Colorectal NeoplasmsPhase 1/2NCT07844187
TQB2922 Injection Given Under the Skin With Chemotherapy as Initial Treatment for Colorectal Cancer That Has Spread
A Phase 1/2 study testing TQB2922 injection (subcutaneous administration), Oxaliplatin and Calcium folinate (leucovorin calcium) in people with Colorectal Neoplasms, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- TQB2922 injection (subcutaneous administration), Oxaliplatin and Calcium folinate (leucovorin calcium)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 16 sitesChina
- Study dates
- 20 Oct 2026to 31 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
- Use of immunosuppressants or systemic or absorbable topical steroids for immunosuppression, with continued use required within 7 days before the first dose; except prednisone <10 mg/day or an equivalent glucocorticoid dose.
- Epilepsy requiring treatment.
- Any of the following cancer-related conditions or treatments: chemotherapy/immunotherapy within 3 weeks, radiotherapy/small-molecule targeted therapy within 2 weeks, or treatment within 5 drug half-lives before the first dose (the shortest interval, as stated in the protocol); Chinese patent medicines with a National Medical Products Administration (NMPA)-approved anticancer indication within 2 weeks before the first dose; uncontrolled, symptomatic, or repeatedly drained pleural, peritoneal, or pericardial effusions (small, asymptomatic imaging-only effusions without drainage or treatment in the preceding 2 weeks are allowed); known central nervous system metastases and/or carcinomatous meningitis (except asymptomatic cases, or treated stable cases without imaging evidence of new/enlarging brain metastases for at least 2 weeks after brain-metastasis treatment and off steroids/anticonvulsants for at least 14 days before study treatment); or severe bone damage/spinal cord compression from bone metastases, including weight-bearing pathological fractures within 6 months or anticipated soon, or poorly controlled severe bone pain.
- Known allergy to excipients of the study drug.
- Prior antiangiogenic or anti-epidermal growth factor receptor (EGFR) targeted treatment, including bevacizumab, cetuximab, panitumumab, or aflibercept.
- Prior systemic treatment for advanced colorectal cancer. Adjuvant treatment is permitted if completed >12 months before study start for oxaliplatin-containing chemotherapy, or >6 months for chemotherapy without oxaliplatin, measured from the last chemotherapy dose.
- Receipt of another investigational anticancer drug within 4 weeks before the first dose.
- Any other condition that, in the investigator's judgment, seriously compromises safety or the ability to complete the study.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites
People's Liberation Army General Hospital of China
Beijing, Beijing Municipality, 100853
Yanyun Zhu, Master, 18910621887, Zhuyanyunmm@163.com
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
heli liu, doctor, 13874967285, heliliu@csu.edu.cn
xingui xiong, doctor, 13787251637, xxg_xyz@126.com
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yi He, Doctor, 18692237222, heyi@hnca.org.cn
The First People'S Hospital of Foshan
Foshan, Guangdong, 528000
Wei Wang, Doctor, 18038863618, wangwei@fsyyy.com
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
zhiwei Li, postdoctoral, 15004683651, lzhw0451@163.com
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000
Dong Yan, Master's Degree, 13659438336, 752201300@qq.com
Lishui Central Hospital
Lishui, Zhejiang, 323000
Yanru Xie, Master's degree, 13567615770, 43437677@qq.com
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Nanjing, Jiangsu, 210029
Yanhong Gu, Doctor of Medicine, +86 13813908678, guyanhong@jsph.org.cn
Guangxi Cancer Hospital, Affiliated to Guangxi Medical University
Nanning, Guangxi, 530200
YUMEI ZHANG, Master, 13617716921, Zhzm05@163.com
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, Doctor, 13681973996, liu.tianshu@zs-hospital.sh.cn
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
XiuYing Xiao, Doctor, 13564579313, xiaoxiuying2002@163.com
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
zhiyu Chen, MD, 13818197511, chanhj75@aliyun.com
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Ting Deng, Doctor, 15802243063, xymcdengting@126.com
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Hongli Liu, Doctor, 13995680822, whliuhongli@163.com
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Ping Sun, Doctor, 13963896536, Sunping20039@hotmail.com
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008
ying liu, Doctor, 13783604602, yaya7207@126.com
About this study
Official title: 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
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- TQB2922 injection (subcutaneous administration), Oxaliplatin, Calcium folinate (leucovorin calcium), Fluorouracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2922 injection (subcutaneous administration)Drug
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.
OxaliplatinDrug
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.
Calcium folinate (leucovorin calcium)Drug
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.
FluorouracilDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib safety run-in: TQB2922 injection + mFOLFOX6 | Experimental | Nonrandomized 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. Receives: Drug: TQB2922 injection (subcutaneous administration); Drug: Oxaliplatin; Drug: Calcium folinate (leucovorin calcium); Drug: Fluorouracil |
| Phase II 2000 mg group: TQB2922 injection + mFOLFOX6 | Experimental | Participants 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. Receives: Drug: TQB2922 injection (subcutaneous administration); Drug: Oxaliplatin; Drug: Calcium folinate (leucovorin calcium); Drug: Fluorouracil |
| Phase II 1600 mg group: TQB2922 injection + mFOLFOX6 | Experimental | Participants 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. Receives: Drug: TQB2922 injection (subcutaneous administration); Drug: Oxaliplatin; Drug: Calcium folinate (leucovorin calcium); Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Maximum observed concentration of TQB2922. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Time required for the TQB2922 concentration to decrease by half in the terminal elimination phase. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
Measured: 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).
Apparent clearance (CL/F), phase Ib
Apparent clearance of TQB2922 following subcutaneous administration. F denotes bioavailability. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
Measured: 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).
Apparent terminal volume of distribution (Vz/F), phase Ib
Apparent volume of distribution of TQB2922 during the terminal phase following subcutaneous administration. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
Measured: 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).
Extrapolated percentage of AUC0-infinity (%AUCextrap), phase Ib
Percentage of the total TQB2922 AUC extrapolated from the last quantifiable concentration to infinity. Estimated by noncompartmental analysis in participants undergoing intensive pharmacokinetic (PK) sampling. C denotes cycle and D denotes day.
Measured: 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).
Objective response rate (ORR), phase Ib
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.
Measured: 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 Ib
Percentage of participants with a best overall response of CR, PR, or stable disease (SD), assessed by the investigator using RECIST version 1.1.
Measured: 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 Ib
Time from first dose to investigator-assessed disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: 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 Ib
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.
Measured: From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
Incidence of anti-drug antibodies (ADA), phase Ib
Percentage of participants with anti-TQB2922 antibodies detected by a validated assay. ADA-positive samples undergo neutralizing-antibody testing. C denotes cycle and D denotes day.
Measured: Within 2 hours before dosing on Day 1 of Cycles 1, 2, 4 and 8; at end of treatment; and 90 days (+/-7 days) after the last dose. Additional samples for protocol-specified reactions.
Incidence and severity of adverse events, phase II
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.
Measured: 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 II
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.
Measured: 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 II
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844187
- Sponsor's protocol ID
- TQB2922-Ib/II-02
- Status last verified
- Jun 2026
- First submitted
- 16 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07844187
- Acronym / sponsor ID
- TQB2922-Ib/II-02
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ib safety run-in: TQB2922 injection + mFOLFOX6 | Experimental | Drug: TQB2922 injection (subcutaneous administration), Drug: Oxaliplatin, Drug: Calcium folinate (leucovorin calcium), Drug: FluorouracilNonrandomized 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 | Experimental | Drug: TQB2922 injection (subcutaneous administration), Drug: Oxaliplatin, Drug: Calcium folinate (leucovorin calcium), Drug: FluorouracilParticipants 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 | Experimental | Drug: TQB2922 injection (subcutaneous administration), Drug: Oxaliplatin, Drug: Calcium folinate (leucovorin calcium), Drug: FluorouracilParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2922 injection (subcutaneous administration)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. | Drug | Phase II 1600 mg group: TQB2922 injection + mFOLFOX6, Phase II 2000 mg group: TQB2922 injection + mFOLFOX6, Phase Ib safety run-in: TQB2922 injection + mFOLFOX6 |
| OxaliplatinPlatinum-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. | Drug | Phase II 1600 mg group: TQB2922 injection + mFOLFOX6, Phase II 2000 mg group: TQB2922 injection + mFOLFOX6, Phase Ib safety run-in: TQB2922 injection + mFOLFOX6 |
| Calcium folinate (leucovorin calcium)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. | Drug | Phase II 1600 mg group: TQB2922 injection + mFOLFOX6, Phase II 2000 mg group: TQB2922 injection + mFOLFOX6, Phase Ib safety run-in: TQB2922 injection + mFOLFOX6 |
| FluorouracilAntimetabolite 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. | Drug | Phase II 1600 mg group: TQB2922 injection + mFOLFOX6, Phase II 2000 mg group: TQB2922 injection + mFOLFOX6, Phase Ib safety run-in: TQB2922 injection + mFOLFOX6 |
Primary outcome
Recommended phase II dose (RP2D), phase Ib
Time frame: During the Phase Ib safety run-in period, approximately 28 days.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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.
Objective response rate (ORR), phase II
Time frame: From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
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.
Disease control rate (DCR), phase II
Time frame: From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
Percentage of participants with a best overall response of CR, PR, or stable disease (SD), assessed by the investigator using RECIST version 1.1.
Progression-free survival (PFS), phase II
Time frame: From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
Time from randomization to investigator-assessed disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Duration of response (DOR), phase II
Time frame: From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
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.
16 secondary outcomes
Peak concentration (Cmax), phase Ib
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Apparent clearance (CL/F), phase Ib
Time frame: 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).
Apparent terminal volume of distribution (Vz/F), phase Ib
Time frame: 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).
Extrapolated percentage of AUC0-infinity (%AUCextrap), phase Ib
Time frame: 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).
Objective response rate (ORR), phase Ib
Time frame: 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 Ib
Time frame: 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 Ib
Time frame: 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 Ib
Time frame: From baseline, every 6 weeks (+/-7 days) through week 48 and every 12 weeks (+/-7 days) thereafter; up to 24 months.
Incidence of anti-drug antibodies (ADA), phase Ib
Time frame: Within 2 hours before dosing on Day 1 of Cycles 1, 2, 4 and 8; at end of treatment; and 90 days (+/-7 days) after the last dose. Additional samples for protocol-specified reactions.
Incidence and severity of adverse events, phase II
Time frame: 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 II
Time frame: 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 II
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB2922 injection (subcutaneous administration), Oxaliplatin and Calcium folinate (leucovorin calcium) in people with Colorectal Neoplasms, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Gu, Doctor of Medicine (+86 13813908678, guyanhong@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended phase II dose (RP2D), phase Ib (time frame: During the Phase Ib safety run-in period, approximately 28 days.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.