A Phase 1a/1b Study Of ACTM-838 In Patients With Advanced Solid Tumors

Study Overview

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

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.

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.

Solid Tumor

DRUG: ACTM-838

ACTM-838-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-03-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-10-14
First Submitted that Met QC Criteria 2024-03-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-10-15
First Posted (ESTIMATED) 2024-03-28	Results First Posted N/A	Last Verified 2025-10

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

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

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

Primary Outcome Measures	Measure Description	Time Frame
Incidence and severity of adverse events and serious adverse events - Part 1a		1 year
Proportion of participants experiencing dose limiting toxicities - Part 1a		28 Days

Secondary Outcome Measures	Measure Description	Time Frame
Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a		1 year
Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a		1 year
Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a		1 year
Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a		1 year
Progression free survival (PFS) - Part 1a		1 year
Change in tumor markers - Part 1a		1 year
Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a		1 year
Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a		1 year
Incidence of antidrug antibodies (ADA) to ACTM-838 - Part 1a		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record