Intratumoral CAN2109 in Subjects With Solid Tumors or Lymphomas

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332430
• Other study ID #: CW-202
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 30, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: March 2024
• Source: Canwell Biotech Limited
• Contact: Herui Yao, MD
• Phone: +86 020-34070412
• Email: yaoherui[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumor

Intervention

Drug:
• CAN2109
CAN2109 IT injection (once every 3 weeks)

Locations

Country	Name	City	State
China	Sun Yat-Sen University Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Canwell Biotech Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Safety and tolerability as determined by assessment of dose limiting toxicities and the maximum tolerated dose or maximal assessed dose per protocol of CAN2109 with cancers.	12 months
Primary	Recommended Phase 2 Dose (RP2D)	To determine a recommended phase 2 dose of CAN21909 for further development by evaluating number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).	12 months
Secondary	To determine the efficacy of CAN2109	Proportion of patients experiencing a tumor response or a stable disease according to RECIST 1.1 or iRECIST 1.1 as appropriate.	12 months
Secondary	To evaluate the pharmacodynamics of CAN2109	Maximum observed plasma and tumor concentration of CAN2109 after IT administration.	12 months