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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/NCT06336148




Registration number
NCT06336148
Ethics application status
Date submitted
22/03/2024
Date registered
28/03/2024
Date last updated
28/03/2024

Titles & IDs
Public title
A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors
Scientific title
A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
ACTM-838-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ACTM-838

Experimental: ACTM-838 Monotherapy - Escalating doses of ACTM-838 in Part 1a followed by expansion in Part 1b at the recommended dose determined in Part 1a


Treatment: Drugs: ACTM-838
Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b
Timepoint [2] 0 0
28 Days
Primary outcome [3] 0 0
Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b
Timepoint [3] 0 0
1 year
Primary outcome [4] 0 0
Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b
Timepoint [4] 0 0
1 year
Primary outcome [5] 0 0
Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b
Timepoint [5] 0 0
1 year
Primary outcome [6] 0 0
Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b
Timepoint [6] 0 0
1 year
Primary outcome [7] 0 0
Progression free survival (PFS) - Part 1b
Timepoint [7] 0 0
1 year
Primary outcome [8] 0 0
Change in tumor markers - Part 1b
Timepoint [8] 0 0
1 year
Primary outcome [9] 0 0
Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b
Timepoint [9] 0 0
1 year
Secondary outcome [1] 0 0
Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Progression free survival (PFS) - Part 1a
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Change in tumor markers - Part 1a
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a
Timepoint [8] 0 0
1 year

Eligibility
Key inclusion criteria
1. Advanced solid tumor for which there is no remaining standard curative therapy and no
therapy with a demonstrated survival benefit, or they must be ineligible to receive or
refuse to receive such therapy

2. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors
(RECIST ) v1.1; amenable for biopsy, and radiographically apparent on computed
tomography (CT) or magnetic resonance imaging (MRI )

3. Eastern Cooperative Oncology Group (ECOG) 0-1

4. Adequate hematologic, hepatic, and cardiac function

5. CD4 count >500/mL at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current use of nonsteroidal anti-inflammatory drugs or COX-2 inhibitors

2. Active autoimmune disease requiring systemic treatment (i.e., with use of disease
modifying agents, systemic corticosteroids or immunosuppressive drug) within the past
2 years prior to dosing of investigational product.

3. History of permanent artificial implants (e.g., prosthetic joints, artificial heart
valves, pacemakers, orthopaedic screw[s], metal plate[s], bone graft[s], or other
exogenous implant[s]

4. History of cholelithiasis or urolithiasis

5. History of valvular disease, arterial aneurisms or arterial or venous malformation

6. Known brain metastases

7. Documented active Salmonella infection or vaccination with Salmonella typhi within 6
months prior to investigational product dosing

8. Additional protocol defined inclusion/exclusion criteria may 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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200 - Westmead
Recruitment hospital [2] 0 0
Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202 - Bedford Park
Recruitment hospital [3] 0 0
Alfred Hospital, 55 Commercial Road, Site No: 201 - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid
tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and
Part 1b will evaluate dose expansion.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06336148
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
SVP, Clinical Development, MD, PhD
Address 0 0
Actym Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Actym Therapeutics Trial Support
Address 0 0
Country 0 0
Phone 0 0
+1 510-256-7167
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/ct2/show/NCT06336148