Colorectal Cancer MetastaticPhase 2NCT06589830
TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer
A Phase 2 study testing TL938 Capsules and Trastuzumab in people with Colorectal Cancer Metastatic and Advanced Colorectal Cancer, run by Suzhou Teligene Ltd. at 1 site in China.
Trial summary
This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Advanced Colorectal Cancer
- What is being tested?
- TL938 Capsules and Trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2025to Oct 2027
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old and above, male or female;
- 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;
- At least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;
- A minimum life expectancy of >3 months;
- Adequate bone marrow reserve, hepatic, renal, and coagulation function;
- Other inclusion criteria apply for participating in the Study. -
Who cannot join
- Prior anti-HER2 targeting therapy;
- 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;
- Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);
- Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;
- Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;
- Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible;
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- 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;
- Any active infection which has not been controlled at screening;
- Other exclusion criteria apply for participating in the Study. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yuankai Shi, Doctor of Medicine, 8610-67781331, syuankaipumc@126.com
About this study
Official title: A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer
This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.
- Being tested
- TL938 Capsules, Trastuzumab
- Keywords
- Oncology, TL938, Colorectal Cancer, HER2
- Medical subject headings
- Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL938 CapsulesDrug
Oral administration
TrastuzumabDrug
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| TL938-Trastuzumab combination | Experimental | TL938-Trastuzumab combination receives TL938 capsules by mouth once daily. Trastuzumab given intravenously on Day 1 of each Cycle. Cycle length is 21 days Receives: Drug: TL938 Capsules; Drug: Trastuzumab |
| TL938 | Experimental | TL938 monotherapy receives TL938 capsules by mouth once daily. Cycle length is 21 days. Receives: Drug: TL938 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose
Measured: Pre-dose up to approximately 24 months post-dose
Objective Response Rate (ORR) by IRC
Measured: Pre-dose up to approximately 24 months post-dose
Secondary outcomes (21)
Objective Response Rate (ORR) by Investigator
Measured: Pre-dose up to approximately 24 months post-dose
Duration of Response (DoR)
Measured: Pre-dose up to approximately 24 months post-dose
Disease Control Rate (DCR)
Measured: Pre-dose up to approximately 24 months post-dose
Progression Free Survival (PFS)
Measured: Pre-dose up to approximately 24 months post-dose
Time to Tumor Progression (TTP)
Measured: Pre-dose up to approximately 24 months post-dose
Time to Treatment Failure (TTF)
Measured: Pre-dose up to approximately 24 months post-dose
Time to Response (TTR)
Measured: Pre-dose up to approximately 24 months post-dose
Overall Survival (OS)
Measured: Pre-dose up to approximately 24 months post-dose
1-year Progression Free Survival
Measured: Pre-dose up to approximately 24 months post-dose
1-year Survival
Measured: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Events (AE)
Measured: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Measured: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)
Measured: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Reactions (SAR)
Measured: Pre-dose up to approximately 24 months post-dose
Area Under The Curve (AUC) of TL938
Measured: Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of TL938
Measured: Pre-dose up to 24 hours post-dose
Minimum Plasma Concentration (Cmin) of TL938
Measured: Pre-dose up to 24 hours post-dose
Time to Peak Drug Concentration (Tmax) of TL938
Measured: Pre-dose up to 24 hours post-dose
TL938 half-life (T1/2)
Measured: Pre-dose up to 24 hours post-dose
Volume of Distribution (Vz/F) of TL938
Measured: Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of TL938
Measured: Pre-dose up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 May 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Teligene Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589830
- Sponsor's protocol ID
- TL-HER-202301
- Status last verified
- Apr 2026
- First submitted
- 6 Sep 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06589830
- Acronym / sponsor ID
- TL-HER-202301
- Keywords
- Oncology, TL938, Colorectal Cancer, HER2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Suzhou Teligene Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Sep 2024 (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 Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TL938-Trastuzumab combination | Experimental | Drug: TL938 Capsules, Drug: TrastuzumabTL938-Trastuzumab combination receives TL938 capsules by mouth once daily. Trastuzumab given intravenously on Day 1 of each Cycle. Cycle length is 21 days |
| TL938 | Experimental | Drug: TL938 CapsulesTL938 monotherapy receives TL938 capsules by mouth once daily. Cycle length is 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years old and above, male or female;
- 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;
- At least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;
- A minimum life expectancy of >3 months;
Key exclusion criteria (9 listed)
- Prior anti-HER2 targeting therapy;
- 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;
- Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);
- Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;
- Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;
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 |
|---|---|---|
| TL938 CapsulesOral administration | Drug | TL938, TL938-Trastuzumab combination |
| TrastuzumabIntravenous (IV) infusion | Drug | TL938-Trastuzumab combination |
Primary outcome
Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose
Time frame: Pre-dose up to approximately 24 months post-dose
Objective Response Rate (ORR) by IRC
Time frame: Pre-dose up to approximately 24 months post-dose
21 secondary outcomes
Objective Response Rate (ORR) by Investigator
Time frame: Pre-dose up to approximately 24 months post-dose
Duration of Response (DoR)
Time frame: Pre-dose up to approximately 24 months post-dose
Disease Control Rate (DCR)
Time frame: Pre-dose up to approximately 24 months post-dose
Progression Free Survival (PFS)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Tumor Progression (TTP)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Treatment Failure (TTF)
Time frame: Pre-dose up to approximately 24 months post-dose
Time to Response (TTR)
Time frame: Pre-dose up to approximately 24 months post-dose
Overall Survival (OS)
Time frame: Pre-dose up to approximately 24 months post-dose
1-year Progression Free Survival
Time frame: Pre-dose up to approximately 24 months post-dose
1-year Survival
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Events (AE)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)
Time frame: Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Reactions (SAR)
Time frame: Pre-dose up to approximately 24 months post-dose
Area Under The Curve (AUC) of TL938
Time frame: Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of TL938
Time frame: Pre-dose up to 24 hours post-dose
Minimum Plasma Concentration (Cmin) of TL938
Time frame: Pre-dose up to 24 hours post-dose
Time to Peak Drug Concentration (Tmax) of TL938
Time frame: Pre-dose up to 24 hours post-dose
TL938 half-life (T1/2)
Time frame: Pre-dose up to 24 hours post-dose
Volume of Distribution (Vz/F) of TL938
Time frame: Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of TL938
Time frame: Pre-dose up to 24 hours post-dose
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 28 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TL938 Capsules and Trastuzumab in people with Colorectal Cancer Metastatic and Advanced Colorectal Cancer, run by Suzhou Teligene Ltd. at 1 site 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 7 inclusion and 9 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 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 Xiaoyang Xia (8053009373, Xiaoyang.xia@teligene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose (time frame: Pre-dose up to approximately 24 months post-dose). 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 28 Apr 2026.