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A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases

ConditionColorectal Cancer With Hepatic Metastases
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent

Age≥18 years and ≤ 75 years

Histologically or cytologically confirmed unresectable colorectal cancer with liver metastases; adenocarcinoma type

Disease progression after first- or second-line standard therapy

Disqualifiers

Histologically or cytologically confirmed non-adenocarcinoma or mixed-type tumors with adenocarcinoma component ≤70%

Known dMMR or MSI-H

Known RAS or BRAF mutations

Participation in another clinical trial

Trial design

Design model

Sequential

Treatments tested in this trial

  • VG2025

    Biological/Vaccine

    Recommended Phase II Dose, Intratumoral Injection, Q4W

  • AK112

    Drug

    20mg/kg, ivgtt, Q2W

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Cohort A (VG2025+AK112)Experimental treatment 2 interventions
Group B: Cohort B (AK112)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants experiencing dose-limiting toxicities (DLTs)

Number of participants who meet the criteria of dose-limiting toxicities (DLTs) in DLT observation period

Time frame
From Day 1 to Day 28 after the first tumour vaccine was administrated in safety run-in cohorts
2

Number of participants with adverse events (AEs) and severity

Number of participants experiencing adverse events (AEs) and severity, graded according to CTCAE v5.0

Time frame
From ICF up to 30 days after last study treatment
3

Objective Response Rate (ORR)

Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1

Time frame
Time Frame: Up to 2 years

Secondary outcomes

1

Progression free survival (PFS)

Time from the date of enrollment until the first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by RECIST version 1.1

Time frame
Up to 2 years
2

Disease control rate (DCR)

Proportion of participants with complete response (CR), partial response (PR), or stable disease (SD), as assessed by RECIST version 1.1

Time frame
Up to 2 years
3

Duration of response (DoR)

Time from the first documentation of objective response to the first documented disease progression as assessed by RECIST version 1.1 or death due to any cause, whichever occurs first

Time frame
Up to 2 years
4

Time to response (TTR)

Time from the start of the treatment to the first objective tumor response observed for patients who achieved complete response (CR) or partial response (PR), as assessed by RECIST version 1.1

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Shanghai Virogin Biotech Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: