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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05725291




Registration number
NCT05725291
Ethics application status
Date submitted
2/02/2023
Date registered
13/02/2023
Date last updated
27/07/2023

Titles & IDs
Public title
AMT-116 in Patients With Advanced Solid Tumors
Scientific title
First-in-Human, Phase 1 Study of AMT-116 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
AMT-116-01
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-116

Experimental: AMT-116 Dose Escalation -


Treatment: Drugs: AMT-116
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 histologically confirmed, unresectable advanced solid tumor. Preferred
tumor types include head and neck, non-small cell lung, esophageal, pancreatic, large
cell lung, colorectal, cervical, breast, bladder, gastric, biliary tract, skin
squamous cell, liver, and basal cell 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 is available, or who are intolerable to
standard therapy.

- Patients must have at least one measurable lesion as per RECIST version 1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

- Both male and female patients must agree to use effective contraceptive methods.

- Patients must have adequate organ function.

- Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.

- 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.

- 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 tumour 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 therapy with ADC based on Top1 inhibitor.

- Central nervous system (CNS) metastasis.

- Active or chronic skin disorder requiring systemic therapy.

- History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.

- 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.

- 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 the first dose of the IMP, or no recovery from side effects of
such intervention.

- Prior allogeneic or autologous bone marrow transplantation.

- 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.

- Pregnant or breast-feeding females.

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
ICON Cancer Centre - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

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-116, in Patients with Advanced Solid Tumors
Trial website
https://clinicaltrials.gov/ct2/show/NCT05725291
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jermaine Coward
Address 0 0
ICON Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shuang Leng
Address 0 0
Country 0 0
Phone 0 0
+61 411818616
Fax 0 0
Email 0 0
shuang.leng@multitudetherapeutics.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05725291