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RECRUITINGPHASE1

Intratumoral CAN2109 in Subjects With Solid Tumors

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

NCT06332430•Canwell Biotech Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (1)

Sun Yat-Sen University Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

May 28, 2024

Primary Completion Date

May 30, 2025

Completion Date

May 30, 2026

Last Updated

December 19, 2024

Enrollment

ESTIMATED participants

Conditions

Solid TumorLymphoma

Interventions

CAN2109

DRUG

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

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

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Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITINGPHASE2

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intratumoral CAN2109 in Subjects With Solid Tumors

Inclusion Criteria

Exclusion Criteria

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