CAN1012 Combined With PD-1 in Patients With Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: CAN1012

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.

• Study Type: Interventional
• Enrollment (Estimated): 71
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Herui Yao, MD; Phone Number: +86 020-34070412; Email: yaoherui@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510535
      • Recruiting
      • Sun Yat-sen University Sun Yat-sen Memorial Hospital
      • Contact: Herui Yao, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAN1012(0.01mg)+Toripalimab(240mg)	Drug: CAN1012; CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the approved dose of 240mg IV Q3W; Other Names: Toripalimab
Experimental: CAN1012(0.017mg)+Toripalimab(240mg)	Drug: CAN1012; CAN1012 IT injection every three weeks (Q3W), Toripalimab will be administered at the approved dose of 240mg IV Q3W; Other Names: Toripalimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Determine CAN1012 concentrations in plasma after IT administration.	1 year

Collaborators and Investigators

• Sponsor: Canwell Biotech Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CW-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No