Advanced Solid Tumor
Conditions
Brief summary
This is a Phase Ia/IIb, open-label, first-in-human, multicenter, single-arm, dose escalation study of intratumoral CAN1012 combined with PD-1 in patients with Unresectable or Metastatic Advanced Solid Tumors who have exhausted options for standard of care therapy.
Detailed description
The scope of the study is to evaluate the safety of the combination therapy of CAN1012 and PD-1 in human, study its efficacy and pharmacokinetics profiles, as well as explore its pharmacodynamic effects and biomarkers.
Interventions
DRUGCAN1012
CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the approved dose of 240mg IV Q3W
Sponsors
Canwell Biotech Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
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. Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. 4. 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: Carcinoma of skin, melanoma, Merkel cell carcinoma (MCC), breast cancer, head and neck squamous cell carcinoma (HNSCC), sarcoma, cervical carcinoma, and colorectal cancer 5. 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 \>450msec（male），\>470msec（female）. 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 and tolerability | 1 year | Safety and tolerability as determined by assessing dose limiting toxicities, the maximum tolerated dose or maximal assessed dose per protocol in combination with toripalimab (anti-PD-1) with patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the MTD and or RP2D of CAN1012 Combined with PD-1 | Monitor a tumor response to the combination therapy according to RECIST 1.1 or iRECIST 1.1 as appropriate. | Monitor a tumor response to the combination therapy according to RECIST 1.1 or iRECIST 1.1 as appropriate. |
| To determine the Pharmacokinetics of CAN1012 Combined with PD-1 | 1 year | Determine CAN1012 concentrations in plasma after IT administration. |
Countries
China
Contacts
Primary ContactHerui Yao, MD
Outcome results
None listed