Phase
Condition
Neoplasms
Treatment
Raludotatug deruxtecan
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Participants must meet all of the following criteria to be eligible for enrollment into the trial:
Adults ≥18 years of age on the day of signing the ICF.
Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pre-treatment biopsy from a primary and/or metastatic lesion.
Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment.
Participants must have progressed radiologically on or after their most recent line of systemic therapy.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Additional inclusion criteria for endometrial cancer cohort
Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair status.
Documented disease progression after having received ≥1 line of therapy (no more than 3), including PBC-containing systemic treatment and an anti-PD-1 therapy containing regimen (combined or sequential) in the advanced/metastatic setting.
Additional inclusion criteria for cervical cancer cohort
Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.
Disease progression after having received ≥1 prior line of therapy that includes systemic therapy in the advanced or metastatic setting.
Additional inclusion criterion for non-HGSOC cohort
a. Pathologically or cytologically documented unresectable or metastatic CCOC, low grade endometrioid, low-grade serous, or mucinous OVC that was previously treated with at least 1 prior line of therapy.
Additional inclusion criteria for urothelial cancer cohort
Pathologically or cytologically documented unresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant.
Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting.
Additional inclusion criterion for the ccRCC cohort a. Pathologically or cytologically documented unresectable or metastatic ccRCC that was previously treated with no more than 3 prior systemic regimens for locally advanced or metastatic RCC, including both a PD-(L)1 checkpoint inhibitor and a VEGF-TKI in sequence or in combination.
Participants who meet any of the following criteria will be disqualified from entering the trial:
Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
Uncontrolled or significant cardiovascular disease as specified in the protocol.
Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Clinically severe pulmonary compromise
Chronic steroid treatment (>10 mg/day) with exceptions as noted in the protocol.
History of other active malignancy within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate >90%) and treated with expected curative outcome.
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline.
Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan, datopotamab deruxtecan).
Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
Has active or uncontrolled HIV, HBV, or HCV infection.
Study Design
Study Description
Connect with a study center
Hyogo Cancer Center
Akashi, 13-70
JapanActive - Recruiting
National Cancer Center Hospital
Chuo-ku, 104-0045
JapanActive - Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
JapanActive - Recruiting
Saitama Medical University International Medical Center
Hidaka, 1397-1
JapanActive - Recruiting
The Cancer Institute Hospital of Jfcr
Koto-ku,
JapanSite Not Available
Women's Cancer Care Associates
Albany, New York 12208
United StatesActive - Recruiting
Clinical Research Alliance
Westbury, New York 11590
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.