Investigational Drug
Raludotatug Deruxtecan
TrialFetch AI Analysis
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Overview
Raludotatug deruxtecan (R-DXd; DS-6000a) is an investigational antibody–drug conjugate being studied for ovarian and other cancers. Human results are available from early-phase studies, but its benefit relative to standard treatment has not yet been established; a phase 3 comparison in platinum-resistant ovarian cancer is underway. (pmc.ncbi.nlm.nih.gov)
Mechanism of action
R-DXd combines an antibody targeting cadherin-6 (CDH6) with DXd, a DNA topoisomerase I inhibitor, through a cleavable linker. The intended effect is to deliver the cancer-killing payload to CDH6-expressing tumor cells. (pmc.ncbi.nlm.nih.gov)
Efficacy
In the phase 2 dose-optimization portion of REJOICE-Ovarian01, 107 patients with previously treated, platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer received R-DXd. The independently assessed objective response rate was 50.5% overall: 44.4% at 4.8 mg/kg, 50.0% at 5.6 mg/kg, and 57.1% at 6.4 mg/kg. Three patients had complete responses. These are non-comparative results and do not establish whether R-DXd improves survival or outperforms existing treatment. (annalsofoncology.org)
Safety
In that phase 2 analysis, the most frequent treatment-emergent adverse events were nausea (69.2%), anemia (57.0%), and asthenia (46.7%). Grade 3 or higher events occurred in 52.3% of patients. Treatment-related interstitial lung disease was reported in four patients (3.7%), including one grade 3 case. Treatment-related adverse events led to dose reduction in 18.7% and discontinuation in 5.6%. (annalsofoncology.org)
Further reading
- Phase 2 REJOICE-Ovarian01 results, Annals of Oncology conference abstract
- Mechanism and preclinical research, Molecular Cancer Therapeutics
- Phase 3 study design, Journal of Clinical Oncology conference abstract
Last updated: Sep 2026
Active trials using Raludotatug Deruxtecan
Found 5 active trials using this drug:
TrialFetch AI summary: Adults with stage IV squamous NSCLC that has progressed after anti-PD-(L)1 therapy and platinum-based chemotherapy are randomized to raludotatug deruxtecan (a cadherin-6–targeted ADC), ifinatamab deruxtecan (a B7-H3–targeted ADC), or docetaxel. Both ADCs deliver a topoisomerase I inhibitor payload.
ClinicalTrials.gov ID: NCT06780098
TrialFetch AI summary: Adults with stage IV nonsquamous NSCLC progressing after anti-PD-(L)1 therapy and platinum chemotherapy are randomized to docetaxel or one of two antibody–drug conjugates: raludotatug deruxtecan (CDH6-targeted) or ifinatamab deruxtecan (B7-H3-targeted), both delivering a topoisomerase I inhibitor. Patients must have ECOG 0–1 and no indication for first-line EGFR-, ALK-, or ROS1-directed therapy.
ClinicalTrials.gov ID: NCT06780085
TrialFetch AI summary: This study enrolls patients with measurable relapsed high-grade serous ovarian, primary peritoneal, or fallopian tube cancer after 1–3 prior lines of therapy. Patients with platinum-sensitive disease receive raludotatug deruxtecan, an investigational CDH6-targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor, with carboplatin or paclitaxel; those with platinum-resistant disease receive it with bevacizumab.
ClinicalTrials.gov ID: NCT06843447
TrialFetch AI summary: Adults with measurable, platinum-resistant high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer, ECOG 0–1, and 1–3 prior treatment lines receive raludotatug deruxtecan, a CDH6-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor. The study first evaluates three doses, then compares the selected dose with investigator’s choice of paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan.
ClinicalTrials.gov ID: NCT06161025
TrialFetch AI summary: Adults with extensive-stage SCLC progressing after exactly one platinum-based regimen containing a PD-1/PD-L1 inhibitor receive second-line investigational treatment; eligibility requires ECOG 0–1 and measurable disease. Regimens include pembrolizumab plus the CTLA-4 inhibitor quavonlimab, alone or with the multikinase inhibitor lenvatinib or ILT4 inhibitor MK-4830; pembrolizumab plus the LAG-3 inhibitor favezelimab; or R-DXd, a CDH6-targeted antibody–drug conjugate carrying a topoisomerase I inhibitor.
ClinicalTrials.gov ID: NCT04938817
