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Antibody-drug Conjugate
Cohort 5: Hepatocellular Carcinoma for Solid Tumors
Phase 2
Recruiting
Research Sponsored by Daiichi Sankyo
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 baseline up to 52 months
Awards & highlights
Study Summary
This trial aims to investigate various types of tumors including endometrial cancer, head and neck cancer, pancreatic cancer, colorectal cancer, liver cancer, esophageal cancer, lung cancer, and bladder
Who is the study for?
This trial is for adults with certain types of advanced or metastatic solid tumors that have worsened after previous treatments. Participants need to have a measurable tumor, be able to provide tissue samples, and must not have serious health issues affecting their organs. Women who can bear children and men must agree to use effective contraception.Check my eligibility
What is being tested?
The study tests Ifinatamab Deruxtecan (I-DXD) on various solid tumors including cancers of the endometrium, head & neck, pancreas, colon & rectum, liver, esophagus/stomach junction & stomach itself, lung (non-squamous), and urinary system.See study design
What are the potential side effects?
Potential side effects of I-DXD may include reactions at the infusion site, fatigue, nausea or vomiting; however specific side effects will depend on individual patient factors and the type of tumor being treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 52 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 52 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) as Assessed by Investigator
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
+10 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 8: Urothelial carcinomaExperimental Treatment1 Intervention
Participants with recurrent or metastatic urothelial carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Group II: Cohort 7: Non-squamous non-small cell lung cancerExperimental Treatment1 Intervention
Participants with recurrent or metastatic non-squamous non-small cell lung cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Group III: Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomachExperimental Treatment1 Intervention
Participants with recurrent or metastatic adenocarcinoma of esophagus, gastroesophageal junction, and stomach who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Group IV: Cohort 5: Hepatocellular CarcinomaExperimental Treatment1 Intervention
Participants with recurrent or metastatic hepatocellular carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Group V: Cohort 4: Colorectal CancerExperimental Treatment1 Intervention
Participants with recurrent or metastatic colorectal cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Group VI: Cohort 3: Pancreatic Ductal AdenocarcinomaExperimental Treatment1 Intervention
Participants with recurrent or metastatic pancreatic ductal adenocarcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Group VII: Cohort 2: Head and Neck Squamous Cell CarcinomaExperimental Treatment1 Intervention
Participants with recurrent or metastatic head and neck squamous carcinoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Group VIII: Cohort 1: Endometrial CancerExperimental Treatment1 Intervention
Participants with recurrent or metastatic endometrial cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Find a Location
Who is running the clinical trial?
Daiichi SankyoLead Sponsor
393 Previous Clinical Trials
416,041 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,894 Previous Clinical Trials
5,061,052 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals still eligible to participate in this ongoing research?
"As per information on clinicaltrials.gov, this investigation is currently seeking eligible participants. The trial was first listed on April 10th, 2024, and the last modification was made on April 12th of the same year."
Answered by AI
What is the current number of individuals being admitted into this particular medical trial?
"Indeed, the details available on clinicaltrials.gov indicate that this research study is actively seeking participants. Initially shared on April 10, 2024, and last modified on April 12, 2024, the trial aims to enroll 260 individuals from a single site."
Answered by AI
Has Cohort 5 received approval from the FDA for treating Hepatocellular Carcinoma?
"The safety assessment for Cohort 5 focusing on Hepatocellular carcinoma has been rated a 2 by our experts at Power. This Phase 2 trial indicates some evidence supporting safety, yet no data backs its efficacy as of now."
Answered by AI
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