This has enabled successful clinical translation of targeted agents: PARP inhibitors for homologous recombination deficient (HRD) ovarian cancer, immune checkpoint inhibitors for mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) endometrial and cervical cancers, and antibody-drug conjugates (ADCs) like mirvetuximab soravtansine and tisotumab vedotin. Equitable access to these advances is imperative to prevent widening health disparities. The field is evolving towards a model of continuous molecular monitoring and adaptive therapy to improve outcomes.

23 days ago

Review • Journal • MSi-H Biomarker • PARP Biomarker • IO biomarker

MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)

MSI-H/dMMR

Elahere (mirvetuximab soravtansine-gynx) • Tivdak (tisotumab vedotin-tftv)

24d

An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients with Advanced Solid Tumor (ChiCTR2600120399)

P1, N=144, Recruiting, Cancer Hospital of Chinese Academy of Medical Sciences; Nanolattix Biotechnology Co., Ltd.

24 days ago

New P1 trial

Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (clinicaltrials.gov)

P1/2, N=350, Recruiting, Evopoint Biosciences Inc. | N=200 --> 350

1 month ago

Enrollment change • First-in-human

KEYNOTE-834: Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer (clinicaltrials.gov)

P1/2, N=214, Terminated, Seagen, a wholly owned subsidiary of Pfizer | Active, not recruiting --> Terminated; Sponsor has decided to stop the trial based on strategic decisions

1 month ago

Trial termination

Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Tivdak (tisotumab vedotin-tftv)

3ms

Evaluation of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors (clinicaltrials.gov)

P1, N=150, Not yet recruiting, Nanolattix Biotechnology Co., Ltd.

3 months ago

New P1 trial • First-in-human

3ms

innovaTV 301: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)

P3, N=502, Completed, Seagen, a wholly owned subsidiary of Pfizer | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Jan 2026

3 months ago

Trial completion • Trial completion date

gemcitabine • pemetrexed • irinotecan • vinorelbine tartrate • topotecan • Tivdak (tisotumab vedotin-tftv)

3ms

Antibody-Drug Conjugates in Gynecologic Oncology: Advances, Challenges, and Future Directions. (PubMed, BioDrugs)

Currently, three ADCs have received Food and Drug Administration (FDA) approval for use in gynecologic malignancies: mirvetuximab soravtansine, tisotumab vedotin, and trastuzumab deruxtecan. Furthermore, the inherent complexities of these drugs and their mechanisms of action underscore the need for further research into the relevance of biomarkers, methods of therapy resistance, and the potential for re-utilization of payloads and targets later in the disease course. This review focuses on the mechanisms of action of ADCs, their developmental trajectory, successes in gynecologic cancers, emerging areas of investigation, the prospective landscape, and current challenges in the field.

3 months ago

Review • Journal

VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1) • CDH6 (Cadherin 6)

Enhertu (fam-trastuzumab deruxtecan-nxki) • Elahere (mirvetuximab soravtansine-gynx) • Tivdak (tisotumab vedotin-tftv)

4ms

Mechanistic Exploration and Clinical Impact of Tisotumab Vedotin-Related Adverse Effects: Integrating FAERS Data Mining, Network Pharmacology, Molecular Docking, and Real-World Evidence (ChiCTR2500114973)

P=N/A, N=20, Not yet recruiting, Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University

4 months ago

New trial

Tivdak (tisotumab vedotin-tftv)