A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of a Study Drug in Subjects With Advanced Solid Tumors
|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: NCT04135261|
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: HBM4003||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HBM4003 in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||September 24, 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||February 2022|
Up to 4 (28 day) cycles of treatment with the potential for a higher dose to be administered in each of cycle 2 and cycle 4.
Intravenous (IV) administration on days 1, 8, 15 and 22 of a 28-day treatment cycle.
- Proportion of subjects with Dose-Limiting Toxicity (DLT) [ Time Frame: From Day 1 until disease progression or Day 28 ]Number of subjects who experience DLT events during 28 days after first administration of HBM4003, divided by the number of DLT-evaluable subjects
- Objective Response Rate [ Time Frame: Up to 28 months ]Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 and per Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST)
- Duration of response [ Time Frame: Up to 28 months ]Time interval from first occurrence of a documented objective response to the time of disease progression, as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first.
- Disease control rate [ Time Frame: Up to 28 months ]Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD).
- Duration of disease control [ Time Frame: Up to 28 months ]Time from data of start of treatment to the date of disease progression or death for subjects who had CR or PR or SD during treatment.
- Tumor shrinkage (The percentage of patients with tumor shrinkage) [ Time Frame: Up to 28 months ]Greatest tumor shrinkage achieved at any follow-up assessment. Measured by radiological (computed tomography [CT]/Magnetic Resonance Imaging [MRI]) scanning until documented radiographic disease progression according to RECIST 1.1, or loss of clinical benefit after disease progression according to RECIST 1.1
- Cmax (Maximum serum concentration) [ Time Frame: Up to 28 months ]
- Tmax (Time to reach maximum serum concentration) [ Time Frame: Up to 28 months ]Plasma
- AUC0-tau (Area under the serum concentration versus time curve from time zero to the dosing interval tau [ Time Frame: Up to 28 months ]
- AUC0-inf (Area under the serum concentration versus time curve from time zero to infinity [ Time Frame: Up to 28 months ]
- t1/2 (Terminal half-life) [ Time Frame: Up to 28 months ]
- Clearance (CL) [ Time Frame: Up to 28 months ]
- Vss (Volume of distribution at steady state) [ Time Frame: Up to 28 months ]
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): NCT04135261
|Contact: Maria||+86 email@example.com|
|Contact: Alma||+86 firstname.lastname@example.org|
|Australia, New South Wales|
|St. George Private Hospital, 1 South Street||Recruiting|
|Kogarah, New South Wales, Australia, 2217|
|Contact: Amanda Idan +61 02 8594 5785 IdanA@ramsayhealth.com.au|
|Macquarie University, 2 Technology Place||Not yet recruiting|
|Macquarie, New South Wales, Australia, 2109|
|Monash Health, Monash Medical Centre, 246 Clayton Road||Recruiting|
|Clayton, Victoria, Australia, 3168|
|Contact: Penny Macquire +61 03 8572 2429 Penelope.Macquire@monashhealth.org|
|The Alfred Hospital, Commercial Road||Not yet recruiting|
|Melbourne, Victoria, Australia, 3004|