CAN1012

Chen Rongchu

Lu Zhaoliang, Doctor

Song Erwei, Doctor

Yao Herui, Doctor

To evaluate CAN1012 when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy.

Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors

A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN1012 in Subjects With Unresectable or Metastatic Advanced Solid Tumors

Safety as determined by assessment of dose limiting toxicities per protocol of CAN1012 with cancers.

Tolerability as determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN 1012 with cancers.

To determine a recommended phase 2 dose of CAN1012 for further development by evaluating number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0)

Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE 5.0).

Maximum observed plasma and tumor concentration of CAN1012 after IT administration.

Time to reach maximum plasma and tumor concentration of CAN1012 after IT administration.

Changes in tumor size using computed tomography (CT) scan or magnetic resonance imaging (MRI) scan assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Canwell Biotech Limited

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

Herui Yao, MD

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.

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.

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

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.

Monitor a tumor response to the combination therapy according to RECIST 1.1 or iRECIST 1.1 as appropriate.

Determine CAN1012 concentrations in plasma after IT administration.

Rongchu Chen

Brendan D Curti, MD

To evaluate CAN1012(Selective TLR7 agonist) when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy.

This is a Phase 1, open-label, first-in-human, single-arm, multicenter, dose escalation study of IT CAN1012 in subjects with advanced solid tumors who are not candidates for standard therapy.

Subjects will be enrolled in cohorts of 3 at each dose level using a 3+3 dose escalation design Approach.

Safety and tolerability as determined by assessment of dose limiting toxicities and the maximum tolerated dose or maximal assessed dose per protocol of CAN1012 with cancers.

To determine a recommended phase 2 dose of CAN1012 for further development by evaluating number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE v5.0).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors	NCT05580991	Solid Tumor	CAN1012	18 Years -	Canwell Biotech Limited
CAN1012 Combined With PD-1 in Patients With Solid Tumors	NCT06410703	Advanced Solid ...	CAN1012	18 Years -	Canwell Biotech Limited
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors	NCT04987112	Solid Tumor Cancer Metastat...	CAN1012	18 Years - 80 Years	CanWell Pharma Inc.
CAN1012 Combined With PD-1 in Patients With Solid Tumors	NCT06410703	Advanced Solid ...	CAN1012	18 Years -	Canwell Biotech Limited

Spots Global Cancer Trial Database for can1012

Every month we try and update this database with for can1012 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for can1012

Every month we try and update this database with for can1012 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for can1012 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.