A Phase 1b/2 study of arfolitixorin combined with 5-fluorouracil, oxaliplatin, and bevacizumab in first-line treatment of metastatic colorectal cancer

Conditions

metastatic colorectal cancer

Brief summary

Phase 1b and Phase 2: Number and severity of AEs, including clinically significant abnormal laboratory findings, regardless of causal relationship to ARFOX + bevacizumab. The outcome of Phase 1b is to determine the MTD of arfolitixorin (ARFOX + bevacizumab) in patients with mCRC., Phase 2: ORR, defined as the proportion of patients who have BOR of CR, or PR, measured from the start of the study treatment until the EOT by RECIST (version 1.1).

Detailed description

Phase 1b: ORR, defined as the proportion of patients who have BOR of CR, or PR, measured from the start of the study treatment until the EOT by RECIST (version 1.1)., Phase 1b and Phase 2: PFS, defined as the time from the first study dose date to the date of first documentation of confirmed disease progression or death (whichever occurs first)., Phase 1b and Phase 2: OS, measured from the date of study treatment initiation to the date of death., Phase 1b: Plasma concentration of arfolitixorin.

Sebastian Stintzing, Arndt Stahler, Annabel Alig, Isabel Löwstedt, Marcus Thuresson et al. (6 authors)

Cancer Research2026-04-17

10.1158/1538-7445.am2026-ct218

Phase 1b/2 study of arfolitixorin in combination with 5-fluorouracil (5FU), oxaliplatin, and bevacizumab as first-line therapy for metastatic colorectal cancer (mCRC).

Sebastian Stintzing, Arndt Stahler, Isabel Löwstedt, Marcus Thuresson, Roger Tell

Journal of Clinical Oncology2026-01-10

10.1200/jco.2026.44.2_suppl.tps254

Interventions

DRUGArfolitixorin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1b and Phase 2: Number and severity of AEs, including clinically significant abnormal laboratory findings, regardless of causal relationship to ARFOX + bevacizumab. The outcome of Phase 1b is to determine the MTD of arfolitixorin (ARFOX + bevacizumab) in patients with mCRC., Phase 2: ORR, defined as the proportion of patients who have BOR of CR, or PR, measured from the start of the study treatment until the EOT by RECIST (version 1.1).	—

Measure

Time frame

Phase 1b and Phase 2: Number and severity of AEs, including clinically significant abnormal laboratory findings, regardless of causal relationship to ARFOX + bevacizumab. The outcome of Phase 1b is to determine the MTD of arfolitixorin (ARFOX + bevacizumab) in patients with mCRC., Phase 2: ORR, defined as the proportion of patients who have BOR of CR, or PR, measured from the start of the study treatment until the EOT by RECIST (version 1.1).

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Secondary

Measure	Time frame
Phase 1b: ORR, defined as the proportion of patients who have BOR of CR, or PR, measured from the start of the study treatment until the EOT by RECIST (version 1.1)., Phase 1b and Phase 2: PFS, defined as the time from the first study dose date to the date of first documentation of confirmed disease progression or death (whichever occurs first)., Phase 1b and Phase 2: OS, measured from the date of study treatment initiation to the date of death., Phase 1b: Plasma concentration of arfolitixorin.	—