Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06332430

Intratumoral CAN2109 in Subjects With Solid Tumors

Led by Canwell Biotech Limited · Updated on 2024-12-19

27

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.

CONDITIONS

Official Title

Intratumoral CAN2109 in Subjects With Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide written informed consent and comply with study requirements
  • Male or female aged 18 years or older at screening
  • Metastatic or locally advanced solid tumor progressed on, refractory to, or lacking effective standard therapy; preferred tumors include skin carcinoma, melanoma, Merkel cell carcinoma, breast cancer, head and neck squamous cell carcinoma, sarcoma, cervical carcinoma, and colorectal cancer
  • ECOG Performance Status of 0-1
Not Eligible

You will not qualify if you...

  • Unresolved toxicities from prior therapy not resolved to CTCAE v5.0 Grade 0 or 1, except endocrinopathies, alopecia, and vitiligo
  • Treatment with systemic corticosteroids exceeding 10 mg/day prednisone or equivalent
  • Active infection requiring systemic therapy
  • Unstable or inadequate cardiac function including NYHA Class 3 or 4 heart failure, uncontrolled hypertension, recent acute coronary syndrome, important cardiac arrhythmia, or QTc interval > 480 ms
  • History of interstitial lung disease
  • History of coagulopathy causing uncontrolled bleeding or bleeding disorders
  • Participation in another investigational study within 30 days
  • Known psychiatric, substance abuse, or other disorders interfering with study cooperation
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
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Trial Site Locations

Total: 1 location

1

Sun Yat-Sen University Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China, 510535

Actively Recruiting

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Research Team

H

Herui Yao, MD

CONTACT

E

Erwei Song, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Intratumoral CAN2109 in Subjects With Solid Tumors | DecenTrialz