Sacituzumab tirumotecan

HealthScout AI summary: For adults with pMMR advanced or recurrent endometrial carcinoma who have not progressed after first-line chemoimmunotherapy (carboplatin/taxane plus pembrolizumab), this trial randomizes maintenance pembrolizumab with or without sacituzumab tirumotecan. Sacituzumab tirumotecan is a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06952504

HealthScout AI summary: Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer after ≥4 cycles first-line platinum and 6 cycles second-line carboplatin doublet (ECOG 0–1) randomized to maintenance sacituzumab tirumotecan (TROP2-directed antibody–drug conjugate delivering a belotecan-derived topoisomerase I inhibitor) with optional bevacizumab versus standard-of-care maintenance with optional bevacizumab. Excludes platinum-resistant/refractory and non-epithelial/borderline histologies and patients with significant ocular disease, active IBD, uncontrolled CV/cerebrovascular disease, prior severe ILD/pneumonitis, or active CNS metastases.

ClinicalTrials.gov ID: NCT06824467

HealthScout AI summary: This trial enrolls adults with previously untreated, locally recurrent unresectable or metastatic triple-negative breast cancer with PD-L1 CPS <10, randomizing them to sacituzumab tirumotecan (a TROP2-directed antibody-drug conjugate), sacituzumab tirumotecan plus pembrolizumab (a PD-1 inhibitor), or standard chemotherapy. Eligible patients must be chemotherapy candidates without active CNS metastases or major comorbidities.

ClinicalTrials.gov ID: NCT06841354

HealthScout AI summary: First-line study in adults with HER2-negative (or not known positive) unresectable/metastatic gastric/GEJ/esophageal adenocarcinoma (ECOG 0–1) comparing pembrolizumab plus fluoropyrimidine/oxaliplatin chemotherapy versus the same backbone combined with sacituzumab tirumotecan (MK-2870), a TROP2-directed antibody–drug conjugate delivering a belotecan-derived topoisomerase I inhibitor. Safety lead-in determines RP2D, then randomized assessment of response, PFS, and OS.

ClinicalTrials.gov ID: NCT06469944

HealthScout AI summary: Adults with unresectable locally advanced or metastatic gastric/GEJ/esophageal adenocarcinoma after exactly one prior platinum/fluoropyrimidine regimen (HER2-negative or unknown) are randomized to sacituzumab tirumotecan (TROP2-directed ADC with a topoisomerase I payload) plus paclitaxel versus standard ramucirumab plus paclitaxel. Excludes squamous histology and patients with significant comorbidities (e.g., grade ≥2 neuropathy, ocular surface disease, active CNS mets, recent arterial events, prior VEGF/VEGFR therapy, or prior TROP2/topo I ADCs).

ClinicalTrials.gov ID: NCT06445972

HealthScout AI summary: Adults with recurrent or metastatic cervical squamous/adenocarcinoma after exactly one prior platinum doublet (±bevacizumab) and prior PD-1/PD-L1 therapy, ECOG 0–1, and measurable disease are randomized to sacituzumab tirumotecan (TROP2-directed ADC with topoisomerase I payload) versus physician’s choice of single-agent chemotherapy (pemetrexed, tisotumab vedotin, topotecan, vinorelbine, gemcitabine, or irinotecan). Primary efficacy focuses on overall survival in TROP2-high and all-comer populations.

ClinicalTrials.gov ID: NCT06459180

HealthScout AI summary: Adults with unresectable/metastatic GI cancers—previously treated colorectal or pancreatic ductal adenocarcinoma, and biliary tract cancers (treatment‑naive or previously treated)—receive sacituzumab tirumotecan (MK‑2870), a TROP2‑targeted antibody–drug conjugate delivering a belotecan‑derived topoisomerase I inhibitor, as monotherapy or combined with 5‑FU/leucovorin, or with cisplatin plus pembrolizumab. Excludes significant ophthalmologic disease and prior steroid‑requiring ILD/pneumonitis; prior therapy toxicities must have resolved.

ClinicalTrials.gov ID: NCT06428409

HealthScout AI summary: This trial enrolls adults with advanced, EGFR-mutated, non-squamous NSCLC who have progressed after prior EGFR TKI therapy, randomizing them to either sacituzumab tirumotecan (a TROP2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor) or standard platinum-based chemotherapy with pemetrexed and carboplatin.

ClinicalTrials.gov ID: NCT06305754

HealthScout AI summary: This trial enrolls adults with previously untreated, metastatic squamous non-small cell lung cancer (ECOG 0-1) who receive induction with pembrolizumab plus carboplatin and paclitaxel or nab-paclitaxel, then are randomized at maintenance to pembrolizumab alone or in combination with sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate linked to a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06422143

HealthScout AI summary: Adults with unresectable/metastatic gastric, GEJ, or esophageal adenocarcinoma after ≥2 prior systemic regimens (ECOG 0–1; HER2 status unrestricted) are randomized to sacituzumab tirumotecan (MK-2870), a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor, versus physician’s choice of trifluridine–tipiracil, irinotecan, paclitaxel, or docetaxel. Excludes prior TROP2 or topo I ADC/chemotherapy and active CNS disease; primary endpoint is overall survival.

ClinicalTrials.gov ID: NCT06356311

HealthScout AI summary: This trial enrolls adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have progressed on at least one prior endocrine therapy (including a CDK4/6 inhibitor), randomizing them to sacituzumab tirumotecan (a TROP2-directed antibody-drug conjugate), sacituzumab tirumotecan plus pembrolizumab (anti-PD-1), or physician’s choice of standard single-agent chemotherapy. Key exclusions include prior chemotherapy for metastatic disease and active autoimmune conditions.

ClinicalTrials.gov ID: NCT06312176

HealthScout AI summary: This trial enrolls adults with previously untreated metastatic NSCLC (non-squamous or squamous) and high PD-L1 expression (TPS ≥50%) without EGFR, ALK, or ROS1 alterations, comparing pembrolizumab monotherapy to pembrolizumab plus sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate linked to a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06170788

HealthScout AI summary: This trial enrolls adults with advanced or metastatic nonsquamous NSCLC with EGFR mutations or other actionable genomic alterations who have progressed after EGFR TKI and platinum chemotherapy, randomizing them to sacituzumab tirumotecan (an anti-TROP2 antibody-drug conjugate with a topoisomerase I inhibitor payload) versus standard chemotherapy (docetaxel or pemetrexed). Eligible patients must have good performance status (ECOG 0-1).

ClinicalTrials.gov ID: NCT06074588

HealthScout AI summary: Adults with metastatic or unresectable esophageal squamous cell carcinoma who progressed after one prior platinum regimen that included PD‑1/PD‑L1 therapy; compares standard second-line paclitaxel or irinotecan versus investigational sacituzumab tirumotecan (TROP2-directed topoisomerase I ADC), with previously planned pembrolizumab/MK‑4830 combinations closed to enrollment. Primary focus is safety and objective response with blinded central review, with secondary endpoints including PFS and OS.

ClinicalTrials.gov ID: NCT05319730