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Trial Title: Intratumoral CAN2109 in Subjects With Solid Tumors

NCT ID: NCT06332430

Condition: Solid Tumor
Lymphoma

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: CAN2109
Description: CAN2109 IT injection (once every 3 weeks)
Arm group label: CAN2109

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

Detailed description: The scope of the study is to evaluate the safety of CAN2109 in humans, explore its safety, efficacy and collect data on the pharmacokinetics, as well as on the pharmacodynamic effect of the drug on the immune system locally and systemically, and on tumor markers.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Sun Yat-Sen University Sun Yat-Sen Memorial Hospital

Address:
City: Guangzhou
Zip: 510535
Country: China

Status: Recruiting

Contact:
Last name: Herui Yao, Professor

Start date: May 28, 2024

Completion date: May 30, 2026

Lead sponsor:
Agency: Canwell Biotech Limited
Agency class: Industry

Source: Canwell Biotech Limited

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06332430

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