New drug combo aims to improve First-Line colorectal cancer treatment

NCT ID NCT07462143

Disease control Sponsor: RemeGen Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called RC148 combined with chemotherapy as a first treatment for people with advanced colorectal cancer that cannot be surgically removed. About 80 participants will receive either RC148 plus chemo or the standard bevacizumab plus chemo. The goal is to see if the new combination works better at shrinking tumors.

What this could mean

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

Active substance: RC148 (a drug) combined with chemotherapy (capecitabine and oxaliplatin)
What this could lead to: If it works, this could offer a new first-line treatment option for people with advanced colorectal cancer that cannot be removed by surgery.
What could go wrong: This is an early-to-mid stage trial with only 80 participants, so results may not apply to everyone. The new drug combination may not be more effective or safer than the current standard treatment.

Why investors are watching

Remegen is testing RC148 combined with chemotherapy against a standard bevacizumab plus chemotherapy regimen as a first-line treatment for unresectable or metastatic colorectal cancer. This is a small, early-stage trial with only 80 planned participants, but for a small-cap company, a positive efficacy or safety signal could validate RC148 as a viable candidate and support further development. The result matters because it directly affects the company's pipeline value and its ability to advance this drug.

If it works: A positive result could show that RC148 works as well as or better than a standard treatment, which might encourage Remegen to move the drug into larger trials. It could also strengthen the company's position in the colorectal cancer market.

If it fails: A failure or delay could set back the drug's development and hurt the company's prospects, since trials often fail to meet their goals. With only 80 participants, the results may also be too small to draw firm conclusions, adding uncertainty.

AI-written from the trial record. Speculative, and not investment advice.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 80 people

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

Started

May 2026

Expected to finish

Dec 2030

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: 1. Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol. 2. Aged 18-75 years old (including 18 years old and 75 years old). 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Expected survival period ≥ 12 weeks. 5. At least one measurable lesion according to RECIST v1.1 criteria. 6. Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage. 7. Subjects must be able to provide tumor tissue samples for biomarker detection. 8. Adequate bone marrow, liver, kidney, and coagulation function. 9. Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment. Exclusion Criteria: 1. Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR). 2. Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding. 3. Subjects with brain metastases. 4. Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0. 5. Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs. 6. Subjects with refractory nausea and vomiting, chronic gastrointestinal diseases, or other diseases that may interfere the adequate absorption, distribution, metabolism, or excretion of oral drugs. 7. Subjects with acute, chronic, or symptomatic infections. 8. Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases. 9. Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction. 10. Subjects with severe arterial/venous thromboembolic events within 6 months before randomization. 11. Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis. 12. Presence of symptomatic or intervention-requiring third-space effusions. 13. Subjects with active or previously diagnosed autoimmune diseases that may recur. 14. History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors. 15. Subjects who are pregnant, lactating, or planning to become pregnant.

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer

As listed by the trial registrant

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

Colorectal (colon or rectal) cancer

How to take part

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

The places running it

19 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 Hospital of Jiangnan University
RECRUITING

Wuxi, Jiangsu, China
Beijing Cancer Hospital
RECRUITING

Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
RECRUITING

Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
RECRUITING

Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
RECRUITING

Fuzhou, Fujian, China
Guangxi Medical University Cancer Hospital
RECRUITING

Nanjing, Guangxi, China
Jiangsu Cancer Hospital
RECRUITING

Nanjing, Jiangsu, China
Meizhou People's Hospital
RECRUITING

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

Tianjin, Tianjin Municipality, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING

Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
RECRUITING

Taiyuan, Shanxi, China
The First Affiliated Hospital of Zhengzhou University
RECRUITING

Zhengzhou, Henan, China
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
RECRUITING

Shijiazhuang, Hebei, China
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING

Hangzhou, Zhejiang, China
The first hospital of Jilin University
RECRUITING

Changchun, Jilin, China
Tongji Medical College of Huazhong University of Science &Technology
RECRUITING

Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING

Wuhan, Hubei, China
West China Hospital of Sichuan University
RECRUITING

Chengdu, Sichuan, China
Yunnan Cancer Hospital
RECRUITING

Kunming, Yunnan, China

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