Evaluating AMT-116 for advanced solid tumors

Phase 1/2 Study of AMT-116 in Patients with Advanced Solid Tumors

This study is testing a new treatment called AMT-116 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Multitude Therapeutics Inc. (industry)
• Drugs / interventions: radiation
• Locations: 7 sites (Fuzhou, Fujian and 6 other locations)
• Trial ID: NCT06782334 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of AMT-116 as a monotherapy in patients with advanced solid tumors. It consists of two parts: the first part focuses on dose escalation to determine the optimal dosage, while the second part involves expansion to further evaluate the treatment's effectiveness. Participants will be closely monitored for any adverse effects and treatment responses throughout the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable advanced solid tumors that have progressed after standard therapies.

Not a fit: Patients with resectable tumors 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: While this approach is being explored in this specific context, similar studies have shown promise in targeting advanced solid tumors with novel therapies.

Eligibility criteria

Inclusion Criteria:

1. Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
2. Age ≥18 years (at the time consent is obtained).
3. Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include non-small cell lung, head and neck, esophageal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.
4. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
5. Patients must have at least one measurable lesion as per RECIST version 1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. The anticipated survival duration is no less than three months.
8. Patients must have adequate organ function
9. Women of child-bearing potential (WCBP) must consent to the use of two effective contraceptive methods during the study treatment period and for at least 12 weeks after the final administration of IMP
10. Women of child-bearing potential (WCBP) must have a negative serum pregnancy test within seven days preceding the initial administration of the investigational medicinal product (IMP).
11. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.
12. Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.
13. Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

Exclusion Criteria:

1. Prior therapy with ADC based on Top1 inhibitor.
2. Central nervous system (CNS) metastasis.
3. Active or chronic skin disorder requiring systemic therapy.
4. History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
5. Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.
6. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1.
7. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
8. Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., \> 30% of marrow-bearing bones) within 28 days.
9. Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.
10. Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.
11. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, etc.).
12. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.
13. Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV).
14. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
15. Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment.
16. Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
17. Known or suspected intolerance to the components of the IMP.
18. Concurrent participation in another investigational therapeutic clinical trial.
19. Patients with known active alcohol or drug abuse.
20. Pregnant or breast-feeding females.
21. Mental or medical disorders that prevent patients from signing informed consent or complying with the study, or other severe acute or chronic medical or psychiatric disorders or abnormal laboratory results that may increase the risk associated with study participation or IMP administration or may interfere with the interpretation of study results and, in the investigator's judgment, make patients ineligible for enrollment in the study.
22. There was a history of malignant tumors other than the selected diagnosis within 5 years prior to the first administration of IMP

Where this trial is running

Fuzhou, Fujian and 6 other locations

• Fujian Cancer Hospital — Fuzhou, Fujian, China (RECRUITING)
• Dongguan People's Hospital — Dongguan, Guangdong, China (NOT_YET_RECRUITING)
• Zhujiang Hospital of Southern Medical University(The Second Clinical Medical College) — Guangzhou, Guangdong, China (RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)
• Zhejiang cancer hospital — Hangzhou, Zhejiang, China (RECRUITING)
• The Second Affiliated Hospital and Yuying Childrens Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Yixuan Wang

Conditions: Advanced Solid Tumors