Trial Review

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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/NCT06400485




Registration number
NCT06400485
Ethics application status
Date submitted
1/05/2024
Date registered
6/05/2024
Date last updated
23/05/2024

Titles & IDs
Public title
AMT-676 in Patients With Advanced Solid Tumors
Scientific title
First-in-Human, Phase 1 Study of AMT-676 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
AMT-676-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMT-676

Experimental: AMT-676 Dose escalation - Drug- AMT-676 Dosage level: AMT-676 will be administered as an intravenous (IV) infusion. Dosage form: Vial Route of administration: Intravenous Infusion


Treatment: Drugs: AMT-676
Participants will receive AMT-676 administered intravenously. Participants will be observed for first instance of dose limiting toxicities (DLT).
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
30 days after the last dose of IMP
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
30 days after the last dose of IMP
Primary outcome [3] 0 0
Type, incidence and severity of Adverse Events
Timepoint [3] 0 0
30 days after the last dose of IMP
Secondary outcome [1] 0 0
Maximum observed concentration (C[max])
Timepoint [1] 0 0
30 days after the last dose of IMP
Secondary outcome [2] 0 0
Time to maximum concentration (Tmax)
Timepoint [2] 0 0
30 days after the last dose of IMP
Secondary outcome [3] 0 0
Area under the curve (AUC)
Timepoint [3] 0 0
30 days after the last dose of IMP
Secondary outcome [4] 0 0
Terminal half-life (t[1/2])
Timepoint [4] 0 0
30 days after the last dose of IMP
Secondary outcome [5] 0 0
Concentration of anti-drug antibodies (ADA)
Timepoint [5] 0 0
30 days after the last dose of IMP
Secondary outcome [6] 0 0
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [6] 0 0
30 days after the last dose of IMP
Secondary outcome [7] 0 0
Disease Control Rate (DCR) according to the RECIST v1.1
Timepoint [7] 0 0
30 days after the last dose of IMP
Secondary outcome [8] 0 0
Progression-free Survival (PFS)
Timepoint [8] 0 0
30 days after the last dose of IMP

Eligibility
Key inclusion criteria
Key

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 pathologically confirmed unresectable advanced solid tumor. Preferred
tumor types include colorectal cancer, gastric cancer, esophageal adenocarcinoma,
cholangiocarcinoma, pancreatic ductal cancers, and neuroendocrine tumors.

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. Life expectancy =3 months.

8. Patients must have adequate organ function

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

10. 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.

11. 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.

12. 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
1. Prior treatment with any agent for the same target.

2. Central nervous system (CNS) metastasis

3. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.

4. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.

5. Systemic anti-neoplastic therapy within five half-lives or21 days, whichever is
shorter, prior to first dose of the IMP.

6. 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.

7. 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.

8. Significant cardiac disease, such as recent (within 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.

9. 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.) or other lung disease significantly impacting lung
function at baseline.

10. 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.

11. Acute and/or clinically significant bacterial, fungal or viral infection including
hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV)

12. Administration of a live vaccine within 28 days prior to the administration of the
first dose of the IMP.

13. Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome
P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and
during the study treatment.

14. Known or suspected severe allergy/hypersensitivity (resulting in treatment
discontinuation) to monoclonal antibodies.

15. Known or suspected intolerance to the components of the IMP.

16. Concurrent participation in another investigational therapeutic clinical trial.

17. Patients with known active alcohol or drug abuse.

18. Pregnant or breast-feeding females

19. 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 enrolment in this study.

20. 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
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 0
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
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/02/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,New South wWalesQLD,VIC,WA
Recruitment hospital [1] 0 0
SCIENTIA Clinical Research Ltd - Randwick
Recruitment hospital [2] 0 0
Macquarie University Hospital - Macquarie
Recruitment hospital [3] 0 0
Gallipoli Medical Research Foundation - Greenslopes
Recruitment hospital [4] 0 0
Cabrini Hospital - Melbourne
Recruitment hospital [5] 0 0
Linear Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Macquarie
Recruitment postcode(s) [3] 0 0
- Greenslopes
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study will evaluate
the Maximum tolerated dose (MTD)/the recommended Phase 2 Dose (RP2D), safety, tolerability,
anti-drug activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-676 in
Patients with Advanced Solid Tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06400485
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
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/NCT06400485