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Phase 2 Pan-Tumor Trial of R-DXd for Advanced/Metastatic Solid Tumors
EU CTIS ID: 2024-513307-13-00
What this study is testing
For all cohorts except ccRCC: To evaluate the efficacy of R-DXd treatment measured by ORR as assessed by the investigator For ccRCC cohort only: To evaluate the efficacy of R-DXd treatment measured by DCR as assessed by the investigator To assess safety and tolerability of R-DXd
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
- 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 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 (ECOG) performance status (PS) of 0 or 1.
You likely can't join if
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis.
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- Has active or uncontrolled HIV, HBV or HCV infection.
- 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.
See the full eligibility criteria
Who can join
- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
- 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 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 (ECOG) performance status (PS) of 0 or 1.
- Additional inclusion criteria for endometrial cancer cohort a. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair status. b. 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 a. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix. b. 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, lowgrade 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 a. 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. b. 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.
What rules you out
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis.
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- Has active or uncontrolled HIV, HBV or HCV infection.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- China
- Japan
- Korea, Republic of
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Japan; Korea, Republic of; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.