A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06336148
• Other study ID #: ACTM-838-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Actym Therapeutics, Inc.
• Contact: Actym Therapeutics Trial Support
• Phone: +1 510-256-7167
• Email: ClinicalOperations[@]actymthera.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study has 2 parts. Part 1a will evaluate the safety and tolerability and activity of escalating doses of ACTM-838 to estimate the maximum tolerated dose (MTD) and/or the optimum biological dose (OBD) for ACTM-838 as a monotherapy and determine the dose recommended for Part 1b.

Part 1b will further evaluate ACTM-838 in patients with advanced specific tumor types (defined pathologically, clinically and/or molecularly) based on data emerging from the Phase 1a and the pre-clinical program.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: July 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• ACTM-838
Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b

Locations

Country	Name	City	State
Australia	Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202	Bedford Park	South Australia
Australia	Alfred Hospital, 55 Commercial Road, Site No: 201	Melbourne	Victoria
Australia	Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Actym Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

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