TQB2922 and TAS-102 Tablets for Injection With or Without Bevacizumab in Chemotherapy-failed RAS/BRAF Wild-type Advanced Colorectal Cancer

NCT07044908 | Recruiting Phase 1

• 1 other identifier: TQB2922-Ib/II-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

RAS/BRAF Wild Type Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Complete response time was achieved, evaluation is expected to take 1 years.

Secondary Outcomes (12)

• Maximum tolerated dose (MTD)

  Baseline up to 48 weeks

• Incidence of adverse event (AE) and serious adverse event (SAE)

  Baseline up to 48 weeks

• Disease Control Rate (DCR)

  Complete response time was achieved, evaluation is expected to take 1 years.

• Recommended Phase 2 Dose

  Baseline up to 48 weeks

• Elimination Half-life

  Baseline up to 48 weeks

Study Arms (4)

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.

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.

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.

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.

Drug: TQB2922 injection+TAS-102 tablets ± Bevacizumab

Interventions

TQB2922 injection ± TAS-102 tablets DRUG

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; TQB2922 injection + TAS-102 tablets

TQB2922 injection+TAS-102 tablets ± Bevacizumab DRUG

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.

TQB2922 injection+TAS-102 tablets; TQB2922 injection+TAS-102 tablets + Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (27)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

NOT YET RECRUITING

National Cancer Center/Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

NOT YET RECRUITING

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361004, China

NOT YET RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

NOT YET RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, 514031, China

NOT YET RECRUITING

Shantou University Medical College Affiliated Cancer Hospital

Shantou, Guangdong, 515031, China

NOT YET RECRUITING

Guangxi Zhuang Autonomous Region Cancer Hospital

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Xinyang Central Hospital

Xinyang, Henan, 464000, China

NOT YET RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, 466000, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215002, China

NOT YET RECRUITING

Jiangnan University Affiliated Hospital

Wuxi, Jiangsu, 214000, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

NOT YET RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

NOT YET RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

NOT YET RECRUITING

Shandong Public Health Clinical Center

Jinan, Shandong, 250013, China

NOT YET RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

NOT YET RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

NOT YET RECRUITING

Yibin First People's Hospital

Yibin, Sichuan, 644000, China

NOT YET RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Suxia Luo, Master

CONTACT

18638553211; luosxrm@163.com

Shegan Gao, Doctor

CONTACT

18639859977; gsg112258@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-04

Locations

CN (27)