Brief Summary
This first-in-human study will evaluate the Maximum Tolerated Dosethe amount of medication taken (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advancedat a late stage, far along solid tumors.
Intervention / Treatment
- Drug: AMT-151
Inclusion Criteria:
- Patients must be willing and able to sign the Informed Consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. Form, and to adhere to the study visit schedule and other protocol requirements.
- Age ≥18 years (at the time consent is obtained).
- Patients with the following histologically confirmed, advanced cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs diagnoses:
- Serous, endometrioid, clear-cell, or mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Serous, endometrioid, or clear-cell endometrial cancer.
- Adenocarcinomacancer arising from mucus-producing glands in organs of the lung.
- Triple-negative breast cancer.
- Pancreatic ductal adenocarcinoma.
- Malignantcancerous, may grow and spread to other areas of the body pleural mesothelioma.
- Patients who have undergone any number of prior systemic therapies and have radiologically or clinically determined progressive disease during or after their most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
- Patients must have at least one measurable or non-measurable lesion as per RECIST version 1.1.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1.
- Adequate function of bone marrowsoft, spongy tissue found in bones that makes blood cells, liver, kidneys, heart.
- Both male and female patients must agree to use effective contraceptive methods.
- Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
- Availability of tumoura tissue mass that forms from groups of unhealthy cells tissuea group of cells that work together to perform a function sample (either an archival specimena sample for investigating (e.g. blood, stools, urine, sputum etc.) or a fresh biopsyremoval of a section of tissue to analyse for cancer cells material) at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.