New hope for Hard-to-Treat colorectal cancer: drug combo enters Mid-Stage trial
NCT ID NCT06589830
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial is testing whether a new drug called TL938, taken as a pill, combined with the targeted therapy trastuzumab (given by IV), can shrink tumors in people with HER2-positive colorectal cancer that has spread or come back. The study will enroll 80 adults who have already tried several standard treatments. Researchers aim to find the best dose and measure how many patients respond to the combination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TL938 capsules and trastuzumab (injection)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with HER2-positive colorectal cancer that has spread and not responded to standard therapies.
- What could go wrong
- This is an early Phase 2 trial with only 80 participants, so results may not apply to all patients. The drug combination may cause side effects or fail to shrink tumors in many participants.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 years old and above, male or female; 2. Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb; 3. At least one measurable lesion; 4. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2; 5. A minimum life expectancy of \>3 months; 6. Adequate bone marrow reserve, hepatic, renal, and coagulation function; 7. Other inclusion criteria apply for participating in the Study. - Exclusion Criteria: 1. Prior anti-HER2 targeting therapy; 2. Any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment; 3. Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter); 4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment; 5. Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening; 6. Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible; 7. Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast; 8. Any active infection which has not been controlled at screening; 9. Other exclusion criteria apply for participating in the Study. -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a vaccine boost immunotherapy against a stubborn cancer?
- What does recovery really look like after aggressive peritoneal cancer surgery?
- Can a new drug combo shrink Hard-to-Treat colorectal tumors?
- Chemo holidays put to the test: can scheduled breaks beat continuous treatment for advanced colorectal cancer?
- Can two immune boosters outsmart Chemo-Resistant colon cancer?