To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?