Using CAN2109 to treat advanced solid tumors and lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, open-label study evaluates the safety and efficacy of intratumoral CAN2109 in patients with unstable or metastatic advanced solid tumors or lymphomas. The study involves a dose escalation approach to determine the optimal dosage while monitoring pharmacokinetics and pharmacodynamics effects on the immune system and tumor markers. Participants will receive CAN2109 directly into their tumors, and data will be collected to assess both local and systemic responses to the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-Sen University Sun Yat-Sen Memorial Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Herui Yao, MD
• Email: yaoherui@mail.sysu.edu.cn
• Phone: +86 020-34070412

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.