CAN1012 Combined With PD-1 in Patients With Solid Tumors

NCT06410703 | Recruiting Phase 1

• 1 other identifier: CW-103
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• To determine the Pharmacokinetics of CAN1012 Combined with PD-1

  1 year

Study Arms (2)

CAN1012(0.01mg)+Toripalimab(240mg)

EXPERIMENTAL

CAN1012(0.01mg)+Toripalimab(240mg)

Drug: CAN1012

CAN1012(0.017mg)+Toripalimab(240mg)

EXPERIMENTAL

CAN1012(0.017mg)+Toripalimab(240mg)

Drug: CAN1012

Interventions

CAN1012 DRUG

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

Also known as: Toripalimab

CAN1012(0.017mg)+Toripalimab(240mg); CAN1012(0.01mg)+Toripalimab(240mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and willing to comply with the study's requirements.
• Male or female age ≥ 18 years at screening.
• 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.
• 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
• Performance status of 0-1 on the ECOG Performance Scale.

You may not qualify if:

• 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.
• Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
• Has an active infection requiring systemic therapy.
• Unstable/inadequate cardiac function defined as follows:
• New York Heart Association Class 3 or 4 congestive heart failure
• uncontrolled hypertension
• acute coronary syndrome within 6 months
• clinical important cardiac arrhythmia
• mean corrected QT (QTc) interval corrected for heart rate \>450msec（male），\>470msec（female）.
• A history of interstitial lung disease.
• A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
• Participated in a clinical study of an investigational agent within 30 days of screening.
• 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.
• Is pregnant or breastfeeding.

Sponsors & Collaborators

• Canwell Biotech Limited: lead

Study Sites (1)

Sun Yat-Sen University Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510535, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Central Study Contacts

Herui Yao, MD

CONTACT

+86 020-34070412; yaoherui@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 13, 2024
• Study Start: June 27, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-05

Locations

CN (1)