Informations générales (source: ClinicalTrials.gov)
REJOICE-PanTumor01: A Phase 2, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants With Advanced/Metastatic Solid Tumors
Interventional
Phase 2
Daiichi Sankyo (Voir sur ClinicalTrials)
janvier 2025
septembre 2027
12 août 2025
This pan-tumor trial is designed as a signal-seeking trial to assess efficacy and safety
of raludotatug deruxtecan (R-DXd) monotherapy in locally advanced or metastatic solid
tumors with various cadherin-6 (CDH6) expression levels, including gynecological cancers
(endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer) and
genitourinary cancers (urothelial cancer and clear cell renal cell carcinoma [ccRCC]).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| François Baclesse Center - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Grp Hsp Diac Croix Saint Simon - 75012 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - 31100 - Toulouse cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Participants must meet all of the following criteria to be eligible for enrollment into
the trial:
1. Adults ≥18 years of age on the day of signing the ICF.
2. 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.
3. Has at least 1 measurable lesion according to RECIST version 1.1 per investigator
assessment.
4. Participants must have progressed radiologically on or after their most recent line
of systemic therapy.
5. Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Additional inclusion criteria for endometrial cancer cohort
1. Pathologically or cytologically documented endometrial cancer (carcinoma of any
histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair
status.
2. 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.
7. Additional inclusion criteria for cervical cancer cohort
1. Pathologically or cytologically documented recurrent or persistent squamous,
adenosquamous, or adenocarcinoma of the uterine cervix.
2. Disease progression after having received ≥1 prior line of therapy that
includes systemic therapy in the advanced or metastatic setting.
8. 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.
9. Additional inclusion criteria for urothelial cancer cohort
1. 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.
2. 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.
10. 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:
1. Clinically active brain metastases, spinal cord compression, or leptomeningeal
carcinomatosis
2. Any of the following within the past 6 months prior to enrollment: cerebrovascular
accident, transient ischemic attack, or other arterial thromboembolic event.
3. Uncontrolled or significant cardiovascular disease as specified in the protocol.
4. 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.
5. Clinically severe pulmonary compromise
6. Chronic steroid treatment (>10 mg/day) with exceptions as noted in the protocol.
7. 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.
8. 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.
9. 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).
10. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
11. Has active or uncontrolled HIV, HBV, or HCV infection.
the trial:
1. Adults ≥18 years of age on the day of signing the ICF.
2. 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.
3. Has at least 1 measurable lesion according to RECIST version 1.1 per investigator
assessment.
4. Participants must have progressed radiologically on or after their most recent line
of systemic therapy.
5. Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Additional inclusion criteria for endometrial cancer cohort
1. Pathologically or cytologically documented endometrial cancer (carcinoma of any
histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair
status.
2. 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.
7. Additional inclusion criteria for cervical cancer cohort
1. Pathologically or cytologically documented recurrent or persistent squamous,
adenosquamous, or adenocarcinoma of the uterine cervix.
2. Disease progression after having received ≥1 prior line of therapy that
includes systemic therapy in the advanced or metastatic setting.
8. 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.
9. Additional inclusion criteria for urothelial cancer cohort
1. 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.
2. 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.
10. 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:
1. Clinically active brain metastases, spinal cord compression, or leptomeningeal
carcinomatosis
2. Any of the following within the past 6 months prior to enrollment: cerebrovascular
accident, transient ischemic attack, or other arterial thromboembolic event.
3. Uncontrolled or significant cardiovascular disease as specified in the protocol.
4. 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.
5. Clinically severe pulmonary compromise
6. Chronic steroid treatment (>10 mg/day) with exceptions as noted in the protocol.
7. 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.
8. 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.
9. 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).
10. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
11. Has active or uncontrolled HIV, HBV, or HCV infection.