TQB2922 Injection Given Under the Skin With Chemotherapy as Initial Treatment for Colorectal Cancer That Has Spread
A Phase Ib/II Clinical Trial of TQB2922 Injection (Subcutaneous Administration) Combined With Chemotherapy as First-Line Treatment for RAS/BRAF Wild-Type Unresectable Metastatic Colorectal Cancer
1 other identifier
interventional
64
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2026
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2026
CompletedFirst Posted
Study publicly available on registry
September 28, 2026
CompletedStudy Start
First participant enrolled
October 20, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
Study Completion
Last participant's last visit for all outcomes
March 31, 2028
September 28, 2026
June 1, 2026
11 months
September 16, 2026
September 21, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
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.
During the Phase Ib safety run-in period, approximately 28 days.
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.
From informed consent to 30 days after the last dose or start of new anticancer therapy, whichever occurs first; study participation up to 24 months.
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.
From informed consent to 30 days after the last dose or start of new anticancer therapy, whichever occurs first; study participation up to 24 months.
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.
From informed consent to 30 days after the last dose or start of new anticancer therapy, whichever occurs first; study participation up to 24 months.
Objective response rate (ORR), phase II
Percentage of participants with a best overall response of complete response (CR) or partial response (PR), assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
Disease control rate (DCR), phase II
Percentage of participants with a best overall response of CR, PR, or stable disease (SD), assessed by the investigator using RECIST version 1.1.
From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
Progression-free survival (PFS), phase II
Time from randomization to investigator-assessed disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
Duration of response (DOR), phase II
Among responders, time from the first documented CR or PR to investigator-assessed disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
Secondary Outcomes (16)
Peak concentration (Cmax), phase Ib
Within 2 hours before dosing on specified days of Cycles 1, 2, 4 and 8; through 72 hours after dosing on Day 1 of Cycle 1 and through 168 hours after dosing on Day 1 of Cycle 4 (28-day cycles; sampling windows specified in the description).
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t), phase Ib
Within 2 hours before dosing on specified days of Cycles 1, 2, 4 and 8; through 72 hours after dosing on Day 1 of Cycle 1 and through 168 hours after dosing on Day 1 of Cycle 4 (28-day cycles; sampling windows specified in the description).
Time to peak concentration (Tmax), phase Ib
Within 2 hours before dosing on specified days of Cycles 1, 2, 4 and 8; through 72 hours after dosing on Day 1 of Cycle 1 and through 168 hours after dosing on Day 1 of Cycle 4 (28-day cycles; sampling windows specified in the description).
Terminal elimination rate constant (lambda z), phase Ib
Within 2 hours before dosing on specified days of Cycles 1, 2, 4 and 8; through 72 hours after dosing on Day 1 of Cycle 1 and through 168 hours after dosing on Day 1 of Cycle 4 (28-day cycles; sampling windows specified in the description).
Elimination half-life (t1/2), phase Ib
Within 2 hours before dosing on specified days of Cycles 1, 2, 4 and 8; through 72 hours after dosing on Day 1 of Cycle 1 and through 168 hours after dosing on Day 1 of Cycle 4 (28-day cycles; sampling windows specified in the description).
- +11 more secondary outcomes
Study Arms (3)
Phase Ib safety run-in: TQB2922 injection + mFOLFOX6
EXPERIMENTALNonrandomized safety run-in. TQB2922 starts at 2000 mg; separate 1600 mg and 1200 mg cohorts may be enrolled sequentially if dose reduction is needed for intolerance. TQB2922 is given subcutaneously on days 1, 8, 15, and 22 of cycle 1 and on days 1 and 15 of later 28-day cycles, with oxaliplatin, calcium folinate, and fluorouracil (mFOLFOX6) every 2 weeks. After 6 to 8 cycles, maintenance comprises TQB2922 plus fluorouracil, subject to protocol-permitted exceptions and stopping rules.
Phase II 2000 mg group: TQB2922 injection + mFOLFOX6
EXPERIMENTALParticipants in phase II are randomized 2:1 to the 2000 mg and 1600 mg groups. This group receives TQB2922 2000 mg; final dose selection depends on phase Ib safety and tolerability. TQB2922 is given subcutaneously on days 1, 8, 15, and 22 of cycle 1 and on days 1 and 15 of later 28-day cycles, with oxaliplatin, calcium folinate, and fluorouracil (mFOLFOX6) every 2 weeks. After 6 to 8 cycles, maintenance comprises TQB2922 plus fluorouracil, subject to protocol-permitted exceptions and stopping rules.
Phase II 1600 mg group: TQB2922 injection + mFOLFOX6
EXPERIMENTALParticipants in phase II are randomized 2:1 to the 2000 mg and 1600 mg groups. This group receives TQB2922 1600 mg; final dose selection depends on phase Ib safety and tolerability. TQB2922 is given subcutaneously on days 1, 8, 15, and 22 of cycle 1 and on days 1 and 15 of later 28-day cycles, with oxaliplatin, calcium folinate, and fluorouracil (mFOLFOX6) every 2 weeks. After 6 to 8 cycles, maintenance comprises TQB2922 plus fluorouracil, subject to protocol-permitted exceptions and stopping rules.
Interventions
Platinum-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.
Folate 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.
Antimetabolite 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.
TQB2922 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.
Eligibility Criteria
You may qualify if:
- 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.
- Histologically or cytologically confirmed unresectable metastatic colorectal cancer, staged according to the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) TNM classification, 8th edition (2017).
- RAS/BRAF wild-type status confirmed in tumor tissue.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate laboratory results: hemoglobin \>=90 g/L; absolute neutrophil count \>=1.5 x 10\^9/L; platelets \>=100 x 10\^9/L; total bilirubin \<=1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase \<=2.5 x ULN, or \<=5 x ULN with liver metastases; creatinine clearance \>=60 mL/min calculated using the modified Cockcroft-Gault formula; urine protein \<=1+, or, if \>=2+, 24-hour urine protein \<1 g measured within 7 days; prothrombin time, activated partial thromboplastin time, and international normalized ratio \<=1.5 x ULN in participants not receiving anticoagulation; thyroid-stimulating hormone \<=ULN, or, if abnormal, normal triiodothyronine and thyroxine (or their free fractions).
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment. Participants of reproductive potential must agree to effective contraception during the study and for 6 months after study completion, following protocol section 5.4.4
You may not qualify if:
- 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.
- Major surgery or significant traumatic injury within 4 weeks before the first dose, expected major surgery during the study (except protocol-permitted surgery), or a persistently unhealed wound or fracture.
- Poorly controlled active viral hepatitis. Hepatitis B surface antigen-positive participants may be screened if hepatitis B virus (HBV) DNA is \<2000 IU/mL (or 1 x 10\^4 copies/mL), or if at least 1 week of anti-HBV treatment before study start has reduced viral load at least 10-fold, and they agree to anti-HBV treatment throughout the study. Participants positive for hepatitis C virus (HCV) antibody or HCV RNA may be screened if judged stable by the investigator, or if receiving antiviral treatment at enrollment and continuing approved antiviral treatment during the study.
- History of noninfectious pneumonitis/interstitial lung disease requiring steroids, or current noninfectious pneumonitis/interstitial lung disease; or hospitalization or therapeutic antibiotics for active infection within 4 weeks before study treatment, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- History of psychiatric drug abuse that cannot be discontinued, or a psychiatric disorder.
- Planned or previous allogeneic bone marrow transplantation or solid organ transplantation.
- History of hepatic encephalopathy.
- Significant cardiovascular disease, including any of the following: New York Heart Association (NYHA) class II or higher cardiac dysfunction or left ventricular ejection fraction \<50%; clinically significant ventricular arrhythmia or arrhythmia requiring continuous antiarrhythmic therapy; unstable angina; myocardial infarction within 12 months; Fridericia-corrected QT interval \>450 ms in men or \>470 ms in women (an abnormal value may be assessed by the mean of 3 measurements at least 2 minutes apart); personal or family history of congenital long QT syndrome; arterial or venous thrombosis within 6 months before the first dose; systolic blood pressure \>=150 mmHg and/or diastolic blood pressure \>=90 mmHg despite standard treatment, or prior hypertensive encephalopathy/crisis; clinically significant tumor bleeding/perforation or grade \>=3 bleeding within 1 month before treatment; bleeding/coagulation disease while receiving warfarin, aspirin, or other antiplatelet agents (except maintenance aspirin \<=100 mg/day or clopidogrel \<=75 mg/day); or other bleeding signs/history judged unsuitable by the investigator.
- Poorly controlled diabetes with fasting blood glucose \>10 mmol/L.
- Active or uncontrolled serious infection of CTCAE grade \>=2.
- Renal failure requiring hemodialysis or peritoneal dialysis.
- History of immunodeficiency, including human immunodeficiency virus (HIV) positivity or another acquired or congenital immunodeficiency.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
People's Liberation Army General Hospital of China
Beijing, Beijing Municipality, 100853, China
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000, China
The First People'S Hospital of Foshan
Foshan, Guangdong, 528000, China
Guangxi Cancer Hospital, Affiliated to Guangxi Medical University
Nanning, Guangxi, 530200, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Nanjing, Jiangsu, 210029, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000, China
Lishui Central Hospital
Lishui, Zhejiang, 323000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2026
First Posted
September 28, 2026
Study Start (Estimated)
October 20, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
September 28, 2026
Record last verified: 2026-06