Lymphoma, Solid Tumor
Conditions
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.
Interventions
DRUGCAN2109
CAN2109 IT injection (once every 3 weeks)
Sponsors
Canwell Biotech Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 12 months | determined by assessment of dose limiting toxicities per protocol of CAN2109 with cancers. |
| Recommended Phase 2 Dose (RP2D) | 12 months | 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). |
| tolerability | 12 months | determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN2109 with cancers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the efficacy of CAN2109 | 12 months | Proportion of patients experiencing a tumor response or a stable disease according to RECIST 1.1 or iRECIST 1.1 as appropriate. |
| To evaluate the pharmacodynamics of CAN2109 | 12 months | Maximum observed plasma and tumor concentration of CAN2109 after IT administration. |
Countries
China
Contacts
Primary ContactHerui Yao, MD
Backup ContactErwei Song, MD
Outcome results
None listed