Clinical trial · Interventional
AMT-151 in Patients With Selected Advanced Solid Tumours
First-in-Human, Phase 1 Study of AMT-151, an Anti-Folate Receptor Alpha Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
NCT05498597CI-TRIAL-00070604unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (19)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Carcinoma | Carcinoma | CURATED_BROADER | 0.78 |
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Clear Cell Adenocarcinoma | Endometrial Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Endometrioid Adenocarcinoma | Endometrial Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Serous Adenocarcinoma | Endometrial Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Adenocarcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMT-151 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMT-151 Dose Escalation
- interventionNames
- Drug: AMT-151
Primary outcomes (3)
- measure
- Recommended Phase 2 Dose (RP2D)
- timeFrame
- Up to 24 months
- description
- The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- Up to 24 months
- description
- The MTD will be determined using DLTs
- measure
- Incidence of Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.