Intratumoral CAN2109 in Subjects With Solid Tumors

NCT ID: NCT06332430

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2026-05-30

Brief 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.

Conditions

Solid Tumor; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAN2109

CAN2109 IT injection every three weeks (Q3W)

Group Type: EXPERIMENTAL

CAN2109

Intervention Type: DRUG

CAN2109 IT injection (once every 3 weeks)

Interventions

CAN2109

CAN2109 IT injection (once every 3 weeks)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canwell Biotech Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-Sen University Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Herui Yao, MD

Role: CONTACT

Phone: +86 020-34070412

Email: yaoherui@mail.sysu.edu.cn

Erwei Song, MD

Role: CONTACT

Phone: +86 020 81332507

Email: songew@mail.sysu.edu.cn

Facility Contacts

Herui Yao, Professor

Role: primary

Other Identifiers

CW-202

Identifier Type: -

Identifier Source: org_study_id