Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06336148
Other study ID # ACTM-838-01
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date April 2024
Est. completion date July 2026

Study information

Verified date March 2024
Source Actym Therapeutics, Inc.
Contact Actym Therapeutics Trial Support
Phone +1 510-256-7167
Email ClinicalOperations@actymthera.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 35
Est. completion date July 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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, and cardiac function 5. CD4 count >500/mL at screening Exclusion Criteria: 1. Current use of nonsteroidal anti-inflammatory drugs or COX-2 inhibitors 2. Active autoimmune disease requiring systemic treatment (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drug) within the past 2 years prior to dosing of investigational product. 3. 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] 4. History of cholelithiasis or urolithiasis 5. History of valvular disease, arterial aneurisms or arterial or venous malformation 6. Known brain metastases 7. Documented active Salmonella infection or vaccination with Salmonella typhi within 6 months prior to investigational product dosing 8. Additional protocol defined inclusion/exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Australia Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202 Bedford Park South Australia
Australia Alfred Hospital, 55 Commercial Road, Site No: 201 Melbourne Victoria
Australia Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200 Westmead New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Actym Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b 1 year
Primary Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b 28 Days
Primary Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b 1 year
Primary Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b 1 year
Primary Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b 1 year
Primary Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b 1 year
Primary Progression free survival (PFS) - Part 1b 1 year
Primary Change in tumor markers - Part 1b 1 year
Primary Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b 1 year
Secondary Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a 1 year
Secondary Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a 1 year
Secondary Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a 1 year
Secondary Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a 1 year
Secondary Progression free survival (PFS) - Part 1a 1 year
Secondary Change in tumor markers - Part 1a 1 year
Secondary Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a 1 year
Secondary Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05580991 - Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors Phase 1
Recruiting NCT05691608 - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 N/A
Active, not recruiting NCT02846038 - Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
Recruiting NCT05159388 - A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Recruiting NCT05981703 - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT06014502 - Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors Phase 1
Recruiting NCT04107311 - Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Active, not recruiting NCT04078152 - Durvalumab Long-Term Safety and Efficacy Study Phase 4
Completed NCT02250157 - A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies Phase 1
Recruiting NCT05566574 - A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT03943004 - Trial of DFP-14927 in Advanced Solid Tumors Phase 1
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Recruiting NCT05525858 - KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Recruiting NCT05798546 - Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02) Phase 1
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT00479128 - Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors Phase 1
Recruiting NCT04143789 - Evaluation of AP-002 in Patients With Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2