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CW-301 FIH Study of CAN016

NCT07664150 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Canwell Biotech Limited

    lead INDUSTRY

Principal Investigators

  • Binghe Xu, MD,PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-18
Primary Completion
2028-12-30
Completion
2029-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07664150 on ClinicalTrials.gov