Study of a New Treatment Called TNG348 in People with Advanced or Metastatic Cancer and with a BRCA1 or BRCA2 Mutation or HRD Positive Tumor

About the Study

The study will test the safety and effectiveness of a new drug called TNG348 used alone or in combination with Olaparib (a PARP inhibitor.) The study is for patients who have advanced breast, ovarian, pancreatic, and prostate cancer and a BRCA1 or BRCA2 mutation or have an HRD positive tumor.

What the Study Involves

This is an open-label, non-randomized study.

• All patients will receive the study drug TNG348 orally either alone or in combination with Olaparib, a PARP inhibitor.
• The study will have different groups of participants. Participants will be assigned to a group based on their type of cancer or tumor testing.
  • The dose escalation groups 1 and 2 will establish the ideal dose of TNG348 alone or in combination with Olaparib.
  • The dose expansion groups 3- 8 will include additional patient populations.  
  • All participants will keep taking the medication until their cancer gets worse, the treatment causes severe side effects, or they choose to stop the study.  

Participant groups:

Group 1:

• People with BRCA1, BRCA2 mutation or HRD positive tumor will receive increasing doses of TNG348 over 21 days.

Group 2:

• People with BRCA1, BRCA2 mutation or HRD positive tumor will receive increasing doses of TNG348 and Olaparib over 21 days.

Group 3

• People who have breast cancer and a BRCA1or BRCA2 mutation will receive the recommended doses of TNG348 over 56 days.

Group 4

• People who have ovarian cancer and a BRCA1or BRCA2 mutation will receive the recommended doses of TNG348 over 56 days.

Group 5

• People who have breast cancer and a BRCA1or BRCA2 mutation will receive the recommended doses of TNG348 and Olaparib over 56 days.

Group 6

• People who have ovarian cancer and a BRCA1 or BRCA2  mutation will receive the recommended doses of TNG348 and Olaparib over 56 days.

Group 7

• People who have pancreatic or prostate cancer and a BRCA1 or BRCA2 mutation will receive the recommended doses of TNG348 and Olaparib over 56 days.

Group 8

• People who have advanced solid cancers and an HRD positive tumor will receive the recommended doses of TNG348 and Olaparib over 56 days.

Study Sites

Colorado

Denver
HealthONE
Principal Investigator Gerald Falchook, MD  

Florida

Orange City
Mid Florida Cancer Centers
Principal Investigator: Santosh Nair, MD

Sarasota
Florida Cancer Specialists
Principal Investigator: Manish Patel, MD

Massachusetts

Boston
Dana Farber Cancer Institute
Principal Investigator: Alok Tewari, MD, PhD     

New York

New York
New York University Langone Health
Principal Investigator: Nancy Chan, MD

Texas

Houston
The University of Texas MD Anderson Cancer Center
Principal Investigator: Timothy Yap, MD, PhD 

People 18 years old and older, who meet all the following criteria.

• Advanced or metastatic breast, ovarian, pancreatic or prostate cancer solid tumor.
• BRC1, BRCA2 mutation or HRD positive tumor.
• Adequate organ and bone marrow function.

People under the age of 18 and who:

• Have known allergies, strong reactions, or can’t tolerate TNG348, Olaparib, and the ingredients with them.
• Have another illness that isn’t under control and make it difficult to follow the study rules.
• Are participating in other clinical trials.
• Have stomach or digestive issues or disease.
• Have brain metastasis.
• Have myelodysplastic syndromes (a group of disorders caused by blood cells that are poorly formed or don't work properly.)
• Have cardiovascular (heart) disease.
• Have an active or chronic infection.
• People who are pregnant or breastfeeding.