AMT-151 in Patients With Selected Advanced Solid Tumours

Multitude Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Malignant Pleural Mesothelioma

Endometrial Serous Adenocarcinoma

Ovarian Clear Cell Carcinoma

Ovarian Mucinous Adenocarcinoma

Ovarian Clear Cell Adenocarcinoma

Advanced Solid Tumor

Ovarian Epithelial Cancer

Ovarian Carcinoma

Advanced Carcinoma

Pancreatic Ductal Adenocarcinoma

Ovarian Cancer

Lung Adenocarcinoma

Endometrial Cancer

Advanced Cancer

Endometrial Adenocarcinoma

Endometrial Clear Cell Adenocarcinoma

Triple Negative Breast Cancer

Endometrial Endometrioid Adenocarcinoma

Ovarian Endometrioid Adenocarcinoma

Treatments

Drug: AMT-151

Study type

Interventional

Funder types

Industry

Identifiers

NCT05498597

AMT-151-01

Details and patient eligibility

About

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 advanced solid tumors.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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:
1. Serous, endometrioid, clear-cell, or mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
2. Serous, endometrioid, or clear-cell endometrial cancer.
3. Adenocarcinoma of the lung.
4. Triple-negative breast cancer.
5. Pancreatic ductal adenocarcinoma.
6. 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 marrow, 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 biopsy material) at screening.

Key Exclusion Criteria:

Prior treatment with any agent targeting Folate Receptor Alpha.
Active central nervous system metastasis.
Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to the first dose of the study drug.
Radiotherapy to lung field at a total radiation dose of >= 20 Gy within 6 months, wide-field radiotherapy (>30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
Prior allogeneic or autologous bone marrow transplantation.
Significant cardiac or lung disease, active or chronic ocular disorders, thromboembolic or cerebrovascular events within 6 months prior to the first dose of the study drug, acute and/or clinically significant bacterial, fungal, or viral infection.
Pregnant or breast-feeding females.

Note: Other protocol defined Inclusion/Exclusion criteria apply.