CAN1012 Combined With PD-1 in Patients With Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A Phase Ib/IIa, Dose Escalation, Open-Label Study of Intratumoral CAN1012 Combined With PD-1 in Patients With Unresectable or Metastatic Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06410703
• Other study ID #: CW-103
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 30, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: Canwell Biotech Limited
• Contact: Herui Yao, MD
• Phone: +86 020-34070412
• Email: yaoherui[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 71
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-Sen University Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Canwell Biotech Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	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.	1 year
Secondary	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.
Secondary	To determine the Pharmacokinetics of CAN1012 Combined with PD-1	Determine CAN1012 concentrations in plasma after IT administration.	1 year