New hope for Hard-to-Treat colorectal cancer: targeted drug TQB2102 enters phase 3 trial

NCT ID NCT07483684

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a new drug called TQB2102, which delivers chemotherapy directly to HER2-positive cancer cells, in people with advanced colorectal cancer that has stopped responding to standard treatments. About 142 participants will be randomly assigned to receive either TQB2102 or one of several standard chemotherapy options. The study aims to see if TQB2102 can delay cancer growth and improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TQB2102 (a next-generation antibody-drug conjugate targeting HER2)
What this could lead to: If successful, this could offer a new treatment option for people with HER2-positive advanced colorectal cancer who have run out of standard therapies.
What could go wrong: This is an early Phase 3 trial with only 142 participants, so results may not apply to everyone. The drug may not improve survival or could have side effects like other cancer treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The subject voluntarily participates in this study, signs the informed consent form, and has good compliance. * Aged 18 to 75 years old (calculated as of the date of signing the informed consent form). * Subjects with histologically or cytologically confirmed advanced colorectal cancer. * The subject has confirmed HER2 IHC3+ status in tumor tissue, as determined by the central laboratory designated by the sponsor. * The subject must provide a sufficient quantity of qualified tumor specimens (fresh or archived samples collected within the past 3 years from primary or metastatic lesions) for central laboratory testing of HER2 status. * Advanced colorectal cancer that has progressed on or been intolerant to at least 2 prior lines of standard therapy (defined as disease progression or intolerable toxicity during or within 3 months after the last standard therapy). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Expected survival of greater than 12 weeks. * Presence of at least one measurable lesion as confirmed by RECIST 1.1 criteria. * Laboratory tests must meet criteria * Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the study ends, and have a negative serum or urine pregnancy test within 7 days prior to study entry. Men must agree to use effective contraception during the study and for 6 months after the study ends. Exclusion Criteria: * A history of other malignant tumors within 3 years prior to the first dose, or concurrent malignant tumors at screening. Subjects are eligible for enrollment if they meet one of the following two conditions: * Other malignant tumors treated with curative intent via a single surgical procedure, with disease-free survival (DFS) maintained for 5 consecutive years; * A history of cured carcinoma in situ of the cervix, non-melanoma skin cancer, or superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\]. * Presence of diseases that affect intravenous injection or venous blood collection, or factors that impair oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.). * Failure of adverse reactions from prior treatments to resolve to ≤ Grade 1 per CTCAE v5.0, with the following exceptions: Grade 2 alopecia, Grade 2 peripheral neurotoxicity, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, type 1 diabetes mellitus and hypothyroidism stabilized with hormone replacement therapy, and other toxicities judged by the investigator to pose no safety risks. * Receipt of major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose; or planned major surgery during the study period (excluding surgeries specified in the protocol); or presence of unhealed wounds or fractures for a prolonged period. * Clinically significant tumor bleeding or perforation within 1 month prior to the first dose; or any bleeding event ≥ Grade 3 per CTCAE v5.0; or subjects with bleeding or coagulation disorders receiving warfarin, aspirin, or other antiplatelet agents (excluding maintenance doses: aspirin ≤ 100 mg/day, clopidogrel ≤ 75 mg/day); or subjects with a history or signs of bleeding deemed ineligible by the investigator. * A history of thrombotic or embolic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis (DVT) \[excluding subjects with isolated calf vein thrombosis ≤ 7 mm in diameter, ≤ 5 cm in length, not involving ≥ 2 veins, and assessed by the investigator as having no risk of thrombus progression\], and pulmonary embolism, etc. * Presence of major cardiovascular diseases. * A history of decompensated liver cirrhosis or hepatic encephalopathy. * Subjects with active chronic hepatitis B or active chronic hepatitis C. Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening must undergo additional testing for Hepatitis B Virus (HBV) DNA titer or HCV RNA quantification. * Active syphilis infection requiring treatment. * A history of (non-infectious) pneumonitis/interstitial lung disease requiring corticosteroid therapy; or current diagnosis of non-infectious pneumonitis/interstitial lung disease; or hospitalization for any active infection or receipt of therapeutic antibiotics within 4 weeks prior to the start of study treatment, including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. * Active or uncontrolled severe infection (≥ Grade 2 infection per CTCAE v5.0). * A history of psychoactive substance abuse with inability to abstain, or presence of mental disorders. * A history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. * Tumor-related symptoms and treatments. * Known hypersensitivity or allergic reaction to any study drug or its excipients. * Prior receipt of anti-HER2 antibody-drug conjugate (ADC) therapy. * Receipt of any anticancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) or any other investigational drug therapy within 4 weeks or 5 half-lives prior to the first dose of this study, whichever is shorter. * Pregnant or lactating subjects. * Vaccination with live-attenuated vaccines within 28 days prior to the start of study treatment, or inactivated vaccines within 7 days prior; or planned vaccination during the study period. * Any other condition judged by the investigator to pose a serious risk to subject safety or interfere with the subject's completion of the study.

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Conditions

The condition(s) this trial relates to.

colorectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2 IHC3+ advanced colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

48 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China
Affiliated Hospital of Jining Medical University

Jining, Shandong, 272029, China
Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China
Anhui Provincial Cancer Hospital

Hefei, Anhui, 230000, China
Anhui Provincial Cancer Hospital

Hefei, Anhui, 230000, China
Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China
Cancer Hospital Chinese Academy pf Medical Seciences

Langfang, Hebei, 650000, China
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)

Jinan, Shandong, 250117, China
First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 300010, China
Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China
Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China
Gansu Provincial Cancer Hospital

Lanzhou, Gansu, 730050, China
Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530000, China
Harbin Medical University Affiliated Fourth Hospital

Harbin, Heilongjiang, 150006, China
Henan Cancer Hospital

Zhengzhou, Henan, 450008, China
Hubei Cancer Hospital

Wuhan, Hubei, 430079, China
Hunan Cancer Hospital

Changsha, Hunan, 410000, China
Introduction Of Shanxi Cancer Hospital

Taiyuan, Shanxi, 300000, China
Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China
Jilin Cancer Hospital

Changchun, Jilin, 130000, China
Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China
Linyi Cancer Hospital

Linyi, Shandong, 276034, China
Linyi people's Hospital

Linyi, Shandong, 276000, China
Meizhou People's Hospital(Huangtang Hospital) Meizhou Academy of Medical Sciences

Meizhou, Guangdong, 514000, China
People's Hospital of Tianjin

Tianjin, Tianjin Municipality, 300121, China
Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China
Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China
Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710061, China
Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China
Sichuan Academy of Medical Science&Sichuan Provincial People' Hospital

Chengdu, Sichuan, 610000, China
Sichuan Provincial Cancer Hospital (Sichuan Provincial Cancer Prevention and Treatment Center of the Second People's Hospital of Sichuan Province)

Chengdu, Sichuan, 610041, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China
Sun Yat-sen university cancer center

Guangzhou, Guangdong, 510050, China
The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330000, China
The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110801, China
The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Xi 'An Jiaotong University

Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China
The People's Hospital of Guizhou Province

Guiyang, Guizhou, 550002, China
The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310017, China
The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570311, China
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )

Xi'an, Shaanxi, 710004, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China
The first affiliated hostpital of guangzhou medical university (national center for respiratory medicine)

Guangzhou, Guangdong, 510000, China
Yunnan Cancer Hospital

Kunming, Yunnan, 650000, China
ZhongShan Hospital

Shanghai, Shanghai Municipality, 200030, China