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TAS 102

Phase 2

Gastroesophageal Junction Adenocarcinoma | Small molecule | Oncology |Avalon GloboCare Corp.|Last Updated: Jun 14, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

TAS 102 · 1 trial · 2 indications

Phase 2 1
NCT04808791iTTo for Treatment Naive Advanced Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaGastroesophageal Junction Adenocarcinoma
COMPLETED7 Analytics
PHASE2COMPLETED
iTTo for Treatment Naive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Gastroesophageal Junction AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

The number of participants who complete at least 2 cycles of iTTo for the treatment of advanced gastric and GEJ cancers, over the total duration of study
1 year after enrolment of last participant.

The number of participants who complete at least 2 cycles of iTTo for the treatment of advanced gastric and GEJ cancers, over the total duration of study.

Safety/Tolerability
Through study completion, up to 2 years.

Treatment related and non-related adverse events per CTCAE v.5.0 of iTTo for the treatment of advanced gastric and GEJ cancers. Incidence of adverse events, the number of dose modifications and discontinuations due to adverse events.

Secondary Endpoints

Objective Response Rate
1 year after enrollment of last participant.
Progression Free Survival
5 years from final study drug dose.
Overall Survival
5 years from final study drug dose.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Arm iTTO treatmentEXPERIMENTALPatients will receive the combination of irinotecan, TAS-102, and Oxaliplatin on a 28 day cycle with the following doses; * Irinotecan 160mg/m2 IV infusion over 60-90 mins on day 1 * Oxaliplatin 100mg/m2 IV infusion over 2 hours on day 1 * TAS-102 (Trifluridine/Tipiracil) 25mg/m2 twice a day, on days 1-5 and 8-12 every 28days.

Interventions

NameTypeDescription
IrinotecanDRUGIrinotecan is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase I inhibitor."
OxaliplatinDRUGOxaliplatin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Oxaliplatin is classified as an "alkylating agent."
TAS 102 (Trifluridine/Tipiracil)DRUGTrifluridine/Tipiracil is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as an antimetabolite/pyrimidine analog; antimetabolite/thymidine phosphorylase inhibitor
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients must be 18 years of age or older. 2. Histologically documented locally advanced or metastatic gastric or GEJ adenocarcinoma not previously treated with palliative systemic therapy. 3. Patients must be capable of providing consent to enrolment and treatment. 4. Patien...

Countries:Canada
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Frequently asked questions about TAS 102

What is TAS 102 used for?

TAS 102 is an investigational small molecule being studied for the treatment of gastroesophageal junction adenocarcinoma and advanced gastric carcinoma. It is currently in Phase 2 clinical development for these oncology indications.

Who is developing TAS 102?

TAS 102 is being developed by Avalon GloboCare Corp., a biopharmaceutical company traded on the stock exchange under the ticker symbol ALBT.

What phase is TAS 102 in?

TAS 102 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for any use.

What clinical trials is TAS 102 in?

TAS 102 has one completed Phase 2 clinical trial, identified as NCT04808791, titled "iTTo for Treatment Naive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma." The trial enrolled 7 participants in Canada.

Is TAS 102 being studied in a randomized trial?

No, the completed Phase 2 trial of TAS 102 was not randomized and did not use a control group. It was an uncontrolled study that enrolled 7 patients with gastroesophageal junction adenocarcinoma or advanced gastric carcinoma.