CA102N Combined With TAS-102 Compared to Bevacizumab Combined With TAS-102 in Subjects With Metastatic Colorectal Cancer

Phase 2 Suspended 100 enrolled Holy Stone Healthcare Co., Ltd

RandomizedParallel-groupOpen-labelTreatment

Summary

HS-CA102N-103 is a Phase 2, randomized, open label study to evaluate efficacy, safety, and tolerability of CA102N combined with trifluridine/tipiracil (TAS-102) compared to bevacizumab combined with TAS-102 in subjects with metastatic colorectal cancer (mCRC) who failed the standard treatment (for eg, cancer that has relapsed after or is refractory to fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy).

Timeline

Start: 2027-12
Primary completion: 2030-10
Completion: 2031-09

Outcome

Outcome not reported

Stopped (Business): “Strategy under discussion”

Publications

Results Pant S, Dragovich T, Lieu C, Jimeno A, Kundranda M, Menter D, Tchaparian E, Chen YC, Kopetz S. Phase 1 study of the safety, pharmacokinetics, and preliminary efficacy of CA102N as monotherapy and in combination with trifluridine-tipiracil in patients with locally advanced or metastatic solid tumors. Invest New Drugs. 2023 Feb;41(1):25-34. doi: 10.1007/s10637-022-01308-5. Epub 2022 Nov 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	CA102N	Other / unclassified	0.72 mg/kg	Intravenous
Background	Tipiracil	Small molecule	—	Oral
Background	Trifluridine	Small molecule	—	Oral