Advanced Solid TumorsPhase 1/2NCT07019779
Study of CM518D1 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing CM518D1 in people with Advanced Solid Tumors, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CM518D1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2025to 31 Dec 2029
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female ≥ 18 and ≤75 years of age.
- 2. Subjects with histologically or cytologically confirmed advanced solid tumors.
- 3. At least one measurable lesion according to RECIST v1.1.
- 4. Expected survival time ≥ 3 months as judged by the Investigator.
Who cannot join
- 1. Subjects who have received any chemotherapy or any drug therapy for antitumor treatment including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates(ADCs), or any investigational product therapy for anti-tumor therapy within 28 days prior to the first dose or within 5 half-lives (whichever is shorter).
- 2. Subjects who have received major surgery within 28 days prior to the first dose.
- 3. Subjects who have received radiotherapy within 21 days prior to the first dose.
- 4. Subjects who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose.
- 5. Subjects who have received any CDH17-targeted therapy.
- 6. History of other malignancies within 5 years prior to the first dose, excluding cured basal or squamous cell carcinoma of skin, carcinoma cervix in situ, or breast ductal carcinoma in situ.
- 7. Hypersensitivity to the investigational drug or its excipients.
- 8. Pregnant or lactating female patients.
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
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong
Ruihua Xu, Dr., 020-87343468, xurh@sysucc.org.cn
Ruihua Xu, Dr.
About this study
Official title: A Multicenter, Open-Label, Phase I/II Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors
This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- CM518D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM518D1Biological
CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.
CM518D1Biological
CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).
CM518D1Biological
CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Phase I dose escalation | Experimental | Not described Receives: Biological: CM518D1 |
| Phase I dose expansion | Experimental | Not described Receives: Biological: CM518D1 |
| Phase II | Experimental | Not described Receives: Biological: CM518D1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)-Phase I dose escalation
DLT is defined as a toxicity occurring during the DLT observation period.
Measured: First cycle (21 days)
Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation
An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
Measured: Through study completion, an average of 2 years.
Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose expansion
An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
Measured: Through study completion, an average of 2 years.]
Preliminary efficacy-Phase I dose expansion
Preliminary efficacy includes objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS).
Measured: Through study completion, an average of 2 years.]
Objective response rate (ORR)-Phase II
ORR is defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors( RECIST) v1.1.
Measured: Through study completion, an average of 2 years.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start27 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019779
- Sponsor's protocol ID
- CM518D1-030101
- Status last verified
- Jun 2026
- First submitted
- 26 May 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase I/II Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07019779
- Acronym / sponsor ID
- CM518D1-030101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Jun 2025 (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 an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I dose escalation | Experimental | Biological: CM518D1 |
| Phase I dose expansion | Experimental | Biological: CM518D1 |
| Phase II | Experimental | Biological: CM518D1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Male or female ≥ 18 and ≤75 years of age.
- 2. Subjects with histologically or cytologically confirmed advanced solid tumors.
- 3. At least one measurable lesion according to RECIST v1.1.
- 4. Expected survival time ≥ 3 months as judged by the Investigator.
Key exclusion criteria (8 listed)
- 1. Subjects who have received any chemotherapy or any drug therapy for antitumor treatment including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates(ADCs), or any investigational product therapy for anti-tumor therapy within 28 days prior to the first dose or within 5 half-lives (whichever is shorter).
- 2. Subjects who have received major surgery within 28 days prior to the first dose.
- 3. Subjects who have received radiotherapy within 21 days prior to the first dose.
- 4. Subjects who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose.
- 5. Subjects who have received any CDH17-targeted therapy.
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 |
|---|---|---|
| CM518D1CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels. | Biological | Phase I dose escalation |
| CM518D1CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D). | Biological | Phase I dose expansion |
| CM518D1CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts. | Biological | Phase II |
Primary outcome
Dose Limiting Toxicity (DLT)-Phase I dose escalation
Time frame: First cycle (21 days)
DLT is defined as a toxicity occurring during the DLT observation period.
Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation
Time frame: Through study completion, an average of 2 years.
An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose expansion
Time frame: Through study completion, an average of 2 years.]
An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
Preliminary efficacy-Phase I dose expansion
Time frame: Through study completion, an average of 2 years.]
Preliminary efficacy includes objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS).
Objective response rate (ORR)-Phase II
Time frame: Through study completion, an average of 2 years.]
ORR is defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors( RECIST) v1.1.
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 15 Jun 2026.
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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.
Ruihua Xu principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM518D1 in people with Advanced Solid Tumors, run by Keymed Biosciences Co.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 4 inclusion and 8 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 15 Jun 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Qian Jia (028-88610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT)-Phase I dose escalation (time frame: First cycle (21 days)). The study lists 5 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 15 Jun 2026.