APX005M and Doxorubicin in Advanced Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03719430|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Doxorubicin Drug: APX005M||Phase 2|
Doxorubicin, a chemotherapy, is currently considered standard-of-care treatment for most advanced soft tissue sarcomas. This study will assess the safety and efficacy of combining APX005M, a novel immunomodulatory drug, together with standard of care doxorubicin, for the treatment of patients with advanced soft tissue sarcoma. APX005M is an agonistic monoclonal antibody targeting the CD40 receptor and may have favorable effects on certain types of immune cells in sarcoma tumors, particularly macrophages.
The primary objective is to determine the objective response rate. Secondary objectives include further evaluation of safety and efficacy. A subset of patients will undergo tumor biopsies at baseline and while on study treatment to help understand how the drug combination works and to evaluate how the composition of immune cells in the tumor changes after the treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Evaluating APX005M (a CD40 Agonistic Monoclonal Antibody) in Combination With Standard-of-Care Doxorubicin for the Treatment of Advanced Sarcomas|
|Actual Study Start Date :||March 20, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2023|
Patients will be treated with doxorubicin and APX005M in 21 day cycles. All patients receive the same treatment (there is no "placebo" arm). After completing 8 cycles of study treatment, patients without evidence of disease progression or unacceptable toxicity may continue treatment with APX005M alone. Doxorubicin will not be continued beyond cycle 8 due to the risk for cardiac toxicity from cumulative dosing.
Doxorubicin is an anthracycline antibiotic with antineoplastic activity 75 mg/m2 IV day 1 (21 day cycles)
Other Name: ADRIAMYCIN
APX005M is a CD40 agonistic monoclonal antibody 0.3 mg/kg IV day 1 (21 day cycles)
Other Name: APX-005M
- Objective Response Rate [ Time Frame: 6 months ]The percentage of patients achieving a partial or complete response as measured by imaging assessments from study treatment
- Recommended Dose Combination for APX005M and Doxorubicin and Combination Treatment [ Time Frame: 6 months ]A safety-lead in phase will be conducted during which a small number of patients will be treated and monitored closely for certain side effects. If these side effects are seen, the dose of doxorubicin will be adjusted and the study treatment reassessed among another small number of patients. The purpose of the safety lead-in phase is to establish a safe and tolerable dose combination ("the recommended dose") which will be used during the remainder of the study.
- Evaluation of Side Effects from APXO05M and Doxorubicin Treatment [ Time Frame: 18 months ]Patients on the study will be assessed at regular intervals during clinical visits and through laboratory testing to monitor side effects from the study treatment.
- Progression Free Survival [ Time Frame: 18 months ]The mean time to either disease progression or death, whichever comes first, for patients on the study
- Changes in Immune Cell Infiltrates in Baseline and On-Study Biopsies [ Time Frame: 18 months ]Correlative/Exploratory Study
- Expression of CD40 in Baseline Study Biopsies [ Time Frame: 18 months ]Correlative/Exploratory Study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719430
|Contact: Lisa Olmosemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Matthew Ingham, MD firstname.lastname@example.org|
|Principal Investigator:||Matthew Ingham, MD||Columbia University|