A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed Refractory Multiple Myeloma

Study Purpose

This is an open-label, single-arm study of ATG-010 (selinexor) plus low-dose Dexamethasone (Sd) in patients with multiple myeloma previously treated with lenalidomide and bortezomib refractory to prior treatment with immunomodulatory agents and proteasome Inhibitors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Written informed consent in accordance with federal, local, and institutional guidelines. 2. Age ≥ 18 years at the time of signing informed consent. 3. Patients must have previously received including proteasome inhibitors (PI) (i.e., lenalidomide) and immunomodulatory drugs (i.e., bortezomib) and were refractory to both drugs. 4. Any clinically significant non-hematological toxicities (except for peripheral neuropathy as described in exclusion criterion #17) that patients experienced from treatments in previous clinical studies must have resolved to Grade ≤ 2 by Cycle 1 Day 1. 5. Adequate hepatic function within 21 days prior to Cycle 1 Day 1: total bilirubin < 2x upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3x ULN), AST < 2.5x ULN and ALT < 2.5x ULN. 6. Adequate renal function within 21 days prior to Cycle 1 Day 1: estimated creatinine clearance of ≥ 20 mL/min, calculated using the formula of cockroft and gault. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. 8. Measurable MM based on IMWG guidelines. 9. Adequate hematopoietic function within 21 days prior to Cycle 1 Day 1 (See Exclusion Criterion #20 for transfusion washout periods for RBCs and platelets): 1. Hemoglobin level ≥ 8.5 g/dL. 2. ANC ≥ 1000/mm3. 3. Platelet count ≥ 75,000/mm3 (patients in whom < 50% of bone marrow nucleated cells are plasma cells) or ≥ 50,000/mm3 (patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells. [Platelet transfusions < 1 week prior to Cycle 1 Day 1 are prohibited (see below).] 10. Female subjects of child-bearing potential must have both of the following: 1. Agree to the use of two study physician-approved contraceptive methods simultaneously, or practice complete abstinence starting at the time of ICF signature, while on study medication, and 3 months following the last dose of study drug. 2. Have negative serum pregnancy test result at screening.

Exclusion Criteria:

  • - The presence of any of the following will exclude a subject from enrollment: 1.
Active smoldering MM. 2. Active plasma cell leukemia. 3. Documented systemic amyloid light chain amyloidosis. 4. Active central nervous system (CNS) MM. 5. Pregnancy or breastfeeding. 6. Chemotherapy ≤ 4 week, radiation and immunotherapy ≤ 4 weeks prior to Cycle 1 Day 1, and radio-immunotherapy 6 weeks prior to Cycle 1 Day 1. 7. Active graft vs. host disease (after allogeneic stem cell transplantation) at Cycle 1 Day 1. 8. Life expectancy of < 4 months. 9. Major surgery within four weeks prior to Cycle 1 Day 1. 10. Active, unstable cardiovascular function: 1. Symptomatic ischemia, or. 2. Uncontrolled clinically-significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics are excluded; patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or. 3. Congestive heart failure (CHF) of New York Heart Association (NYHA) Class ≥ 3, or. 4. Myocardial infarction (MI) within 3 months prior to Cycle 1 Day 1. 11. Prior exposure to a SINE compound, including ATG-010.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03944057
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Antengene Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ying Jiao, MD
Principal Investigator Affiliation Medical Monitor
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapse/Refractory Multiple Myeloma
Additional Details

This is a single-arm, open-label, multicenter study of ATG-010 (Selinexor) plus low dose Dexamethasone dosed twice weekly each week in four-week cycles, in patients with triple-refractory MM. The population refractory for the primary efficacy analysis will contain only patients with triple-MM enrolled. PK analysis would be performed which would contain approximately 30% of the patients enrolled. Safety analyses will be performed on the overall population of patients who received at least one dose of study drug among triple-refractory patient populations. Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard care, or withdrawal, whichever occurs first.

Arms & Interventions

Arms

Experimental: ATG-010 + Dexamethasone

Open-label ATG-010 80mg plus Dexamethasone 20 mg

Interventions

Drug: - ATG-010

ATG-010 (Selinexor) will be given at an oral fixed milligram (mg) dose of 80 mg twice weekly each week for four-week cycles (total of 8 ATG-010 doses per cycle). Dexamethasone 20 mg will be given with each dose of ATG-010 (Selinexor)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing, 100020

Site Contact

Wenming Chen, PhD

jasmine.sun@antengene.com

13701803117

Peking University Third Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, Beijing, 100191

Site Contact

Hongmei Jing, PhD

jasmine.sun@antengene.com

13701803117

Guangdong Provincial Peoples Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, 510000

Site Contact

Jianyu Wen, PhD

jasmine.sun@antengene.com

13701803117

Nanfang Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Nanfang Hospital

Guangzhou, Guangdong, 510515

Site Contact

Yongqiang Wei, PhD

jasmine.sun@antengene.com

13701803117

Sun Yat-Sen University Cancer Center, Guanzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-Sen University Cancer Center

Guanzhou, Guangdong, 510060

Site Contact

Zhongjun Xia, PhD

jasmine.sun@antengene.com

13701803117

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Henan Cancer Hospital

Zhengzhou, Henan, 450003

Site Contact

Baijun Fang, PhD

jasmine.sun@antengene.com

13701803117

Changsha, Hunan, China

Status

Not yet recruiting

Address

The Third Xiangya Hospital of Central Suoth University

Changsha, Hunan, 410013

Site Contact

Jing Liu, PhD

jasmine.sun@antengene.com

13701803117

Nanjing, Jiangsu, China

Status

Recruiting

Address

The First Affilate Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029

Site Contact

Lijuan Chen, PhD

jasmine.sun@antengene.com

13701803117

Suzhou, Jiangsu, China

Status

Recruiting

Address

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006

Site Contact

Zhengzheng Fu, PhD

jasmine.sun@antengene.com

13701803117

Nanchang, Jiangxi, China

Status

Recruiting

Address

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006

Site Contact

Fei Li, PhD

jasmine.sun@antengene.com

13701803117

Changchun, Jilin, China

Status

Recruiting

Address

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021

Site Contact

Sujun Gao, PhD

jasmine.sun@antengene.com

13701803117

Shenyang, Liaoning, China

Status

Recruiting

Address

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004

Site Contact

Zhuogang Liu, PhD

jasmine.sun@antengene.com

13701803117

Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Changzheng Hospital

Shanghai, Shanghai, 200003

Site Contact

Weijun Fu, PhD

jasmine.sun@antengene.com

13701803117

Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Sixth People's Hospital Affiliate Shanghai JiaoTong University

Shanghai, Shanghai, 200233

Site Contact

Chunkang Chang, PhD

jasmine.sun@antengene.com

13701803117

Xijing Hospital, Xi'an, Shanxi, China

Status

Recruiting

Address

Xijing Hospital

Xi'an, Shanxi, 710032

Site Contact

Xiequn Chen, PhD

jasmine.sun@antengene.com

13701803117

Tianjin blood research institute, Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin blood research institute

Tianjin, Tianjin, 300020

Site Contact

Lugui Qiu, MD

qiulg@ihcams.ac.cn

13701803117

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003

Site Contact

Zhen Cai, PhD

jasmine.sun@antengene.com

13701803117