RAS/BRAF Wild Type Colorectal CancerPhase 1/2NCT07044908
TQB2922 and TAS-102 Tablets for Injection With or Without Bevacizumab in Chemotherapy-failed RAS/BRAF Wild-type Advanced Colorectal Cancer
A Phase 1/2 study testing TQB2922 injection ± TAS-102 tablets and TQB2922 injection+TAS-102 tablets ± Bevacizumab in people with RAS/BRAF Wild Type Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 27 sites in China.
Trial summary
This is a multicenter, open Phase Ib/II clinical study evaluating the safety and efficacy of TQB2922 in combination with TAS-102±bevacizumab in subjects with RAS/BRAF wild-type unresectable locally advanced or metastatic colorectal cancer that has failed treatment with oxaliplatin, fluorouracil-based and irinotecan. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- RAS/BRAF Wild Type Colorectal Cancer
- What is being tested?
- TQB2922 injection ± TAS-102 tablets and TQB2922 injection+TAS-102 tablets ± Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 27 sitesChina
- Study dates
- 30 Jul 2025to Jul 2027
- 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
- Subjects voluntarily enrolled in the study, signed the informed consent and had good compliance;
- Age: 18-75 years old (including boundaries at the time of signing the informed consent);
- Eastern Cooperative Oncology Group (ECOG) score: 0-1;
- Expected survival of more than 3 months;
- Unresectable locally advanced or metastatic colorectal cancer diagnosed by histological/cytological pathology;
- Disease progression or intolerable after prior treatment with oxaliplatin, fluorouracil-based and irinotecan and treated with cetuximab or bevacizumab;
Show all 11Show fewer
- Patients with genetic testing showing wild-type for both rat sarcoma (RAS) and B-type rapid response protein kinase (BRAF);
- Presence of at least 1 measurable lesion according to RECIST 1.1 criteria;
- Laboratory tests meet the criteria;
- Female subjects of childbearing potential must agree to use contraception (e.g., Intrauterine Device (IUD), birth control pills, or condoms) for the duration of the study and for 6 months after the end of the study; must have a negative serum pregnancy/urine pregnancy test
- within 7 days prior to study entry and must not be breastfeeding; male subjects must agree to use contraception for the duration of the study and for 6 months after the end of the study.
Who cannot join
- Patients who have had previous confirmation of microsatellite high instability/mismatch repair defects (MSI-H/dMMR) by immunohistochemistry (IHC), next-generation sequencing (NGS) or polymerase chain reaction (PCR);
- Presence of a disease that interferes with intravenous administration, intravenous blood collection, or multiple factors that interfere with oral administration of medications (e.g., inability to swallow, chronic diarrhoea and intestinal obstruction);
- Active inflammatory bowel disease (ulcerative colitis, Crohn's disease) within 28 days prior to first dose;
- The presence or current concurrent presence of other malignancies within 2 years prior to the first dose.
- Unresolved toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to any prior therapy, excluding alopecia, fatigue and peripheral neuropathy;
- Major surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to first dose;
Show all 28Show fewer
- The presence of a long-standing unhealed wound or fracture;
- Cerebrovascular accident (including temporary ischaemic attack, cerebral haemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 6 months prior to the first dose;
- Have a history of psychotropic substance abuse and are unable to quit or have a mental disorder;
- Subjects with any severe and/or uncontrolled medical condition, including:
- Unsatisfactory control of blood pressure (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, at least 2 measurements taken at intervals of more than 24h);
- Myocardial infarction, unstable angina pectoris, stable angina pectoris ≥ Grade 2, heart failure ≥ Grade 2 (New York Heart Association (NYHA) classification), arrhythmia ≥ Grade 2;
- Active or uncontrolled severe bacterial, viral, or systemic fungal infection (≥ CTC AE grade 2 infection) within 28 days prior to first dose; patients with active tuberculosis within 1 year prior to enrolment.
- Active viral hepatitis with poor control. Subjects will be screened if they meet the following requirements: Hepatitis B surface antigen (HBsAg) positive subjects with Hepatitis B virus (HBV) DNA quantification <2000 IU/ml (or 1*10 4 copy/ml) or at least 1 week of anti-HBV treatment with a 10-fold (1 log) or greater reduction in viral index prior to study entry. Subject is willing to remain on anti-HBV therapy for the entire duration of the study; HCV-infected patients (HCV Ab or HCV RNA positive) who are judged to be stable by the investigator or who are on antiviral therapy at the time of enrolment and who continue to receive approved antiviral therapy during the study;
- Subjects with a history of (non-infectious) interstitial lung disease requiring systemic steroid therapy, or current interstitial lung disease/interstitial pneumonia; or subjects with Screening Imaging suggestive of suspected interstitial lung disease/interstitial pneumonia that cannot be ruled out;
- History of immunodeficiency, including being human immunodeficiency virus (HIV) positive or having other acquired, congenital immunodeficiency diseases;
- Poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L); and
- Active syphilis infection.
- Known tumour-associated spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks;
- Imaging suggestive of tumour invasion of large blood vessels or, in the judgement of the investigator, there is a high probability of tumour rupture or invasion of vital blood vessels during the study period leading to fatal haemorrhage;
- Failure to control a plasma (thoracic, abdominal, or pericardial) effusion that requires repeated drainage;
- Local radiotherapy within 2 weeks or >30% bone marrow irradiation radiotherapy for bone metastases within 4 weeks prior to first dose.
- Chemotherapy, targeted therapy, immunotherapy, or other antineoplastic agents within 4 weeks prior to the first dose, or who are still on drug 5.
- treatment, or subjects who are still within 5 half-lives of the drug (whichever occurs first);
- Prior use of epidermal growth factor receptor/c-mesenchymal epidermal transforming factor (EGFR/c-Met) dual-antibody drugs;
- Received treatment with a proprietary Chinese medicine with an anti-tumour indication as specified in the National Drug
- Administration (NMPA) approved drug insert within 1 week prior to study treatment.
- History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study period.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Not yet recruiting
National Cancer Center/Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, 100021
Ning Li, Doctor, 15601395554, lining@cicams.ac.cn
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Lixia Ma, Master, 13578670958, 13578670958@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yi He, Doctor, 18692237222, heyi@hnca.org.cn
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Xingye Wu, Doctor, 18696685221, wuxingye19830221@126.com
- Not yet recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Min Dong, Doctor, 13286800883, dongmin@mail.sysu.edu.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Zhiwei Li, Doctor, 15004683651, lzhw0451@163.com
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Jiqing Hao, Doctor, 13965029739, ayfy_hjq@163.com
- Not yet recruiting
Shandong Public Health Clinical Center
Jinan, Shandong, 250013
Jie Liu, Doctor, 15553119051, lj691012@126.com
- Not yet recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Xiwen Huang, Bachelor, 13751952289, 811253076@qq.com
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
RongFeng Song, Master, 13879172671, rfeng3471@163.com
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Sheng Li, Master, 13770768636, Lihsh198@163.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
Yanhong Gu, Doctor, 13813908678, Guyanhong@jsph.org.cn
- Not yet recruiting
Guangxi Zhuang Autonomous Region Cancer Hospital
Nanning, Guangxi, 530021
Yumei Zhang, Master, 13617716921, Zhzm05@163.com
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266011
Xiaomei Xu, Master, 18661675699, Xuxiaomei7171@qq.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhiyu Chen, Doctor, 13818197511, chanhj75@aliyun.com
- Not yet recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
XiuYing Xiao, Doctor, 13564579313, xiaoxiuying2002@163.com
- Not yet recruiting
Shantou University Medical College Affiliated Cancer Hospital
Shantou, Guangdong, 515031
Yi Jiang, Bachelor, 13553389578, jiangzy_123@sina.com
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Jinglei Qu, Doctor, 15904058133, qujinglei@hotmail.com
- Not yet recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002
Hui Yang, Bachelor, 13625281515, szslyyzlzxpiyh@163.com
- Not yet recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Yusheng Wang, Doctor, 13834646436, wangyusheng1972@163.com
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Hong Qiu, Doctor, 13986296106, tjqiuhong@163.com
- Not yet recruiting
Jiangnan University Affiliated Hospital
Wuxi, Jiangsu, 214000
Yong Mao, Doctor, 18651581690, mydoctorwx@aliyun.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Aili Suo, Doctor, 18991232561, ailisuo@mail.xjtu.edu.cn
- Not yet recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361004
Li Xiao, Doctor, 13906036392, xiaolibohan@163.com
Zhenyu Yin, Doctor, 13950120518, yinzy@xmu.edu.cn
- Not yet recruiting
Xinyang Central Hospital
Xinyang, Henan, 464000
Xiuqing Wang, Bachelor, 13569708115, 360675156@qq.com
- Not yet recruiting
Yibin First People's Hospital
Yibin, Sichuan, 644000
Zhiping Yuan, Doctor, 13568574713, yuanzhiping9@126.com
- Not yet recruiting
Zhoukou Central Hospital
Zhoukou, Henan, 466000
Keyou Xu, Bachelor, 13938095230, xky0394@163.com
About this study
Official title: A Phase Ib/II Clinical Study Evaluating TQB2922 for Injection and Chemotherapy in Combination With or Without Bevacizumab in Subjects With RAS/BRAF Wild-Type Advanced Colorectal Cancer Who Have Failed Chemotherapy
This is a multicenter, open Phase Ib/II clinical study evaluating the safety and efficacy of TQB2922 in combination with TAS-102±bevacizumab in subjects with RAS/BRAF wild-type unresectable locally advanced or metastatic colorectal cancer that has failed treatment with oxaliplatin, fluorouracil-based and irinotecan.
- Conditions
- RAS/BRAF Wild Type Colorectal Cancer
- Being tested
- TQB2922 injection ± TAS-102 tablets, TQB2922 injection+TAS-102 tablets ± Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2922 injection ± TAS-102 tabletsDrug
TQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype Immunoglobulin G1 (IgG1). TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells.
TQB2922 injection+TAS-102 tablets ± BevacizumabDrug
TQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype IgG1. TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells.
| Study group | Role | What they receive |
|---|---|---|
| TQB2922 injection + TAS-102 tablets | Experimental | Phase Ib: TQB2922 injection + TAS-102 tablets; TQB2922 is administered in the appropriate dose group, intravenously, every 28 days, once weekly in cycle 1 and every 2 weeks starting in cycle 2; TAS-102 tablets are administered at 35 mg/m2 (maximum 80 mg in a single dose), orally, twice daily, repeated every 28 days, on days 1 to 5 and 8 to 12. The dosage will be repeated every 28 days. Receives: Drug: TQB2922 injection ± TAS-102 tablets |
| TQB2922 injection | Experimental | Phase Ib: TQB2922 injection; TQB2922 is administered in the appropriate dose group, intravenously, every 28 days, once weekly in cycle 1 and every 2 weeks starting in cycle 2; TAS-102 tablets are administered at 35 mg/m2 (maximum 80 mg in a single dose), orally, twice daily, repeated every 28 days, on days 1 to 5 and 8 to 12. The dosage will be repeated every 28 days. Receives: Drug: TQB2922 injection ± TAS-102 tablets |
| TQB2922 injection+TAS-102 tablets + Bevacizumab | Experimental | Phase II: TQB2922 injection + TAS-102 tablets + bevacizumab; TQB2922 will be administered according to Recommended Phase 2 Dose (RP2D), one treatment cycle every 28 days, and once a week in the first cycle.
TQB2922 was administered according to RP2D, one treatment cycle every 28 days, once a week in the 1st cycle, and once every 2 weeks starting from the 2nd cycle; TAS-102 tablets were administered at 35 mg/m2 (maximum 80 mg in a single dose) orally twice a day on days 1-5 and 8-12, and repeated every 28 days; bevacizumab was administered at 5 mg/kg intravenously on the 1st day, and repeated every 2 weeks. Receives: Drug: TQB2922 injection+TAS-102 tablets ± Bevacizumab |
| TQB2922 injection+TAS-102 tablets | Experimental | Phase II: TQB2922 injection + TAS-102 tablets; TQB2922 will be administered according to RP2D, one treatment cycle every 28 days, and once a week in the first cycle.
TQB2922 was administered according to RP2D, one treatment cycle every 28 days, once a week in the 1st cycle, and once every 2 weeks starting from the 2nd cycle; TAS-102 tablets were administered at 35 mg/m2 (maximum 80 mg in a single dose) orally twice a day on days 1-5 and 8-12, and repeated every 28 days; bevacizumab was administered at 5 mg/kg intravenously on the 1st day, and repeated every 2 weeks. Receives: Drug: TQB2922 injection+TAS-102 tablets ± Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
One or more unacceptable toxic reactions following administration of the drug, resulting in the inability to continue increasing the dose or prolonging the dosing cycle.
Measured: Baseline up to 48 weeks
Objective Response Rate (ORR)
Proportion of patients with tumour volume reduction to a pre-specified value that maintains the minimum timeframe requirement.
Measured: Complete response time was achieved, evaluation is expected to take 1 years.
Secondary outcomes (12)
Maximum tolerated dose (MTD)
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
Measured: Baseline up to 48 weeks
Incidence of adverse event (AE) and serious adverse event (SAE)
The incidence and severity of adverse events were determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 rating scale
Measured: Baseline up to 48 weeks
Disease Control Rate (DCR)
The proportion of subjects who achieved complete response (CR), partial response (PR), or stable disease (SD) was assessed.
Measured: Complete response time was achieved, evaluation is expected to take 1 years.
Recommended Phase 2 Dose
The dose recommended for Phase 2 trials based on Phase 1 safety, tolerability, and pharmacokinetic data.
Measured: Baseline up to 48 weeks
Elimination Half-life
The time required for the plasma concentration of a drug to decrease by 50% during the elimination phase, reflecting metabolic and excretory rates.
Measured: Baseline up to 48 weeks
Area Under the Curve
The integral of the drug concentration-time curve in plasma, representing total systemic drug exposure.
Measured: Baseline up to 48 weeks
Apparent Clearance
The apparent volume of plasma cleared of the drug per unit time, typically expressed in L/h.
Measured: Baseline up to 48 weeks
Apparent Volume of Distribution in Terminal Phase
The apparent volume in which a drug is distributed during the terminal phase, calculated based on plasma concentration, indicating tissue distribution extent.
Measured: Baseline up to 48 weeks
Trough Concentration
The plasma drug concentration measured at the end of a dosing interval (before next administration), used to assess accumulation risk.
Measured: Baseline up to 48 weeks
Duration of Response
Time from first documented objective response (e.g., tumor shrinkage) to disease progression or death.
Measured: Complete response time was achieved, evaluation is expected to take 1 years.
Progression-Free Survival
Time from enrollment to disease progression or death from any cause, evaluating treatment's disease control ability.
Measured: 1 year of assessment is expected from the start of enrolment to the first occurrence of disease progression or death from any cause
Incidence of Anti-Drug Antibody
The proportion of patients developing antidrug antibodies during treatment, indicating immunogenicity risk.
Measured: Baseline up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start30 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAS/BRAF Wild Type Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044908
- Sponsor's protocol ID
- TQB2922-Ib/II-01
- Status last verified
- Apr 2025
- First submitted
- 23 Jun 2025
- Last updated
- 12 Aug 2025
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study Evaluating TQB2922 for Injection and Chemotherapy in Combination With or Without Bevacizumab in Subjects With RAS/BRAF Wild-Type Advanced Colorectal Cancer Who Have Failed Chemotherapy
- ClinicalTrials.gov ID
- NCT07044908
- Acronym / sponsor ID
- TQB2922-Ib/II-01
- Conditions
- RAS/BRAF Wild Type Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 1 Jul 2025 (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 is a multicenter, open Phase Ib/II clinical study evaluating the safety and efficacy of TQB2922 in combination with TAS-102±bevacizumab in subjects with RAS/BRAF wild-type unresectable locally advanced or metastatic colorectal cancer that has failed treatment with oxaliplatin, fluorouracil-based and irinotecan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TQB2922 injection + TAS-102 tablets | Experimental | Drug: TQB2922 injection ± TAS-102 tabletsPhase Ib: TQB2922 injection + TAS-102 tablets; TQB2922 is administered in the appropriate dose group, intravenously, every 28 days, once weekly in cycle 1 and every 2 weeks starting in cycle 2; TAS-102 tablets are administered at 35 mg/m2 (maximum 80 mg in a single dose), orally, twice daily, repeated every 28 days, on days 1 to 5 and 8 to 12. The dosage will be repeated every 28 days. |
| TQB2922 injection | Experimental | Drug: TQB2922 injection ± TAS-102 tabletsPhase Ib: TQB2922 injection; TQB2922 is administered in the appropriate dose group, intravenously, every 28 days, once weekly in cycle 1 and every 2 weeks starting in cycle 2; TAS-102 tablets are administered at 35 mg/m2 (maximum 80 mg in a single dose), orally, twice daily, repeated every 28 days, on days 1 to 5 and 8 to 12. The dosage will be repeated every 28 days. |
| TQB2922 injection+TAS-102 tablets + Bevacizumab | Experimental | Drug: TQB2922 injection+TAS-102 tablets ± BevacizumabPhase II: TQB2922 injection + TAS-102 tablets + bevacizumab; TQB2922 will be administered according to Recommended Phase 2 Dose (RP2D), one treatment cycle every 28 days, and once a week in the first cycle. TQB2922 was administered according to RP2D, one treatment cycle every 28 days, once a week in the 1st cycle, and once every 2 weeks starting from the 2nd cycle; TAS-102 tablets were administered at 35 mg/m2 (maximum 80 mg in a single dose) orally twice a day on days 1-5 and 8-12, and repeated every 28 days; bevacizumab was administered at 5 mg/kg intravenously on the 1st day, and repeated every 2 weeks. |
| TQB2922 injection+TAS-102 tablets | Experimental | Drug: TQB2922 injection+TAS-102 tablets ± BevacizumabPhase II: TQB2922 injection + TAS-102 tablets; TQB2922 will be administered according to RP2D, one treatment cycle every 28 days, and once a week in the first cycle. TQB2922 was administered according to RP2D, one treatment cycle every 28 days, once a week in the 1st cycle, and once every 2 weeks starting from the 2nd cycle; TAS-102 tablets were administered at 35 mg/m2 (maximum 80 mg in a single dose) orally twice a day on days 1-5 and 8-12, and repeated every 28 days; bevacizumab was administered at 5 mg/kg intravenously on the 1st day, and repeated every 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects voluntarily enrolled in the study, signed the informed consent and had good compliance;
- Age: 18-75 years old (including boundaries at the time of signing the informed consent);
- Eastern Cooperative Oncology Group (ECOG) score: 0-1;
- Expected survival of more than 3 months;
- Unresectable locally advanced or metastatic colorectal cancer diagnosed by histological/cytological pathology;
Key exclusion criteria (28 listed)
- Patients who have had previous confirmation of microsatellite high instability/mismatch repair defects (MSI-H/dMMR) by immunohistochemistry (IHC), next-generation sequencing (NGS) or polymerase chain reaction (PCR);
- Presence of a disease that interferes with intravenous administration, intravenous blood collection, or multiple factors that interfere with oral administration of medications (e.g., inability to swallow, chronic diarrhoea and intestinal obstruction);
- Active inflammatory bowel disease (ulcerative colitis, Crohn's disease) within 28 days prior to first dose;
- The presence or current concurrent presence of other malignancies within 2 years prior to the first dose.
- Unresolved toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to any prior therapy, excluding alopecia, fatigue and peripheral neuropathy;
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 ± TAS-102 tabletsTQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype Immunoglobulin G1 (IgG1). TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells. | Drug | TQB2922 injection, TQB2922 injection + TAS-102 tablets |
| TQB2922 injection+TAS-102 tablets ± BevacizumabTQB2922 is an anti-EGFR/c-Met bispecific antibody, subtype IgG1. TQB2922 blocks the activation of EGFR and c-Met signalling pathway by binding to EGFR and c-Met on the surface of tumour cells, thus preventing tumour growth and progression. At the same time, TQB2922 can target EGFR and c-Met on the surface of tumour cells through antibody-dependent cytotoxicity (ADCC) and antibody-dependent cell phagocytosis by natural killer cells and macrophages, thus killing tumour cells. | Drug | TQB2922 injection+TAS-102 tablets, TQB2922 injection+TAS-102 tablets + Bevacizumab |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Baseline up to 48 weeks
One or more unacceptable toxic reactions following administration of the drug, resulting in the inability to continue increasing the dose or prolonging the dosing cycle.
Objective Response Rate (ORR)
Time frame: Complete response time was achieved, evaluation is expected to take 1 years.
Proportion of patients with tumour volume reduction to a pre-specified value that maintains the minimum timeframe requirement.
12 secondary outcomes
Maximum tolerated dose (MTD)
Time frame: Baseline up to 48 weeks
Incidence of adverse event (AE) and serious adverse event (SAE)
Time frame: Baseline up to 48 weeks
Disease Control Rate (DCR)
Time frame: Complete response time was achieved, evaluation is expected to take 1 years.
Recommended Phase 2 Dose
Time frame: Baseline up to 48 weeks
Elimination Half-life
Time frame: Baseline up to 48 weeks
Area Under the Curve
Time frame: Baseline up to 48 weeks
Apparent Clearance
Time frame: Baseline up to 48 weeks
Apparent Volume of Distribution in Terminal Phase
Time frame: Baseline up to 48 weeks
Trough Concentration
Time frame: Baseline up to 48 weeks
Duration of Response
Time frame: Complete response time was achieved, evaluation is expected to take 1 years.
Progression-Free Survival
Time frame: 1 year of assessment is expected from the start of enrolment to the first occurrence of disease progression or death from any cause
Incidence of Anti-Drug Antibody
Time frame: Baseline up to 48 weeks
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 12 Aug 2025.
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Colorectal Cancer
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.
27 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 ± TAS-102 tablets and TQB2922 injection+TAS-102 tablets ± Bevacizumab in people with RAS/BRAF Wild Type Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 27 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 11 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 Suxia Luo, Master (18638553211, luosxrm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Baseline up to 48 weeks). The study lists 2 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 12 Aug 2025.