Solid TumorPhase 1NCT06336148
A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors
A Phase 1 study testing ACTM-838 in people with Solid Tumor, run by Actym Therapeutics, Inc. at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ACTM-838
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 5 Jun 2024to 28 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia3 sites
Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202
Bedford Park, South Australia, 5042
Alfred Hospital, 55 Commercial Road, Site No: 201
Melbourne, Victoria, 3004
Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200
Westmead, New South Wales, 2145
United States2 sites
University of Southern California Norris Comprehensive Cancer Center, 1441 Eastlake Ave.
Los Angeles, California, 90033
UPMC Hillman Cancer Center, 5115 Centre Ave
Pittsburgh, Pennsylvania, 15232
About this study
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
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.
Read the detailed 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. The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment.
- Conditions
- Solid Tumor
- Being tested
- ACTM-838
- Keywords
- non-small cell lung cancer, head and neck cancer, esophageal cancer, ovarian cancer, cervical cancer, stomach cancer, thyroid cancer, renal cell cancer, mesothelioma, breast cancer, pancreatic cancer, colorectal cancer, sarcoma, immunotherapy, melanoma, bladder cancer, cholangiocarcinoma, bile duct cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Esophageal Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Stomach Neoplasms, Thyroid Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTM-838Drug
Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ACTM-838 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events and serious adverse events - Part 1a
Measured: 1 year
Proportion of participants experiencing dose limiting toxicities - Part 1a
Measured: 28 Days
Secondary outcomes (9)
Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a
Measured: 1 year
Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a
Measured: 1 year
Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a
Measured: 1 year
Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a
Measured: 1 year
Progression free survival (PFS) - Part 1a
Measured: 1 year
Change in tumor markers - Part 1a
Measured: 1 year
Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a
Measured: 1 year
Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a
Measured: 1 year
Incidence of antidrug antibodies (ADA) to ACTM-838 - Part 1a
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start5 Jun 2024
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Why it stopped: Sponsor's strategic business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an Open label Single dose study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actym Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336148
- Sponsor's protocol ID
- ACTM-838-01
- Status last verified
- Oct 2025
- First submitted
- 22 Mar 2024
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06336148
- Acronym / sponsor ID
- ACTM-838-01
- Conditions
- Solid Tumor
- Keywords
- non-small cell lung cancer, head and neck cancer, esophageal cancer, ovarian cancer, cervical cancer, stomach cancer, thyroid cancer, renal cell cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's strategic business decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Actym Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an Open label Single dose study.
| Arm | Type | Receives |
|---|---|---|
| ACTM-838 Monotherapy | Experimental | Drug: ACTM-838Escalating doses of ACTM-838 in Part 1a followed by expansion in Part 1b at the recommended dose determined in Part 1a |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTM-838Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b | Drug | ACTM-838 Monotherapy |
Primary outcome
Incidence and severity of adverse events and serious adverse events - Part 1a
Time frame: 1 year
Proportion of participants experiencing dose limiting toxicities - Part 1a
Time frame: 28 Days
9 secondary outcomes
Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a
Time frame: 1 year
Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a
Time frame: 1 year
Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a
Time frame: 1 year
Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a
Time frame: 1 year
Progression free survival (PFS) - Part 1a
Time frame: 1 year
Change in tumor markers - Part 1a
Time frame: 1 year
Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a
Time frame: 1 year
Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a
Time frame: 1 year
Incidence of antidrug antibodies (ADA) to ACTM-838 - Part 1a
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Sponsor's strategic business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACTM-838 in people with Solid Tumor, run by Actym Therapeutics, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's strategic business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events and serious adverse events - Part 1a (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.