Brief Summary
This first-in-human study will evaluate the Maximum Tolerated Dose (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 Consent 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 cancer 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.
- Malignant 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 Oncology 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 tumour tissue sample (either an archival specimen or a fresh biopsyremoval of a section of tissue to analyse for cancer cells material) at screening.