Evaluating AMT-151 for advanced solid tumors
First-in-Human, Phase 1 Study of AMT-151, an Anti-Folate Receptor Alpha Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
This study is testing a new treatment called AMT-151 to see if it can safely help people with certain advanced cancers that haven't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Multitude Therapeutics Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 9 sites (Sydney, New South Wales and 8 other locations) |
| Trial ID | NCT05498597 on ClinicalTrials.gov |
What this trial studies
This first-in-human trial assesses the safety, tolerability, and anti-tumor activity of AMT-151, a novel antibody-drug conjugate targeting folate receptor alpha, in patients with selected advanced solid tumors. The study aims to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) while also evaluating pharmacokinetics, pharmacodynamics, and immunogenicity. Eligible patients include those with specific advanced cancers who have experienced disease progression after prior therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific advanced cancers who have progressive disease after previous treatments.
Not a fit: Patients with early-stage cancers or those who have not yet undergone systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: Other studies involving antibody-drug conjugates have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Sydney, New South Wales and 8 other locations
- Chris O'Brien Lifehouse — Sydney, New South Wales, Australia (Recruiting)
- ICON Cancer Centre — Brisbane, Queensland, Australia (Recruiting)
- Mater Cancer Care Centre — South Brisbane, Queensland, Australia (Recruiting)
- Cancer Research SA — Adelaide, South Australia, Australia (Recruiting)
- Cabrini Malvern Hospital — Malvern, Victoria, Australia (Recruiting)
- One Clinical Research (OCR) — Perth, Western Australia, Australia (Recruiting)
- Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
- Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
- Shanghai Tumor Hospital — Shanghai, Shanghai, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Sarwan Bishnoi — Cancer Research SA
- Study coordinator: Jane Zhu
- Email: juanjuan.zhu@multitudetherapeutics.com
- Phone: 13917933915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.