A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

NCT04707248 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: DS6000-A-U101
• Study Type: interventional
• Target: 179
• Locations: 2 countries
• Sites: 13

Brief Summary

This clinical trial will evaluate raludotatug deruxtecan (R-DXd; DS-6000a) in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main goals of this study will be to investigate the recommended dose of R-DXd that can be given safely to participants, assess the adverse events of R-DXd, and evaluate the effectiveness of R-DXd.

Conditions

Renal Cell Carcinoma; Ovarian Tumor

Keywords

Renal Cell Carcinoma; Ovarian Tumor; Raludotatug deruxtecan (R-DXd; DS-6000a)

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Dose-limiting toxicities (DLTs)

  Day 1 to Day 21 in Cycle 1 (each cycle is 21 days)

• Number of Participants Reporting Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest

  From start of treatment up to 40 days after last dose, up to approximately 52 months

• Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Dose Expansion)

  ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR).

  From start of treatment (Cycle 1, Day 1) up to disease progression, up to approximately 52 months (each cycle is 21 days)

Secondary Outcomes (12)

• Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve from Time Zero to 21 Days (AUC 21d) for R-DXd and its Metabolites

  Cycles 1 and 3, Day 1: Predose, 3 hours, 5 hours, 8 hours postdose, end of infusion (EOI); Cycles 1 and 3, Day 2; Cycles 1 and 3, Days 4, 8, and 15; Cycle 2, Day 1: predose and EOI; Cycle 4, Day 1 and every then 2 cycles: predose (each cycle is 21 days)

• Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve Up to the Last Quantifiable Time (AUClast) for R-DXd and its Metabolites

  Cycles 1 and 3, Day 1: Predose, 3 hours, 5 hours, 8 hours postdose, end of infusion (EOI); Cycles 1 and 3, Day 2; Cycles 1 and 3, Days 4, 8, and 15; Cycle 2, Day 1: predose and EOI; Cycle 4, Day 1 and every then 2 cycles: predose (each cycle is 21 days)

• Pharmacokinetic Analysis Maximum Plasma Concentration (Cmax) for R-DXd and its Metabolites

  Cycles 1 and 3, Day 1: Predose, 3 hours, 5 hours, 8 hours postdose, end of infusion (EOI); Cycles 1 and 3, Day 2; Cycles 1 and 3, Days 4, 8, and 15; Cycle 2, Day 1: predose and EOI; Cycle 4, Day 1 and then every 2 cycles: predose (each cycle is 21 days)

• Pharmacokinetic Analysis Lowest Plasma Concentration (Ctrough) for R-DXd and its Metabolites

  Cycles 1 and 3, Day 1: Predose, 3 hours, 5 hours, 8 hours postdose, end of infusion (EOI); Cycles 1 and 3, Day 2; Cycles 1 and 3, Days 4, 8, and 15; Cycle 2, Day 1: predose and EOI; Cycle 4, Day 1 and then every 2 cycles: predose (each cycle is 21 days)

• Pharmacokinetic Analysis Time to Maximum Plasma Concentration (Tmax) for R-DXd and its Metabolites

  Cycles 1 and 3, Day 1: Predose, 3 hours, 5 hours, 8 hours postdose, end of infusion (EOI); Cycles 1 and 3, Day 2; Cycles 1 and 3, Days 4, 8, and 15; Cycle 2, Day 1: predose and EOI; Cycle 4, Day 1 and then every 2 cycles: predose (each cycle is 21 days)

Study Arms (3)

Dose Escalation

EXPERIMENTAL

Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) will receive an intravenous infusion of R-DXd (starting dose 1.6 mg/kg).

Drug: DS-6000a

Dose Expansion: Cohort B-1

EXPERIMENTAL

Participants with RCC will receive an intravenous infusion of R-DXd at the RDE. Enrollment has ended for this cohort.

Drug: DS-6000a

Dose Expansion: Cohort B-2

EXPERIMENTAL

Participants with OVC will receive an intravenous infusion of R-DXd at the RDE.

Drug: DS-6000a

Interventions

DS-6000a DRUG

Intravenous administration at doses starting at 1.6 mg/kg on Day 1 of Cycle 1

Also known as: R-DXd

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• At least 18 years of age
• Eastern Cooperative Oncology Group Performance Status score of 0 or 1
• Availability of archived tumor tissue samples
• Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before start of study treatment
• Has adequate organ function within 7 days before the start of study treatment
• Has an adequate treatment washout period prior to start of study treatment
• Male participants with female partners of childbearing potential and female participants of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug.

You may not qualify if:

• Has had prior treatment with other CDH6-targeted agents
• Has had prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, datopotamab deruxtecan, ifinatamab deruxtecan, DS-3939)
• Has history or current presence of CNS metastases except for participants who have completed radiotherapy or surgery ≥2 weeks before the start of study treatment and have no evidence of disease progression in the CNS and no requirement for chronic corticosteroid therapy within 2 weeks before the start of study treatment
• Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years)
• Has a history of myocardial infarction or unstable angina within 6 months before start of study treatment
• Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia requiring treatment
• Lung-specific intercurrent clinically significant illnesses
• Has an uncontrolled infection requiring systemic therapy

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (13)

Arizona Oncology Associates, PC HOPE (A)A HOPE)

Tucson, Arizona, 85711, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Florida Cancer Lake Mary

Lake Mary, Florida, 32746, United States

Location

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Tokyo, 277-8577, Japan

Location

National Hospital Organization Kyusyu Cancer Center

Fukuoka, 811-1395, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Kōtoku, 135-0063, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, 791-0280, Japan

Location

Shizuoka Cancer Center

Nakatogari, 411-8777, Japan

Location

Saitama Medical University International Medical Center

Saitama, 350-1298, Japan

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 13, 2021
• Study Start: December 22, 2020
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (6); JP (7)