APL-102 Capsule in Patients 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: NCT05055518|
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: APL-102 Capsules||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects will be assigned to a dose level of APL-102 in the order of study entry. A total of seven therapeutic dose levels (1mg, 2mg, 3mg, 5mg, 7mg, 9mg and 11mg) are planned. To reduce the number of subjects exposed to potentially ineffective doses and protect the rights and interests of subjects, rapid titration was used in the low-dose group (1 mg, 2 mg, 3 mg); When approaching the expected effective dose of 5 mg, the "3 + 3" study design was used.|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study on Safety, Tolerance, and Pharmacokinetics of APL-102 Capsule in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||August 2, 2021|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: A Phase I, open-labeled multicenter study
Drug: APL-102 Capsules
Dose escalation: A total of seven dose levels (1mg, 2mg, 3mg, 5mg, 7mg, 9mg and 11mg) are planned.
Dose extension: After RP2D determined, the RP2D dose level will be extended to enroll 6-10 subjects to further evaluated the safety and antitumor activity of APL-102.
Other Name: No other name so far
- DLT [ Time Frame: 36 days ]Dose limiting toxicities
- Adverse Events (AEs) [ Time Frame: From time of informed consent signature to 30 days after the subject's last visit (approximately 1 year) ]Adverse events occurred in all subjects during the study treatment according to the National Cancer Institute Common Terminology Standard for adverse events (NCI CTCAE) standard version 5.0
- Incidence of Adverse Events [ Time Frame: From time of informed consent signature to 30 days after the subject's last visit (approximately 1 year) ]The incidence of all adverse events with different severity (NCI CTCAE 5.0)
- Objective response rate(ORR) [ Time Frame: Approximately 1 year ]The objective response rate in patients of advanced solid tumors
- Duration of response(DOR) [ Time Frame: Approximately 1 year ]The duration of response in patients of advanced solid tumors
- Progression-free survival(PFS) [ Time Frame: Approximately 1 year ]The progression-free survival in patients of advanced solid tumors
- Overall survival(OS) [ Time Frame: Approximately 1 year ]The overall survival in patients of advanced solid tumors
- Peak plasma concentration (Cmax) [ Time Frame: 36 days ]To assess the pharmacokinetic profile in patients with advanced solid tumors.
- Time to reach Cmax (Tmax) [ Time Frame: 36 days ]To assess the pharmacokinetic profile in patients with advanced solid tumors.
- The area under the plasma concentration-time curve from time zero to the last measurable time point (AUC0-t) [ Time Frame: 36 days ]To assess the pharmacokinetic profile in patients with advanced solid tumors.
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): NCT05055518
|Contact: Zhejiang CrownMab Ltd.||0571-83521933||ClinicalTrialsChina@apollomicsinc.com|
|Contact: Qian Li||0571-83521933||Qian.Li@apollomicsinc.com|
|Cancer Institute and Hospital, Chinese Academy of Medical Sciences||Recruiting|
|Contact: Yihebali Chi, PhD 010-87788800 email@example.com|
|Principal Investigator:||Yihebali Chi, PhD||Investigator|