Pumitamig and Combination Therapy Versus Bevacizumab and Combination Therapy in Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

The primary objective of the Phase 2 component is to compare the tumor response of participants receiving pumitamig in combination with chemotherapy against those receiving the standard of care. In the Phase 3 component, the primary objective is to evaluate tumor growth in participants treated with the study drug compared to the standard of care in patients with colorectal cancer. Secondary objectives include:

• Determination of the appropriate dose for the Phase 3 stage of the trial.
• Evaluation of the durability of response and overall survival in the Phase 3 stage.

The study population consists of 644 patients diagnosed with colorectal cancer that is untreated, unresectable, or metastatic. Participants include both males and females within specified age ranges. Selection is based on the presence of measurable disease via imaging. Inclusion requires that individuals have not previously received oncological treatment. Exclusion criteria involve the presence of dMMR/MSI-H status or a BRAF V600E mutation.

This Phase II/III, blinded, randomized clinical trial evaluates the efficacy and safety of pumitamig in combination with chemotherapy compared to bevacizumab combined with chemotherapy for the treatment of colorectal cancer that is untreated, unresectable, or metastatic. The Phase II component aims to compare the objective response rate between the study drug and the standard of care to assess effectiveness and establish appropriate dosing. The Phase III component focuses on comparing progression-free survival as the primary endpoint, while secondary endpoints include overall survival and duration of response. The study period is estimated to continue until March 2034.

Pumitamig is an experimental treatment administered as a concentrate for solution for infusion in strengths of 20 mg/ml or 50 mg/ml via intravenous infusion.

Oxaliplatin is administered as a solution for infusion at a dosage of 9999 mg/ml.

Calcium folinate is provided as a solution for injection at a dosage of 9999 mg/ml.

Fluorouracil is administered as a solution for injection at a dosage of 9999 mg/ml.

Capecitabine is administered for oral use at a dosage of 9999 mg.

Irinotecan hydrochloride trihydrate is administered as a solution for infusion at a dosage of 9999 mg/ml.

Bevacizumab is utilized as a comparator treatment, administered as a solution for infusion at a dosage of 9999 mg/ml.

Efficacy assessment in this Phase 2/3 study involves several distinct clinical endpoints. For the Phase 2 component, the primary objective is to compare the objective response rate between the study drug and the standard of care. Secondary objectives in this phase include the evaluation of the efficacy, safety, and tolerability of the investigational product to determine an appropriate dose.

In the Phase 3 component, the primary endpoint is progression-free survival, defined as the time from randomization to disease progression or death from any cause. Secondary endpoints include overall survival and duration of response, which measures the length of time the effects of the study drug on tumor growth persist following administration.