CW-301 FIH Study of CAN016

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

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Advanced Solid Tumors
• Intervention / Treatment: Drug: CAN016; Drug: CAN016

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Binghe Xu, MD,PhD; Phone Number: +86 010-67781331; Email: xubinghe@medmail.com.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy Of Medical Sciences
      • Contact: Binghe Xu, MD,PhD; Phone Number: +86 010-67781331; Email: xubinghe@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provide informed consent voluntarily 2. Male or female patients ≥18 years of age. 3. 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.

1. 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;

2. 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.

   4. At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

   5. Adequate organ function with 7 days before registration 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 7. LVEF ≥50% by either echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before registration.

   8. Life expectancy of ≥3 months. Exclusion Criteria

   1. 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.
   2. 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.
   3. Patients have autologous transplantation within 3 months.
   4. 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.
   5. Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease.
   6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer; CAN016	Drug: CAN016; 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.; Drug: CAN016; 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
Experimental: HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer; CAN016	Drug: CAN016; 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.; Drug: CAN016; 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
Experimental: HER2 expression or mutation advanced solid tumors; CAN016	Drug: CAN016; 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.; Drug: CAN016; 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
Experimental: For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted AD; CAN016	Drug: CAN016; 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.; Drug: CAN016; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicities (DLT)	Incidence rate of dose limiting toxicities (DLT) in the first cycle (of 21 days) of each investigated dose levels.	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)	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 months
Pharmacokinetic measures - concentration time Area Under the Curves	Measure the variation of CAN016 concentration in blood as a function time	12 months
Pharmacokinetic measures - Cmax	Measure the maximum (peak) blood concentration(s) of CAN016	12 months
Pharmacokinetic measures - Tmax	Measure of time to reach maximum (peak) blood concentration(s) following administration of CAN016	12 months
Pharmacokinetic measures - terminal half- life (t1/2)	Measure elimination half-life of CAN016, when administered	12 months
Pharmacokinetic measures - Vd	Measure the volume of distribution after administration of CAN016.	12 months
Pharmacokinetic measures - CL	Measure apparent total clearance(s) of CAN016 from blood after administration	12 months
Immunogenicity of CAN016	Measure the incidence of anti-drug antibody (ADA) against CAN016	48 months

Collaborators and Investigators

• Sponsor: Canwell Biotech Limited
• Investigators: Principal Investigator: Binghe Xu, MD,PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CW-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No