CW-301 FIH Study of CAN016

NCT07664150 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CW-301
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors

Conditions

Patients With Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Safety and Tolerability

  48 months

• Pharmacokinetic measures - concentration time Area Under the Curves

  12 months

• Pharmacokinetic measures - Cmax

  12 months

• Pharmacokinetic measures - Tmax

  12 months

• Pharmacokinetic measures - terminal half- life (t1/2)

  12 months

Study Arms (4)

patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer

EXPERIMENTAL

CAN016

Drug: CAN016

HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer

EXPERIMENTAL

CAN016

Drug: CAN016

HER2 expression or mutation advanced solid tumors

EXPERIMENTAL

CAN016

Drug: CAN016

For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted AD

EXPERIMENTAL

CAN016

Drug: CAN016

Interventions

CAN016 DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canwell Biotech Limited: lead

Study Sites (1)

Cancer Hospital Chinese Academy Of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Study Officials

• Binghe Xu, MD,PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu, MD,PhD

CONTACT

+86 010-67781331; xubinghe@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 24, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

CN (1)