 moreaCCeleR8-001 Trial Design
4Treatment groups
Experimental Treatment
Group I: Part C: S-531011 + pembrolizumabExperimental Treatment2 Interventions
Participants will receive S-531011 at the RP2D in combination with pembrolizumab by intravenous infusion for up to approximately 12 months.
Group II: Part B: S-531011 MonotherapyExperimental Treatment1 Intervention
Participants will receive S-531011 at the the RP2D by intravenous infusion for up to approximately 12 months.
Group III: Part A-2: S-531011 + pembrolizumabExperimental Treatment2 Interventions
Participants will receive escalating doses of S-531011 in combination with pembrolizumab by intravenous infusion for up to approximately 12 months.
Group IV: Part A-1: S-531011 MonotherapyExperimental Treatment1 Intervention
Participants will receive escalating doses of S-531011 by intravenous infusion for up to approximately 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,898 Previous Clinical Trials
5,062,344 Total Patients Enrolled
Shionogi Inc.Lead Sponsor
8 Previous Clinical Trials
456 Total Patients Enrolled
ShionogiLead Sponsor
116 Previous Clinical Trials
41,212 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, or trying to become pregnant.My cancer type is one of those specifically selected for this trial's Part C.I have one of the specified types of cancer (e.g., melanoma, lung, breast).I have brain metastasis that is not under control.I am fully active or restricted in physically strenuous activity but can do light work.I stopped a specific cancer treatment due to severe side effects.My advanced cancer has no standard treatment options left, or I can't or won't use them.I am willing to provide fresh tumor samples before and during treatment.I have had a transplant of tissue or an organ from another person.I have not had major surgery in the last 28 days.I haven't received blood growth factors or transfusions in the last 14 days.I haven't had extensive radiotherapy in the last 28 days or any for palliation in the last 14 days, nor have I had radiation pneumonitis.I am 18 years old or older and can legally consent.I agree to let the study use my stored cancer tissue samples.I have recovered from past treatment side effects, except for hair loss and nerve issues.I have or had lung disease or inflammation treated with steroids.I haven't taken any cancer drugs in the last 28 days or 5 half-lives, whichever is shorter.I have another cancer that is getting worse or was treated in the last 3 years.My cancer type is one of those selected by the study after its first phase.My cancer type is one of those selected by the study after initial dose findings.My cancer type is one of those selected by the study after its first phase.I haven't had a serious infection or been hospitalized for one in the last 4 weeks.I do not have severe heart disease.My blood and organ tests show normal function.I have not received a live vaccine in the last 30 days.I have an autoimmune disease requiring daily steroids or immunosuppressants.I have never been treated with anti-CCR8 antibody.I am willing to provide tumor samples before and during treatment.I am at least 18 years old, or 20 if I am in Japan.
Research Study Groups:
This trial has the following groups:- Group 1: Part C: S-531011 + pembrolizumab
- Group 2: Part A-2: S-531011 + pembrolizumab
- Group 3: Part A-1: S-531011 Monotherapy
- Group 4: Part B: S-531011 Monotherapy
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.
Are there any unfilled slots for enrolment in this clinical trial?
"Affirmative. According to clinicaltrials.gov, the trial was first initiated on May 30th 2022 and has since been updated as recently as October 6th of this year. The study is currently recruiting a total of 274 patients from 3 different sites."
Answered by AI
To what medical condition is Part A-1: S-531011 Monotherapy most often applied?
"Part A-1: S-531011 Monotherapy is recommended for individuals dealing with malignant neoplasms, unresectable melanoma, or microsatellite instability high."
Answered by AI
Could you provide a chronology of prior experiments conducted concerning Part A-1: S-531011 Monotherapy?
"Part A-1: S-531011 Monotherapy was first administered in 2010 at City of Hope. Out of the 251 trials that have taken place, 961 are still recruiting participants with a significant proportion located in Los Angeles, California."
Answered by AI
How many humans are taking part in this medical test?
"This research project necessitates the recruitment of 274 suitable participants. Potential volunteers can sign up at either Angeles Clinic and Research Center in Los Angeles, or Henry Ford Health Centre in Michigan."
Answered by AI
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