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Trial Title:
A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors
NCT ID:
NCT06336148
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: 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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is an Open label Single dose study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open label
Intervention:
Intervention type:
Drug
Intervention name:
ACTM-838
Description:
Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b
Arm group label:
ACTM-838 Monotherapy
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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
2. 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 )
3. Eastern Cooperative Oncology Group (ECOG) 0-1
4. Adequate hematologic, hepatic, pulmonary, and cardiac function
5. CD4 count >500/mL at screening
6. Additional protocol defined inclusion criteria may apply
Exclusion Criteria:
1. 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.
2. 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]
3. Known history of cholelithiasis or urolithiasis
4. History of valvular disease, arterial aneurisms or arterial or venous malformation
5. Known active brain metastases
6. Documented active Salmonella infection or vaccination with Salmonella typhi within 6
months prior to investigational product dosing
7. Additional protocol defined inclusion/exclusion criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Mark Wong, Dr
Phone:
+61 2 9845 5200
Email:
mark.wong@sydney.edu.au
Facility:
Name:
Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Ganessan Kichenadasse, Dr
Phone:
+61 491 670 039
Email:
clinicaltrials@socru.org.au
Facility:
Name:
Alfred Hospital, 55 Commercial Road, Site No: 201
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Andrew Haydon, Dr
Phone:
+61 3 9076 3129
Email:
andrew.haydon@monash.edu.au
Start date:
June 5, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Actym Therapeutics, Inc.
Agency class:
Industry
Source:
Actym Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06336148