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Clinical Trials in China / NCT06332430
Recruiting Phase 1

Intratumoral CAN2109 in Subjects With Solid Tumors

NCT06332430 · tracked via the Priya Life Science China tracker
Sponsor
Canwell Biotech Limited
Phase
Phase 1
Started
2024-05-28
Last updated
2024-12-19

Condition(s) studied

Solid TumorLymphoma

Investigational drug(s) / intervention(s)

CAN2109

CAN2109: CAN2109 IT injection (once every 3 weeks)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Able and willing to provide written informed consent and willing to comply with the study's requirements. 2. Male or female age ≥ 18 years at screening. 3. Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy. Preferred tumor types include the following: a. Carcinoma of skin, melanoma, Merkel cell carcinoma (MCC), breast cancer, head and neck squamous cell carcinoma (HNSCC), sarcoma, cervical carcinoma, and colorectal cancer 4. Performance status of 0-1 on the ECOG Performance Scale. Exclusion Criteria: 1. Unresolved toxicities from prior therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0) Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo. 2. Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent. 3. Has an active infection requiring systemic therapy. 4. Unstable/inadequate cardiac function defined as follows: 1. New York Heart Association Class 3 or 4 congestive heart failure 2. uncontrolled hypertension 3. acute coronary syndrome within 6 months 4. clinical important cardiac arrhythmia 5. mean corrected QT (QTc) interval corrected for heart rate \> 480 ms. 5. A history of interstitial lung disease. 6. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders. 7. Participated in a clinical study of an investigational agent within 30 days of screening. 8. Has known psychiatric, substance abuse, or other disorders that would interfere with cooperation with the requirements of the study in the opinion of the investigator. 9. Is pregnant or breastfeeding.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-Sen University Sun Yat-Sen Memorial Hospital Guangzhou Guangdong Recruiting

More Canwell Biotech Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06332430 on ClinicalTrials.gov ↗ ← All trials in China