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This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs. The phase II portion consists of a part A dose-escalation stage and a part B dose-expansion stage. The phase III study will be initiated following discussions with National Medical Products Administration (NMPA) regarding the phase III protocol, based on accumulated data from phase II including safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).
Phase II Part A: To evaluate the safety and tolerability of VRT106 in combination with camrelizumab and apatinib at different dose levels in patients with HCC who have failed prior ICIs, and to determine the recommended phase II dose (RP2D).
Phase II Part B: To evaluate the progression-free survival (PFS) of VRT106 in combination with camrelizumab and apatinib at the RP2D versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.
Phase III: To evaluate the overall survival (OS) of VRT106 in combination with camrelizumab and apatinib versus investigator's choice of standard of care in patients with advanced HCC who have failed prior ICIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRT106 Monotherapy | Experimental | VRT106 |
|
| VRT106 Combination | Experimental | VRT106 in combination with camrelizumab and apatinib |
|
| Standard of Care | Active Comparator | Investigator's Choice of Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRT106 | Drug | VRT106,Intravenous infusion |
| |
| VRT106 in combination with camrelizumab and apatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicities | Safety assessments included: AEs, SAEs, physical examination, vital signs, ECOG PS, 12-lead ECG, echocardiography, and clinical laboratory evaluations. | Dose-limiting toxicity (DLT) will be assessed within 56 days following the first administration of VRT106. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. | About 2 years |
| Overall survival | Time from initial administration to death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Peng | Contact | 020-85252621 | pliang@mail.sysu.edu.cn | |
| Chan Xie | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Liang Peng | Third Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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| Drug |
VRT106: Intravenous infusion Camrelizumab: Intravenous infusion Apatinib: Oral administration |
|
| Investigator's Choice of Standard of Care | Drug | At the investigator's discretion |
|
| About 2 years |