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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06597721




Registration number
NCT06597721
Ethics application status
Date submitted
12/09/2024
Date registered
19/09/2024
Date last updated
19/09/2024

Titles & IDs
Public title
AMT-754 in Patients With Selected Advanced Solid Tumours
Scientific title
First-in-Human, Phase 1 Study of AMT-754, a Targeting Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
AMT-754-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMT-754

Experimental: AMT-754 Dose Escalation -


Treatment: Drugs: AMT-754
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [1] 0 0
Up to 24 months
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
Up to 24 months
Primary outcome [3] 0 0
Type, incidence and severity of Adverse Events
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR) according to the RECIST v1.1
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Concentration of anti-drug antibodies (ADA)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Maximum observed concentration (C[max])
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
Area under the curve (AUC)
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Terminal half-life (t[1/2])
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Time to maximum concentration (Tmax)
Timepoint [8] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peninsula and Southeast Oncology (PASO) - Frankston
Recruitment postcode(s) [1] 0 0
- Frankston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Multitude Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/study/NCT06597721
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jane Zhu
Address 0 0
Country 0 0
Phone 0 0
13917933915
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06597721