This study will assess the safety and anticancer activity of TQB2922 injection given under the skin together with chemotherapy in adults with colorectal cancer that has spread, cannot be removed by surgery, and has no RAS or BRAF mutations. Participants have not received systemic treatment for advanced colorectal cancer, apart from the prior adjuvant treatment allowed by the protocol. TQB2922 is designed to block two proteins involved in cancer growth. The study tests whether adding TQB2922 to chemotherapy can improve tumor response with tolerable side effects. An initial safety stage will help select doses for further study. In the next stage, participants will be randomly assigned in a 2:1 ratio to two TQB2922 dose groups, each receiving mFOLFOX6 chemotherapy (oxaliplatin, calcium folinate, and fluorouracil). The planned TQB2922 doses are 2000 mg and 1600 mg, subject to the initial safety findings. Participants and doctors will know the treatment given. After 6 to 8 treatment cycles, maintenance treatment consists of TQB2922 and fluorouracil, with protocol-specified exceptions. Each participant may remain in the study for up to 24 months.
Voluntary participation with written informed consent and good compliance.
Age 18 to 75 years, inclusive, at informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy greater than 12 weeks.
Known high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR).
Other malignancy within 3 years before the first dose or a concurrent malignancy. Protocol-permitted exceptions include other malignancies treated by surgery alone with 5 consecutive years of disease-free survival, and cured cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1).
Disease affecting intravenous administration or venous blood collection, or factors affecting oral medication, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
Toxicities from prior treatment not recovered to grade <=1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0. Exceptions include grade 2 alopecia, peripheral neurotoxicity, or anemia; asymptomatic laboratory abnormalities without clinical significance; stable hypothyroidism on hormone replacement; and other toxicities judged not to pose a safety risk.
Parallel
TQB2922 injection (subcutaneous administration)
DrugTQB2922 is an investigational bispecific antibody targeting epidermal growth factor receptor and c-Met. Administered subcutaneously at the assigned dose: weekly in cycle 1, then every 2 weeks in 28-day cycles. Phase Ib starts at 2000 mg with possible cohort dose reductions to 1600 mg and 1200 mg. Phase II planned doses are 2000 mg and 1600 mg, subject to phase Ib findings. Continued with fluorouracil during maintenance.
Oxaliplatin
DrugPlatinum-based antineoplastic component of mFOLFOX6. Oxaliplatin 85 mg/m\^2 by intravenous infusion every 2 weeks during the 6-to-8-cycle treatment phase. Used in all study arms; not listed in the protocol maintenance regimen.
Calcium folinate (leucovorin calcium)
DrugFolate component of mFOLFOX6. Calcium folinate 400 mg/m\^2 by intravenous infusion every 2 weeks during the 6-to-8-cycle treatment phase. Used in all study arms; not listed in protocol section 6.2.1 for maintenance.
Fluorouracil
DrugAntimetabolite component of mFOLFOX6. Fluorouracil 400 mg/m\^2 by intravenous bolus followed by 2400 mg/m\^2 by continuous intravenous infusion over 46 hours, repeated every 2 weeks. Used in all study arms during treatment and continued with TQB2922 in maintenance.
Recommended phase II dose (RP2D), phase Ib
Dose(s) of TQB2922 for combination with mFOLFOX6 selected jointly by the investigator and sponsor after assessment of safety, tolerability, pharmacokinetics, and preliminary activity in the phase Ib safety run-in.
Incidence and severity of adverse events, phase Ib
Percentage of participants with adverse events (AEs), with severity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0. Predose events are handled as specified in protocol section 8.4.1.
Incidence and severity of serious adverse events, phase Ib
Percentage of participants with serious adverse events (SAEs), with severity graded using NCI CTCAE version 6.0. Seriousness is assessed using the criteria in protocol section 8.4.5.
Incidence and severity of laboratory abnormalities, phase Ib
Percentage of participants with laboratory abnormalities and their severity, graded using NCI CTCAE version 6.0 where applicable. Laboratory assessments include hematology, biochemistry, coagulation, urinalysis, and thyroid function.
Peak concentration (Cmax), phase Ib
Maximum observed concentration of TQB2922. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t), phase Ib
Area under the TQB2922 concentration-time curve from time zero to the last quantifiable concentration. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
Time to peak concentration (Tmax), phase Ib
Time to the maximum observed TQB2922 concentration. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
Terminal elimination rate constant (lambda z), phase Ib
Terminal elimination rate constant estimated from the TQB2922 concentration-time profile. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
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