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

PHASE1RECRUITING

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.

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Study details:

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.

The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

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 )

Eastern Cooperative Oncology Group (ECOG) 0-1

Adequate hematologic, hepatic, pulmonary, and cardiac function

CD4 count >500/mL at screening

Additional protocol defined inclusion criteria may apply

Exclusion criteria

Active autoimmune disease requiring systemic treatment (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drug) within the past 6 months prior to dosing of investigational product.

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]

Known history of cholelithiasis or urolithiasis

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

Known active brain metastases

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

Additional protocol defined inclusion/exclusion criteria may apply

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-06-05

Primary completion: 2026-01-01

Study completion finish: 2026-07-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06336148

Intervention or treatment

DRUG: ACTM-838

Conditions

• Solid Tumor

Condition: Solid Tumor
DRUG: ACTM-838
Westmead, New South Wales, Australia and more
Sponsor: Actym Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200

Research sites nearby

Select from list below to view details:

Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200
Westmead, New South Wales, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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	DRUG: ACTM-838 Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence and severity of adverse events and serious adverse events - Part 1a	Not Specified	1 year
Proportion of participants experiencing dose limiting toxicities - Part 1a	Not Specified	28 Days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a	Not Specified	1 year
Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a	Not Specified	1 year
Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a	Not Specified	1 year
Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a	Not Specified	1 year
Progression free survival (PFS) - Part 1a	Not Specified	1 year
Change in tumor markers - Part 1a	Not Specified	1 year
Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a	Not Specified	1 year
Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a	Not Specified	1 year
Incidence of antidrug antibodies (ADA) to ACTM-838 - Part 1a	Not Specified	1 year

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

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