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Monoclonal Antibodies
I-DXd for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Daiichi Sankyo Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 through disease progression within 8 cycles (each cycle is 21 days)
Awards & highlights
Study Summary
This trial is for people with advanced solid tumors who haven't been helped by other treatments. It's the first time this drug will be used in humans, and it will happen in two parts. The first part is to figure out how safe and tolerable the drug is, and the second part is to see how well it works against the tumor. The trial will last about 5 years.
Who is the study for?
This trial is for adults with advanced solid tumors that haven't responded to other treatments. Participants must be relatively active (ECOG score of 0 or 1), have at least one measurable tumor, and proper organ function. Specific cancers like head and neck, lung, bladder, sarcoma, endometrial cancer are included if standard treatments failed or aren't available.Check my eligibility
What is being tested?
The study tests a new drug called Ifinatamab deruxtecan (I-DXd) in two parts: first to find the safest high dose (Dose Escalation) and then to see how well it works at that dose (Dose Expansion). There's no set number of treatment cycles; patients benefitting may continue unless side effects become too severe.See study design
What are the potential side effects?
Since this is the first time I-DXd is used in humans, specific side effects are unknown but may include typical reactions to cancer drugs such as nausea, fatigue, allergic reactions, blood disorders or issues affecting organs where the drug acts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and cannot be surgically removed or has spread, and standard treatments haven't worked or aren't suitable.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 day 1 through disease progression within 8 cycles (each cycle is 21 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 through disease progression within 8 cycles (each cycle is 21 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the incidence of adverse events (AEs)
Evaluate the incidence of dose-limiting toxicities (DLTs)
Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)
Secondary outcome measures
Assess the incidence of anti-drug antibodies (ADAs)
Characterize the PK parameter AUClast
Characterize the PK parameter AUCtau
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose expansionExperimental Treatment1 Intervention
All participants enrolled in the dose expansion part
Group II: Dose escalationExperimental Treatment1 Intervention
All participants enrolled in the dose escalation part
Find a Location
Who is running the clinical trial?
Daiichi Sankyo Co., Ltd.Lead Sponsor
115 Previous Clinical Trials
48,836 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
162 Previous Clinical Trials
78,888 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a specific type of cancer drug related to trastuzumab deruxtecan.I have severe lung problems or need extra oxygen.I am currently fighting an infection that needs treatment.I have been treated with a B7-H3 targeted agent before.I have serious heart problems that are not under control.I have had other cancers in the last 3 years, but they were either skin cancer removed by surgery, early-stage cancers treated with a cure, superficial GI tract tumors, or non-muscle invasive bladder cancer treated endoscopically.My prostate cancer is resistant to hormone therapy and has spread to bones only.My cancer is advanced and cannot be surgically removed or has spread, and standard treatments haven't worked or aren't suitable.My heart, blood, kidney, and liver functions are all within normal ranges.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation
- Group 2: 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.
In what locations can this experiment be accessed?
"Currently, Sarah Cannon Research Institute at HealthONE in Denver, Colorado and John Theurer Cancer Center at Hackensack University Medical Center in Hackensack, New jersey as well as Washington University in Sarasota, Missouri are allowing patient enrollment for this clinical trial. Additionally there are 12 other sites across the nation accepting applicants."
Answered by AI
Are there any open recruitment slots for this clinical research?
"Confirmed: According to the information on clinicaltrials.gov, this clinical trial is seeking enrolment from 195 individuals between 12 different sites. The study was initially posted on November 3rd 2019 and last updated October 24th 2022."
Answered by AI
How extensive is the current cohort of trial participants?
"Affirmative. Records on clinicaltrials.gov show that this research endeavour, which was initially posted 11/3/2019 and recently updated 10/24/2022, is actively enrolling volunteers . Approximately 195 participants are needed to be recruited from a dozen distinct locations."
Answered by AI
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