Intratumoral CAN2109 in Subjects With Solid Tumors

NCT06332430 | Recruiting Phase 1

• 1 other identifier: CW-202
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor; Lymphoma

Outcome Measures

Primary Outcomes (3)

• Safety

  determined by assessment of dose limiting toxicities per protocol of CAN2109 with cancers.

  12 months

• 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

• tolerability

  determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN2109 with cancers.

  12 months

Secondary Outcomes (2)

• To determine the efficacy of CAN2109

  12 months

• To evaluate the pharmacodynamics of CAN2109

  12 months

Study Arms (1)

CAN2109

EXPERIMENTAL

CAN2109 IT injection every three weeks (Q3W)

Drug: CAN2109

Interventions

CAN2109 DRUG

CAN2109 IT injection (once every 3 weeks)

CAN2109

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and willing to comply with the study's requirements.
• Male or female age ≥ 18 years at screening.
• 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
• Performance status of 0-1 on the ECOG Performance Scale.

You may not qualify if:

• 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.
• Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
• Has an active infection requiring systemic therapy.
• Unstable/inadequate cardiac function defined as follows:
• New York Heart Association Class 3 or 4 congestive heart failure
• uncontrolled hypertension
• acute coronary syndrome within 6 months
• clinical important cardiac arrhythmia
• mean corrected QT (QTc) interval corrected for heart rate \> 480 ms.
• A history of interstitial lung disease.
• A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
• Participated in a clinical study of an investigational agent within 30 days of screening.
• 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.
• Is pregnant or breastfeeding.

Sponsors & Collaborators

• Canwell Biotech Limited: lead

Study Sites (1)

Sun Yat-Sen University Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510535, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Herui Yao, MD

CONTACT

+86 020-34070412; yaoherui@mail.sysu.edu.cn

Erwei Song, MD

CONTACT

+86 020 81332507; songew@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: May 28, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CN (1)