NCT06336148

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 Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2024

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 5, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

March 22, 2024

Last Update Submit

October 14, 2025

Conditions

Solid Tumor

Keywords

non-small cell lung cancerhead and neck canceresophageal cancerovarian cancercervical cancerstomach cancerthyroid cancerrenal cell cancermesotheliomabreast cancerpancreatic cancercolorectal cancersarcomaimmunotherapymelanomabladder cancercholangiocarcinomabile duct cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

ACTM-838 Monotherapy

EXPERIMENTAL

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

Interventions

ACTM-838DRUG

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

ACTM-838 Monotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

Los Angeles, California, 90033, United States

Location

UPMC Hillman Cancer Center, 5115 Centre Ave

Pittsburgh, Pennsylvania, 15232, United States

Location

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

Westmead, New South Wales, 2145, Australia

Location

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

Bedford Park, South Australia, 5042, Australia

Location

Alfred Hospital, 55 Commercial Road, Site No: 201

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungHead and Neck NeoplasmsEsophageal NeoplasmsOvarian NeoplasmsUterine Cervical NeoplasmsStomach NeoplasmsThyroid NeoplasmsCarcinoma, Renal CellMesotheliomaBreast NeoplasmsPancreatic NeoplasmsColorectal NeoplasmsSarcomaMelanomaUrinary Bladder NeoplasmsCholangiocarcinomaBile Duct Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesStomach DiseasesThyroid DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenomaNeoplasms, MesothelialBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPancreatic DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Connective and Soft TissueNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsUrinary Bladder DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is an Open label Single dose study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 28, 2024

Study Start

June 5, 2024

Primary Completion

August 28, 2025

Study Completion

August 28, 2025

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)US(2)