A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unres… (NCT04086758) | Clinical Trial Compass
CompletedPhase 1
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
China12 participantsStarted 2019-10-18
Plain-language summary
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects with Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has histologically confirmed diagnosis of gastric or gastro-esophageal junction (GEJ) adenocarcinoma, with radiologically confirmed locally advanced unresectable or metastatic disease, who has no standard of care treatment option or subject is ineligible to receive available standard of care treatment option (any line of treatment).
* Subject agrees not to use another investigational product or medical device while on treatment.
* A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:
* Not a woman of childbearing potential (WOCBP), OR
* WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
* Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
* Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
* A sexually active male subject with female partner(s) who are not of childbearing potential is eligible if:
* Agree to use a male condom starting at screening and continue throughou…
What they're measuring
1
Pharmacokinetics (PK) of zolbetuximab: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
Timeframe: Up to 15 months
2
PK of zolbetuximab: Percentage of AUCinf (AUCinf (%extrap))
Timeframe: Up to 15 months
3
PK of zolbetuximab: AUC from the time of dosing to the last measurable concentration (AUClast)
Timeframe: Up to 15 months
4
PK of zolbetuximab: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
Timeframe: Up to 15 months
5
PK of zolbetuximab: Maximum concertation (Cmax)
Timeframe: Up to 15 months
6
PK of zolbetuximab: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Timeframe: Up to 15 months
7
PK of zolbetuximab: Time of the maximum concentration (tmax)
Timeframe: Up to 15 months
8
PK of zolbetuximab: Terminal elimination half-life (t1/2)