Patients With Advanced Solid TumorsPhase 1/2NCT07664150
CW-301 FIH Study of CAN016
A Phase 1/2 study testing CAN016 in people with Patients With Advanced Solid Tumors, run by Canwell Biotech Limited at 1 site in China.
Trial summary
A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced Solid Tumors
- What is being tested?
- CAN016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2026to 30 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide informed consent voluntarily
- Male or female patients ≥18 years of age.
- Patients must have a histologically or cytologically confirmed diagnosis of recurrent or metastatic HER2 expression or mutation advanced solid tumor that has failed to or intolerable with standard treatment.
- For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted ADC and should be refractory to or intolerant of exiting therapy(ies) known to provide clinical benefit for their condition;
- For Phase II, patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer, HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer and other HER2 expression or mutation advanced solid tumors are eligible. Patients must have had progression of disease on prior HER2 targeted ADC.
- At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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- Adequate organ function with 7 days before registration
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- LVEF ≥50% by either echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before registration.
- Life expectancy of ≥3 months.
Who cannot join
- Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.
- Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
- Patients have autologous transplantation within 3 months.
- Major surgery or had significant traumatic injury within 60 days prior to the first dose of the investigational product or has not recovered from major side effects.
- Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease.
- Any toxicities from prior treatment that have not recovered to baseline or ≤CTCAE Grade 1 before the start of study treatment, with exception of hair loss.
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, 100021
Binghe Xu, MD,PhD, +86 010-67781331, xubinghe@medmail.com.cn
About this study
Official title: A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients With Advanced Solid Tumors
A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors
Read the detailed description
This is a Phase I/II, Open-Label, Non-Randomized, Multi-centre First-in-Human Study.
Phase I:
Accelerated Titration Designs and 3+3 escalation design for MTD and/or RP2D determination.
Phase II:
Once the RP2D is determined, the study will enroll patients into Phase II. Approximately 20~60 patients will be enrolled to evaluate the efficacy of CAN016 in HER2 expression or mutation advanced solid tumors.
- Conditions
- Patients With Advanced Solid Tumors
- Being tested
- CAN016
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN016Drug
CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met.
CAN016Drug
an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1. A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed. Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD), or withdrawal of consent, death, lost to follow-up (F/U), or other discontinuation criteria is met
| Study group | Role | What they receive |
|---|---|---|
| patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer | Experimental | CAN016 Receives: Drug: CAN016 |
| HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer | Experimental | CAN016 Receives: Drug: CAN016 |
| HER2 expression or mutation advanced solid tumors | Experimental | CAN016 Receives: Drug: CAN016 |
| For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted AD | Experimental | CAN016 Receives: Drug: CAN016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
Incidence rate of dose limiting toxicities (DLT) in the first cycle (of 21 days) of each investigated dose levels.
Measured: 12 months
Tumor objective response rate (ORR)
Tumor objective response rate (ORR) defined as the sum of complete response (CR) rate and partial response (PR) rate as best reported by Response Evaluation Criteria in Solid Tumors (RECIST1.1)
Measured: 36 months
Secondary outcomes (8)
Safety and Tolerability
AE type, incidence, duration, severity and seriousness of AEs, physical examination, laboratory data, vital signs and ECG changes according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0.
Measured: 48 months
Pharmacokinetic measures - concentration time Area Under the Curves
Measure the variation of CAN016 concentration in blood as a function time
Measured: 12 months
Pharmacokinetic measures - Cmax
Measure the maximum (peak) blood concentration(s) of CAN016
Measured: 12 months
Pharmacokinetic measures - Tmax
Measure of time to reach maximum (peak) blood concentration(s) following administration of CAN016
Measured: 12 months
Pharmacokinetic measures - terminal half- life (t1/2)
Measure elimination half-life of CAN016, when administered
Measured: 12 months
Pharmacokinetic measures - Vd
Measure the volume of distribution after administration of CAN016.
Measured: 12 months
Pharmacokinetic measures - CL
Measure apparent total clearance(s) of CAN016 from blood after administration
Measured: 12 months
Immunogenicity of CAN016
Measure the incidence of anti-drug antibody (ADA) against CAN016
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start18 Jun 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canwell Biotech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, MD,PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664150
- Sponsor's protocol ID
- CW-301
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07664150
- Acronym / sponsor ID
- CW-301
- Conditions
- Patients With Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Canwell Biotech LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 24 Jun 2026 (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.
A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors
Detailed description
This is a Phase I/II, Open-Label, Non-Randomized, Multi-centre First-in-Human Study.
Phase I:
Accelerated Titration Designs and 3+3 escalation design for MTD and/or RP2D determination.
Phase II:
Once the RP2D is determined, the study will enroll patients into Phase II. Approximately 20~60 patients will be enrolled to evaluate the efficacy of CAN016 in HER2 expression or mutation advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer | Experimental | Drug: CAN016CAN016 |
| HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer | Experimental | Drug: CAN016CAN016 |
| HER2 expression or mutation advanced solid tumors | Experimental | Drug: CAN016CAN016 |
| For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted AD | Experimental | Drug: CAN016CAN016 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide informed consent voluntarily
- Male or female patients ≥18 years of age.
- Patients must have a histologically or cytologically confirmed diagnosis of recurrent or metastatic HER2 expression or mutation advanced solid tumor that has failed to or intolerable with standard treatment.
- At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate organ function with 7 days before registration
Key exclusion criteria (6 listed)
- Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.
- Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
- Patients have autologous transplantation within 3 months.
- Major surgery or had significant traumatic injury within 60 days prior to the first dose of the investigational product or has not recovered from major side effects.
- Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease.
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 |
|---|---|---|
| CAN016CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met. | Drug | HER2 expression or mutation advanced solid tumors, HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer, patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer |
| CAN016an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1. A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed. Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD), or withdrawal of consent, death, lost to follow-up (F/U), or other discontinuation criteria is met | Drug | For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted AD |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: 12 months
Incidence rate of dose limiting toxicities (DLT) in the first cycle (of 21 days) of each investigated dose levels.
Tumor objective response rate (ORR)
Time frame: 36 months
Tumor objective response rate (ORR) defined as the sum of complete response (CR) rate and partial response (PR) rate as best reported by Response Evaluation Criteria in Solid Tumors (RECIST1.1)
8 secondary outcomes
Safety and Tolerability
Time frame: 48 months
Pharmacokinetic measures - concentration time Area Under the Curves
Time frame: 12 months
Pharmacokinetic measures - Cmax
Time frame: 12 months
Pharmacokinetic measures - Tmax
Time frame: 12 months
Pharmacokinetic measures - terminal half- life (t1/2)
Time frame: 12 months
Pharmacokinetic measures - Vd
Time frame: 12 months
Pharmacokinetic measures - CL
Time frame: 12 months
Immunogenicity of CAN016
Time frame: 48 months
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 1 Jul 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.
Binghe Xu, MD,PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 CAN016 in people with Patients With Advanced Solid Tumors, run by Canwell Biotech Limited 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 10 inclusion and 6 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 1 Jul 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 Binghe Xu, MD,PhD (+86 010-67781331, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) (time frame: 12 months). 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 1 Jul 2026.