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Monoclonal Antibodies
Combination Immunotherapy +/− Chemotherapy for Solid Cancers
Phase 1
Waitlist Available
Led By Nehal Lakhani, MD
Research Sponsored by Symphogen A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Sub-study 1 and 2: Patients with locally advanced or metastatic biliary tract carcinoma including adenocarcinoma of the intra- and/or extra-hepatic bile ducts and gallbladder carcinoma. Patients with ampullary cancers are excluded.
For all Sub-studies: Patients with an ECOG PS of 0 or 1, and anticipated life expectancy of ≥3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first study dose and throughout the trial, up to 2 years
Awards & highlights
Study Summary
This trial will study the effectiveness of different combinations of drugs for treating biliary tract carcinomas and esophageal squamous cell carcinomas. The safety and side effects of the combinations will also be evaluated.
Who is the study for?
This trial is for adults with advanced biliary tract carcinomas or esophageal squamous cell carcinoma who've had certain prior treatments. They must have measurable disease, good organ function, and use contraception. Exclusions include HIV/hepatitis infection, significant allergies to study drugs, recent severe health issues like bleeding disorders or autoimmune diseases.Check my eligibility
What is being tested?
The trial tests combinations of new cancer drugs: Sym021 with Sym022 or Sym023, and another group gets all three plus irinotecan. It aims to see how well these combos work on specific cancers by measuring tumor responses and monitoring safety.See study design
What are the potential side effects?
While the exact side effects aren't listed here, similar cancer drug trials often involve risks like immune reactions, infusion-related discomforts, fatigue, gastrointestinal issues (like nausea), liver enzyme changes, potential blood clots or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced or metastatic biliary tract cancer, but not ampullary cancer.
Select...
I can care for myself and am expected to live for at least 3 more months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first study dose and throughout the trial, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first study dose and throughout the trial, up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the AEs leading to dose interruption, dose delays, and permanent treatment stop of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym021+Sym023 +irinotecan)
To evaluate the incidence, severity, and relationship of (S)AEs collected from administration of the first dose of study drug until 30 days after the last dose of the 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irrinotecan)
To evaluate the preliminary efficacy of the combinations Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan in patients with BTC or ESCC by assessing overall response rates (ORRs) per Investigator assessment using RECISTv.1.1
Secondary outcome measures
Area under the serum concentration versus time curve (AUC) of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym021+Sym023+ irinotecan)
Evaluation Overall Survival (OS)
Evaluation of Disease Control Rate (DCR), defined as CR, PR, or stable disease (SD) ≥6 months
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Sym021+Sym023+irrinotecan for ESCC patientsExperimental Treatment3 Interventions
Sym021 will be infused over approximately 30 minutes (+10 minutes), followed by a 30-minute post-dosing interval before infusion of Sym023 over approximately 30 minutes (+10 minutes). The duration of each infusion may be extended by 30 minutes, or longer, if indicated. After another 30-minute post-dosing interval, irinotecan will be infused over 90 minutes.
Group II: Sym021+Sym023+irrinotecan for BTC patientsExperimental Treatment3 Interventions
Sym021 will be infused over approximately 30 minutes (+10 minutes), followed by a 30-minute post-dosing interval before infusion of Sym023 over approximately 30 minutes (+10 minutes). The duration of each infusion may be extended by 30 minutes, or longer, if indicated. After another 30-minute post-dosing interval, irinotecan will be infused over 90 minutes.
Group III: Sym021+Sym023 [ARM B] for BTC patientsExperimental Treatment2 Interventions
Sym021 will be infused over approximately 30 minutes (+10 minutes), followed by a 30-minute post-dosing interval before infusion of Sym023 over approximately 30 minutes (+10 minutes). The duration of each infusion may be extended by 30 minutes, or longer, if indicated.
Group IV: Sym021+Sym022 [ARM A] for BTC patientsExperimental Treatment2 Interventions
Sym021 will be infused over approximately 30 minutes (+10 minutes), followed by a 30-minute post-dosing interval before infusion of Sym022 over approximately 30 minutes (+10 minutes). The duration of each infusion may be extended by 30 minutes, or longer, if indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sym022
2017
Completed Phase 1
~110
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Sym021
2017
Completed Phase 1
~90
Sym023
2017
Completed Phase 1
~120
Find a Location
Who is running the clinical trial?
Symphogen A/SLead Sponsor
16 Previous Clinical Trials
824 Total Patients Enrolled
Nehal Lakhani, MDPrincipal InvestigatorSTART Midwest
1 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have advanced or metastatic biliary tract cancer, but not ampullary cancer.You have a current or possible autoimmune disease that is causing health problems.I have a serious eye condition.I have Gilbert's syndrome or the UGT1A1 7/7 genotype.I had severe side effects from immune therapy that stopped me from continuing it.I do not have any ongoing, uncontrolled bleeding issues.I have not been treated with specific immune therapies for my cancer.I have not had a blood clot or pulmonary embolism in the last 4 weeks.I have no ongoing major side effects from previous cancer treatments.You have allergies or sensitivities to any of the ingredients in the study drug.I do not have any serious or uncontrolled infections.I have advanced or metastatic esophageal squamous cell carcinoma.I have had an organ transplant.I am not on any treatments that include anti-TIM-3 or other immune therapies, except for anti-PD-(L)1 agents.My cancer has FGFR2 fusion/rearrangement or IDH1 mutation.My organ functions are within normal ranges according to recent tests.I am not taking warfarin for a past immune-related blood platelet issue, nor am I on strong medication that affects liver enzymes.I've only had gemcitabine and platinum-based chemo for my advanced cancer and haven't had anti-PD-(L)1 therapy.I've had first-line platinum chemotherapy and PD-(L)1 therapy for advanced cancer but it didn't work or I couldn't tolerate it.I have been treated with irinotecan before.I have a serious lung condition.I have had a serious gut problem in the last 6 months.I can care for myself and am expected to live for at least 3 more months.I have a brain tumor or cancer spread to the brain that is not yet treated or under control.I have a serious heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Sym021+Sym022 [ARM A] for BTC patients
- Group 2: Sym021+Sym023 [ARM B] for BTC patients
- Group 3: Sym021+Sym023+irrinotecan for BTC patients
- Group 4: Sym021+Sym023+irrinotecan for ESCC patients
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 are the prime goals of this medical experiment?
"This clinical trial is set to run until the point of disease progression or completion, whichever comes first. The primary aim is to evaluate adverse events associated with three different combinations of drugs (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irrinotecan). Secondary objectives involve assessing overall survival rates, peak plasma concentrations for irinotecan in the combination group and Cmax values for each mAb administered across all three drug combinations."
Answered by AI
Has Sym021 received the Federal Drug Administration's validation?
"Sym021's safety profile has been evaluated and rated a 1, as this is an early-stage trial with limited information on the drug's efficacy or toxicity."
Answered by AI
How many subjects are in the scope of this research project?
"Sadly, no new candidates are being accepted at this juncture. The trial was originally launched on October 12th 2020 and later modified on September 8th 2022. Nonetheless, there is still hope for those searching for similar clinical trials as 5403 studies with carcinoma and 263 Sym021 trials remain open to participants."
Answered by AI
Is enrollment for this trial open to new participants?
"According to the clinicaltrials.gov database, this trial is no longer recruiting patients. Although initial postings were made on October 12th 2020 and the last update was on September 8th 2021, there are over 5666 other trials that still require participants at present."
Answered by AI
Could you provide a record of the prior experiments conducted with Sym021?
"The first trial of Sym021 was conducted at Mayo Clinic in Rochester back in 2002. During the subsequent 18 years, 515 studies have been completed while 263 research efforts are actively recruiting participants - many of them located in Grand Rapids, Michigan."
Answered by AI
In what types of diseases does Sym021 demonstrate efficacy?
"Sym021 is primarily employed to target pancreatic cancer, however it may also be utilized for neoplasm metastasis, gastric tumors, and rhabdomyosarcomas."
Answered by AI
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