A Phase III randomized multi-site open-label trial of BNT323/DB-1303 versus investigator s choice of chemotherapy in previously treated patients with HER2-expressing recurrent endometrial cancer (GOG 3105)

Brief description of study

This is a Phase III study that is testing how well BNT323 works compared to a single chemotherapy drug chosen by the doctor. BNT323 is a special kind of treatment called an antibody-drug conjugate (ADC). It is designed to target HER2, a protein that is often found in higher amounts on the surface of certain cancer cells, like in endometrial cancer (a type of uterine cancer) and other cancers that express HER2. This study is for patients who have had treatment before and now have recurrent endometrial cancer (cancer that came back after previous treatment).

In this study, there are two cohorts: Cohort 1 and Cohort 2. Cohort 1 will include participants whose cancer has a HER2 score of 1+ or 2+ based on lab tests. Participants will be randomly assigned (2:1 ratio) to either receive BNT323 or a chemotherapy drug chosen by the doctor. The chemotherapy drugs will likely be doxorubicin or paclitaxel, or docetaxel if paclitaxel cannot be used. Treatment will continue until the cancer gets worse (based on RECIST 1.1 guidelines) or until there are unacceptable side effects or another reason to stop. Randomization will take into account the HER2 score (1+ vs 2+) and how many previous treatments the participant has had (1 treatment vs 2+ treatments). The main goal is to see how long people stay disease-free (without their cancer getting worse). This will be checked by a team of independent doctors. Cohort 2 will include participants whose cancer has a HER2 score of 3+ based on lab tests. Participants will receive BNT323 alone until the cancer gets worse (based on RECIST 1.1 guidelines), unless there are unacceptable side effects, they decide to stop, or another reason to stop the treatment happens. The main goal is to see how many people have positive results (cancer shrinks or improves). This will also be checked by an independent review team.

All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicines. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s23-01584
Principal Investigator: Whitfield B. Growdon.
Other Investigators: Anam Qureshi, Kent Chan, Cindy Corbo, Olivia Richardson Khouri, Sarah Saerohm Lee, Laura Palazzolo, Marina Stasenko, Jonathan B Kahn, Fabia Brisard Pierrot, Alexander A Hindenburg, Leslie R Boyd, Christina Grace Wilson, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Carol M Lee, Anastasiya Apanasyuk, Victoria Helen Dowd, Kelly A Levine, Rupal Bhana, Edward A Jimenez, Erin Annette Reese, Gabrielle Fridman, Sabrina Machado, Bhavana Pothuri, Kathleen M Lutz.


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