Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04900818|
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : June 22, 2023
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Advanced Cancer Metastatic Cancer Gastric Cancer Gastroesophageal Junction Carcinoma Esophageal Adenocarcinoma||Drug: TJ033721||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors|
|Actual Study Start Date :||June 29, 2021|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: Dose Escalation: TJ033721
Dose Escalation:: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi-weekly (Q2W)
During dose expansion, TJ033721 will be administered Q2W, starting at the highest dose to have cleared the DLT period.
After the conclusion of dose expansion TJ033721 will be administered Q2W at the MAD or RP2D.
Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
- Dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]
- Incidence and severity of AEs [ Time Frame: Up to 100 days post last dose ]The CTCAE criteria will be used to assess adverse events on this trial.
- Maximum tolerated or administered dose (MTD, MAD) [ Time Frame: 28 Days ]Based on DLT definitions
- Pharmacokinetic (PK) Parameters: AUC∞ [ Time Frame: Up to 100 days post last dose ]Area under the curve from time zero extrapolated to infinity (AUC∞)
- Pharmacokinetic (PK) Parameters: AUCt [ Time Frame: up to 100 days post last dose ]AUC from time zero to the time of the last quantifiable concentration (AUC0-t)
- Pharmacokinetic (PK) Parameters: Cmax [ Time Frame: up to 100 days post last dose ]Maximum observed concentration
- Pharmacokinetic Parameters: Tmax [ Time Frame: up to 100 days post last dose ]Time of peak concentration (Tmax)
- Pharmacokinetic Parameters: T1/2 [ Time Frame: up to 100 days post last dose ]Investigational Product (IP) half-life (T1/2)
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): NCT04900818
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