Ifinatamab Deruxtecan for Esophageal Cancer

Recruiting at 54 trial locations

Overseen By Daiichi Sankyo Contact for Clinical Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Daiichi Sankyo

Must not be taking: B7-H3 agents, Topoisomerase inhibitors

Disqualifiers: Adenosquamous carcinoma, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: Up to 54 months

510 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ifinatamab deruxtecan, a type of targeted therapy, for individuals with esophageal squamous cell carcinoma. The goal is to determine if this treatment outperforms standard chemotherapy for patients whose cancer has progressed after previous treatments. Participants will receive either the new drug or a standard chemotherapy selected by a doctor. The trial seeks individuals with advanced esophageal squamous cell cancer who have previously undergone treatments like platinum-based chemotherapy and immune therapy but require new options. As a Phase 3 trial, this study represents the final step before FDA approval, providing patients an opportunity to access a potentially more effective treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic steroid treatment, you may need to adjust your dosage if it is 10 mg daily or more of prednisone equivalent.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Ifinatamab Deruxtecan (I-DXd) has a manageable safety profile, meaning side effects are generally not severe and can be managed. In earlier trials with patients who had already received many treatments, I-DXd demonstrated promising results in fighting cancer. Patients experienced some side effects, but these were mostly manageable and did not cause serious health concerns.

Researchers are testing Ifinatamab Deruxtecan in patients with advanced esophageal squamous cell carcinoma, a type of esophageal cancer that does not respond well to other treatments. This trial aims to evaluate the drug's effectiveness and safety for these patients. Although still under investigation, results so far suggest it might be a safe option for those who have already tried other treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for esophageal cancer?

Unlike the standard chemotherapy options for esophageal cancer, Ifinatamab Deruxtecan (I-DXd) is an antibody-drug conjugate (ADC) that specifically targets cancer cells. This treatment combines an antibody that seeks out cancer cells with a potent chemotherapy drug, delivering the drug directly to the cancer cells while sparing more healthy cells. Researchers are excited because this targeted approach could potentially reduce side effects and improve effectiveness compared to traditional chemotherapy like docetaxel, paclitaxel, and irinotecan. By focusing on delivering treatment directly to cancer cells, I-DXd represents a promising advancement in precision medicine for esophageal cancer.

What evidence suggests that ifinatamab deruxtecan might be an effective treatment for esophageal cancer?

Research has shown that ifinatamab deruxtecan (I-DXd), which participants in this trial may receive, holds promise for patients with advanced esophageal squamous cell carcinoma (ESCC). Studies have found that it can shrink or slow tumor growth. It has been effective for patients who have already tried other treatments, such as chemotherapy and immune therapy, but still need more options. Patients using I-DXd have generally experienced manageable side effects. Overall, early evidence suggests that I-DXd could be a helpful treatment for those with hard-to-treat esophageal cancer. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for people with advanced or metastatic esophageal squamous cell carcinoma who've already tried platinum-based therapy and an immune checkpoint inhibitor. They should have measurable cancer that hasn't been treated by radiation, unless it's grown since then. Participants need to be fairly active (ECOG PS of 0 or 1) and have good organ function.

Inclusion Criteria

I have signed the informed consent form for this study.

I am fully active or restricted in physically strenuous activity but can do light work.

I can provide a tumor sample that meets the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either I-DXd or investigator's choice of chemotherapy in 21-day cycles

Up to 54 months

Every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ifinatamab Deruxtecan

Trial Overview The study compares the effectiveness and safety of a new drug called Ifinatamab Deruxtecan against standard chemotherapy options like Docetaxel, Paclitaxel, or Irinotecan HCl in patients whose cancer has progressed after initial treatments.

How Is the Trial Designed?

Group I: I-DXd Experimental Treatment 1 Intervention

Participants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).

Group II: Investigator's Choice of Chemotherapy (ICC) Active Control 3 Interventions

Participants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. daiichisankyo.us daiichisankyo.us/press-releases/-/article/ideate-esophageal01-phase-3-trial-of-ifinatamab-deruxtecan-initiated-in-certain-patients-with-pretreated-advanced-or-metastatic-esophageal-squamous-cell-carcinoma

IDeate-Esophageal01 Phase 3 Trial of Ifinatamab ... ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)02713-8/fulltext

690P Ifinatamab deruxtecan (I-DXd; DS-7300) in patients ... I-DXd continues to demonstrate a manageable safety profile and promising antitumor activity with encouraging DOR and OS in these heavily pretreated patients, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06644781

NCT06644781 | A Study of Ifinatamab Deruxtecan in ... This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal ...

4. targetedonc.com targetedonc.com/view/first-patient-dosed-in-study-of-i-dxd-in-esophageal-cancer

First Patient Dosed in Study of I-DXd in Esophageal Cancer “Patients with metastatic esophageal squamous cell carcinoma continue to experience poor outcomes despite currently available treatments,” said ...

5. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/merck-daiichi-sankyo-antibody-drug-conjugate-esophageal-squamous-cell-carcinoma

Merck and Daiichi Sankyo Launch Global Phase III Trial of ... I-DXd demonstrated promise treating patients with metastatic lung, prostate, and esophageal cancer in the first-in-human, open-label Phase I/II ...