Mylotarg (gemtuzumab ozogamicin)

P=N/A, N=165, Recruiting, Pfizer | Trial completion date: Apr 2027 --> Jul 2027 | Trial primary completion date: Apr 2027 --> Jul 2027

P4, N=289, Recruiting, Medizinische Hochschule Hannover | N=128 --> 289

P4, N=128, Recruiting, Medizinische Hochschule Hannover | N=52 --> 128

P1, N=32, Not yet recruiting, M.D. Anderson Cancer Center | Initiation date: Dec 2025 --> Dec 2027

P2, N=162, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Feb 2026 --> Jun 2026

In the in vivo experiments, mice bearing Molm13-Luciferase tumor cells were assigned to different treatment groups and were administered with saline, Gemtuzumab-MMAE, or Clone3HM-MMAE...Clone3HM-MMAE, in particular, demonstrated excellent anti-tumor activity along with a strong safety profile. These results strongly support the further development of targeted therapeutic strategies for AML.

First-generation ADCs, such as Gemtuzumab ozogamicin, demonstrated the proof of concept but suffered from high immunogenicity, poor selectivity, and heterogeneous drug-antibody ratios. Second-generation ADCs introduced stable linkers and humanized antibodies, exemplified by Ado-trastuzumab emtansine (T-DM1), which targets the HER2 receptor in breast cancer...Third-generation ADCs, including Trastuzumab deruxtecan and Sacituzumab govitecan, incorporate site-specific conjugation, higher drug-to-antibody ratios, and potent payloads capable of inducing bystander killing even in tumors with low antigen expression...In conclusion, ADCs exemplify the convergence of molecular biology, immunology, and medicinal chemistry in the pursuit of precision oncology. Their progressive evolution from concept to clinic not only validates Ehrlich's century-old vision but also heralds a new therapeutic era in which cancer treatment achieves unprecedented specificity, efficacy, and improvement in patient outcomes.

P1, N=26, Completed, Baylor College of Medicine | Active, not recruiting --> Completed

This review compared the efficacy and safety of low-dose cytarabine (LDAC), azacitidine (AZA), 5- and 10-day decitabine (DEC), and gemtuzumab ozogamicin, alone or combined with drugs such as venetoclax (VEN), in older adults with AML ineligible for conventional chemotherapy. Treatment decisions should consider patient goals and functional status. These findings informed eight recommendations in updated ASH-AML guidelines.

These results support further evaluation of combination therapies with corresponding small-molecule inhibitors (currently pursued for therapy of other cancers) toward clinical testing as novel strategies to increase the efficacy of CLM-based ADCs such as GO and InO.

P2, N=19, Active, not recruiting, Centre Antoine Lacassagne | Recruiting --> Active, not recruiting | N=50 --> 19 | Trial completion date: Mar 2027 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2028

Twenty-five years ago, the FDA gave the first approval to an antibody-drug conjugate (ADC), the CD33-targeting gemtuzumab ozogamicin for acute myeloid leukemia. As the drug faced setbacks and redemption-it was withdrawn in 2010 following poor phase III trial results but reapproved in 2017 at a lower dose-a surge of pharmaceutical interest in ADCs has yielded newly approved agents and new strategies for developing them.