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Trial Title:
CAN1012 Combined With PD-1 in Patients With Solid Tumors
NCT ID:
NCT06410703
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CAN1012
Description:
CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the
approved dose of 240mg IV Q3W
Arm group label:
CAN1012(0.017mg)+Toripalimab(240mg)
Arm group label:
CAN1012(0.01mg)+Toripalimab(240mg)
Other name:
Toripalimab
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.
Criteria for 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. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Sun Yat-Sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510535
Country:
China
Status:
Recruiting
Contact:
Last name:
Herui Yao, Professor
Start date:
June 27, 2024
Completion date:
May 30, 2026
Lead sponsor:
Agency:
Canwell Biotech Limited
Agency class:
Industry
Source:
Canwell Biotech Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06410703
