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Antibody-drug Conjugate

R-DXd for Ovarian Cancer

Phase 2 & 3

Recruiting

Research Sponsored by Daiichi Sankyo, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status of 0 or 1

Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer

Must not have

Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC

Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to data cut off, up to 40 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if the R-DXd therapy is safe and effective for people with ovarian, peritoneal, or fallopian tube cancer.

Who is the study for?

This trial is for adults with high-grade ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based treatments. Participants must have a tumor suitable for biopsy and agree to provide tissue samples. They should have had prior therapy including bevacizumab unless unsuitable due to intolerance.

What is being tested?

The study tests R-DXd's safety and effectiveness against other drugs like Gemcitabine, Paclitaxel, Topotecan, PLD in patients with certain types of cancer. It aims to see if R-DXd can help where standard treatments haven't worked well.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, low blood cell counts increasing infection risk or bleeding tendency; organ-specific toxicity might also occur but varies by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or able to carry out light work.

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I have a specific type of ovarian, peritoneal, or fallopian tube cancer.

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I have had 1 to 3 treatments for cancer.

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I have a tumor that can be measured by CT or MRI scans.

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My condition does not improve with platinum-based treatments.

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I am eligible for and have not received the specific chemotherapy for ovarian cancer listed by the investigator.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My ovarian cancer is of a specific type (clear cell, mucinous, sarcomatous, mixed, or low-grade).

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I do not have active brain tumors, spinal cord compression, or cancer in the lining of my brain and spinal cord.

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I have not had a stroke, mini-stroke, or blood clot in my arteries in the last 6 months.

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I do not have serious heart problems.

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I have a history of lung inflammation not caused by infection.

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I have not had any cancer other than ovarian, peritoneal, or fallopian tube cancer in the last 3 years.

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I have been treated with drugs targeting CDH6 or using exatecan.

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My HIV infection is not well controlled.

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I have an active hepatitis B or C infection that is not under control.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have severe lung problems due to other lung diseases.

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I am not allergic to any components of the R-DXd treatment.

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I am on long-term steroid medication.

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I still have side effects from past cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to data cut off, up to 40 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to data cut off, up to 40 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to data cut off, up to 40 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

Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)

Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part B)

Progression-free Survival (PFS) Based on BICR Assessment (Part B)

Secondary study objectives

Cadherin-6 (CDH6) protein expression in tumor tissue as determined by immunochemistry assay and correlation with ORR, DoR, PFS and OS

Disease Control Rate (DCR)

Duration of Response (DOR)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Part B: R-DXd RP3D Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W).

Group II: Part A: R-DXd 6.4 mg/kg Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

Group III: Part A: R-DXd 5.6 mg/kg Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W).

Group IV: Part A: R-DXd 4.8mg/kg Q3WExperimental Treatment1 Intervention

Participants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W).

Group V: Part B: Investigator's ChoiceActive Control4 Interventions

Participants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), gemcitabine, or topotecan.

0 / 20Eligibility criteria met

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Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

422,022 Total Patients Enrolled

Daiichi SankyoLead Sponsor

411 Previous Clinical Trials

450,283 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,991 Previous Clinical Trials

5,179,930 Total Patients Enrolled

~433 spots leftby Dec 2027

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