← Back to Search

Antibody-drug Conjugate

Ifinatamab Deruxtecan for Cancer

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 57 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 57 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 57 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 57 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Reporting Dose-limiting Toxicities in the HCC Cohort

Number of Participants Reporting Treatment-emergent Adverse Events and Death in the HCC Cohort

Objective Response Rate (ORR) as Assessed by Investigator

Secondary study objectives

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)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

13Treatment groups

Experimental Treatment

Group I: Cohort 9: Cervical cancerExperimental Treatment1 Intervention

Participants with recurrent or metastatic cervical cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.

Group II: Cohort 8: Ovarian cancerExperimental Treatment1 Intervention

Participants with recurrent or metastatic non-squamous ovarian 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 7: 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 IV: 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 V: 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 at the determined dose.

Group VI: 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 VII: 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 VIII: 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 IX: 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.

Group X: Cohort 13: Cutaneous melanomaExperimental Treatment1 Intervention

Participants with recurrent or metastatic cutaneous melanoma who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.

Group XI: Cohort 12: HER2 immunohistochemistry (IHC) 0 breast cancerExperimental Treatment1 Intervention

Participants with recurrent or metastatic HER2 immunohistochemistry (IHC) 0 breast cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.

Group XII: Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancerExperimental Treatment1 Intervention

Participants with recurrent or metastatic human epidermal growth factor 2 (HER2)-low breast cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.

Group XIII: Cohort 10: Biliary tract cancerExperimental Treatment1 Intervention

Participants with recurrent or metastatic biliary tract cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.

Do I qualify?Apply below to find out