Using CAN2109 to treat advanced solid tumors and lymphomas

A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN2109 in Subjects With Unresectable or Metastatic Advanced Solid Tumors.

This study is testing a new treatment called CAN2109 that is injected directly into tumors to see if it can help people with advanced solid tumors and lymphomas feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Canwell Biotech Limited (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06332430 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with metastatic or locally advanced solid tumors that have progressed despite standard therapies.

Not a fit: Patients with unresolved toxicities from prior therapies or those receiving high doses of systemic corticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors and lymphomas who have limited or no effective standard care.

How similar studies have performed: While this approach is novel, similar studies targeting intratumoral therapies have shown promise in other contexts, indicating potential for success.

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.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Herui Yao, MD

Conditions Solid Tumor; Lymphoma