PHST001-101 is a Phase 1 clinical study of PHST001, an investigational drug (a drug that is still being tested), in adults with advanced solid tumors. This study looks at how safe PHST001 is, how the body processes it, and early signs of activity against tumors. Some study groups may receive PHST001 together with anti-cancer therapies, including U.S. Food and Drug Administration (FDA)-approved antibody-drug conjugates (ADCs) and chemotherapies.
Study groups include adults with:
Some cancer cells hide from the immune system using a signal called CD24. PHST001 is designed to block that signal and help immune cells find cancer cells. This study looks at how safe PHST001 is and how the body handles it.
In this open-label study, everyone knows which medicines they get. Study groups include ovarian cancer, endometrial cancer, and HER2-low breast cancer. Some groups get PHST001 with other cancer medicines.
Only a study doctor can decide who can take part. You can find who can join, where the study sites are, and how to contact them on ClinicalTrials.gov.
Taking part in a clinical study is voluntary, and participants can leave the study at any time. Investigational drugs may cause side effects. The study team will explain possible risks before an individual decides to take part.
We know you may have questions and we are grateful for your interest. Pheast runs this study, but we cannot answer questions about whether you can join. We also cannot give medical advice. Your doctor and the study team at each site can help you.
Want to learn about getting our study drugs outside of a clinical trial? See our Compassionate Use / Expanded Access policy.
Pheast Therapeutics is a clinical-stage oncology company developing antibody therapeutics designed to restore immune recognition of cancer.
To learn more about our science and PHST001’s FDA Fast Track Designation, visit our pipeline page.
This open-label study includes adults with advanced solid tumors. Their cancer came back or stopped responding to usual treatment. The study includes groups for ovarian cancer, endometrial cancer, and HER2-low breast cancer.
The study includes groups for adults with advanced ovarian cancer. Their cancer came back or stopped responding to usual treatment. In these groups, PHST001 may be given with one of these chemotherapy medicines:
In one group, people are chosen by chance to get either Elahere® alone or Elahere® with PHST001. Elahere® (mirvetuximab soravtansine) is an FDA-approved antibody-drug conjugate (ADC).
The study includes a group for adults with advanced endometrial cancer. Their cancer came back or stopped responding to usual treatment. In this group, PHST001 may be given with the chemotherapy medicine paclitaxel or doxorubicin.
The study includes a group for adults with advanced or metastatic HER2-low breast cancer. In this group, PHST001 may be given together with trastuzumab deruxtecan (Enhertu®), an FDA-approved antibody-drug conjugate (ADC). HER2-low is a type of breast cancer. Your doctor can tell you if this applies to you. Only a study doctor can confirm if a specific type of breast cancer fits the study.
An antibody-drug conjugate, or ADC, is a type of cancer medicine made of two parts joined together: an antibody and a cancer-fighting drug.
The antibody works like a guide. It is designed to find and attach to a specific marker on cancer cells, so it can carry the drug more directly to those cells.
In this study, the ADCs that may be given together with PHST001 are FDA-approved medicines: mirvetuximab soravtansine (Elahere®) in an ovarian cancer group and trastuzumab deruxtecan (Enhertu®) in the breast cancer group.
Chemotherapy is a type of medicine that attacks cells that grow and divide quickly, such as cancer cells.
“Standard of care” means a treatment that doctors commonly use for a certain type of cancer.
The chemotherapy used depends on the study group. It may be:
Your doctor can explain what each treatment involves.
Study visits may take place alongside regular cancer care. PHST001 is given by IV (intravenous infusion), which means the medicine goes into a vein through a small tube. Study visits take place at participating study sites. You can find the list of sites on ClinicalTrials.gov. More information about what taking part may involve, such as how often visits happen, can be discussed with your doctor.
PHST001 is an investigational drug being studied in a clinical trial. It has not been approved by the FDA or any other government agency that approves medicines. We do not yet know if it is safe or if it works.
This page is for educational purposes only and is not medical advice. Please talk with your doctor about whether a clinical trial may be right for you.
We know you may have questions and we are grateful for your interest. Pheast runs this study, but we cannot answer questions about whether you can join. We also cannot give medical advice. Your doctor and the study team at each site can help you.
For study information, please contact a participating study site listed on ClinicalTrials.gov.
Want to learn about getting our study drugs outside of a clinical trial? See our Compassionate Use / Expanded Access policy.
Participating sites are listed below. Site locations may change. See ClinicalTrials.gov for the current list.
PHST001-101 study page · Version [1.0] · [Submission date]
PHST001 is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. This page is for educational purposes only and is not medical advice.
Links to ClinicalTrials.gov and the National Cancer Institute are provided for information only. Pheast is not responsible for the content of external websites.
PHEAST THERAPEUTICS™ and the PHEAST logo are trademarks of Pheast Therapeutics, Inc. ELAHERE® is a registered trademark of ImmunoGen, Inc., an AbbVie company. ENHERTU® is a registered trademark of Daiichi Sankyo Company, Limited. All other trademarks are the property of their respective owners.