A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors

Bookmark
High burden on patient More information

Trial Details

Sponsor: Actym Therapeutics, Inc. (industry)

Phase: 1

Start date: June 5, 2024

Planned enrollment: 35

Trial ID: NCT06336148
Copy trial ID
More trial details at ClinicalTrials.gov More info

chevron Show Summary from Sponsor

Investigational Drug AI Analysis

No investigational drugs.

HealthScout AI Analysis

Goal: The trial aims to evaluate the safety, tolerability, and preliminary antitumor activity of the investigational agent ACTM-838 as a single-agent therapy in patients with advanced solid tumors who have exhausted standard of care options. The study is designed to establish the maximum tolerated or optimal biological dose, and to further characterize the efficacy and safety profile in specific tumor types.

Patients: Eligible participants are adults with advanced solid tumors, for which no standard curative therapies remain or who are unwilling or unsuitable to receive them. Patients must have at least one measurable lesion by RECIST v1.1, ECOG performance status 0-1, adequate organ function, and CD4 counts >500/mL. Exclusion criteria include active autoimmune disease requiring systemic therapy, implants, cholelithiasis or urolithiasis, active brain metastases, certain infections, or recent live Salmonella typhi vaccination.

Design: This is a multicenter, open-label, non-randomized, dose-escalation (3+3 design expected) and dose-expansion phase 1a/1b study. The dose escalation phase (Part 1a) will establish dosing, while the expansion phase (Part 1b) will evaluate the chosen dose in defined tumor subpopulations.

Treatments: The only therapy under investigation is ACTM-838, administered as monotherapy. ACTM-838 is a novel agent; detailed mechanism of action and preclinical efficacy have not been provided, but as a first-in-human study, no clinical outcomes are available yet. The expansion cohort will help further delineate its antitumor effects, pharmacokinetics, pharmacodynamics, and immunogenicity.

Outcomes: Primary outcomes are the incidence and severity of adverse events as well as the proportion of participants experiencing dose-limiting toxicities in the first 28 days. Secondary endpoints include objective response rate (CR or PR), confirmed ORR, clinical benefit rate (CR, PR, or SD), duration of response, progression-free survival, changes in tumor markers, pharmacokinetics (ACTM-838 levels in blood, urine, and feces), intratumoral colonization and payload delivery (by ddPCR and RNA detection), and incidence of antidrug antibodies.

Burden on patient: The patient burden is expected to be high for this phase 1 study. Participants will likely undergo frequent clinic visits for safety monitoring, intensive pharmacokinetic and pharmacodynamic blood draws, serial imaging with CT or MRI, and mandatory tumor biopsies for correlative studies. In addition, adverse event monitoring and frequent laboratory assessments are required, potentially increasing travel and time spent in clinic compared to standard care.

Eligibility More information

chevron Show Criteria

Sites (5)

Sort by distance to:
Clear

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

Westmead, New South Wales, 2145, Australia

No email / No phone

Status: Completed

Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202

Bedford Park, South Australia, 5042, Australia

No email / No phone

Status: Completed

Alfred Hospital, 55 Commercial Road, Site No: 201

Melbourne, Victoria, 3004, Australia

No email / No phone

Status: Completed

University of Southern California Norris Comprehensive Cancer Center, 1441 Eastlake Ave.

Los Angeles, California, 90033, United States

[email protected] / 323-865-3000

Status: Recruiting

UPMC Hillman Cancer Center, 5115 Centre Ave

Pittsburgh, Pennsylvania, 15232, United States

[email protected] / 412-623-2294

Status: Recruiting

Back to trials list