CAN1012 Combined With PD-1 in Patients With Solid Tumors

NCT ID: NCT06410703

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2026-05-30

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAN1012(0.01mg)+Toripalimab(240mg)

CAN1012(0.01mg)+Toripalimab(240mg)

Group Type: EXPERIMENTAL

CAN1012

Intervention Type: DRUG

CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the approved dose of 240mg IV Q3W

CAN1012(0.017mg)+Toripalimab(240mg)

CAN1012(0.017mg)+Toripalimab(240mg)

Group Type: EXPERIMENTAL

CAN1012

Intervention Type: DRUG

CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the approved dose of 240mg IV Q3W

Interventions

CAN1012

CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the approved dose of 240mg IV Q3W

Intervention Type: DRUG

Other Intervention Names

Toripalimab

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canwell Biotech Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-Sen University Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Herui Yao, MD

Role: CONTACT

yaoherui@mail.sysu.edu.cn

+86 020-34070412

Facility Contacts

Herui Yao, Professor

Role: primary

Other Identifiers

CW-103

Identifier Type: -

Identifier Source: org_study_id