AMT-754 in Patients With Selected Advanced Solid Tumours

Trial Title: AMT-754 in Patients With Selected Advanced Solid Tumours

NCT ID: NCT06597721

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: AMT-754
Description: Administered intravenously
Arm group label: AMT-754 Dose Escalation

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-754, in Patients with Advanced Solid Tumors

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: - Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements. - Age ≥18 years (at the time consent is obtained). - Patients with pathologically confirmed unresectable advanced solid tumor. Preferred tumor types include cervical, head and neck squamous cell carcinoma, esophageal, endometrial, ovarian, lung, cholangiocarcinoma, colon and pancreatic cancer. - 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 (that is known to confer clinical benefit) is available, or who are intolerable to standard therapy. - Patients must have at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). - ECOG performance status of 0-1. - Life expectancy ≥3 months. - Patients must have adequate organ function. - Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use two effective contraceptive methods (examples include oral, parenteral, or implantable hormonal contraceptive, intra-uterine device, barrier contraceptive with spermicide, partner's latex condom or vasectomy) while on study treatment and for at least twelve weeks after the last dose of the IMP. - WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP. - Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP. - 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. - Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at screening. Key Exclusion Criteria: - Prior treatment with any agent targeting tissue factor. - CNS metastasis. - History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome. - 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 first dose of the IMP. - 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. - Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention. - 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 (SBP ≥ 160mmHg or DBP ≥ 100mmHg), uncontrolled cardiac arrhythmias. - Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis. - 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. - Acute and/or clinically significant bacterial, fungal or viral infection including HBV, HCV, and known HIV. - Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP. - Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment. - Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies. - Known or suspected intolerance to the components of the IMP. - Concurrent participation in another investigational therapeutic clinical trial. - Patients with known active alcohol or drug abuse. - Pregnant or breast-feeding females. - Mental or medical conditions that prevent the patient from giving informed consent or complying with the trial or other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the IMP administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study. - Prior history of malignancy other than inclusion diagnosis within five years prior to first dose of the IMP.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Peninsula and Southeast Oncology (PASO)

Address:
City: Frankston
Country: Australia

Contact:
Last name: Ganju Vinod

Phone: 61397815244
Email: vg@paso.com.au

Start date: October 1, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Multitude Therapeutics Inc.
Agency class: Industry

Source: Multitude Therapeutics Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06597721