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AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

ConditionColorectal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent.

Age ≥ 18 years and ≤ 75 years.

ECOG status of 0 or 1.

Estimated survival ≥ 3 months.

Disqualifiers

Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.

Participating in other interventional study within 4 weeks prior to the first study drug administration.

Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration.

Current presence of uncontrolled combined disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK112

    Drug

    iv, q2w

  • Oxaliplatin

    Drug

    iv, q2w

  • Irinotecan

    Drug

    iv, q2w

  • Leucovorin and 5-FU

    Drug

    iv, q2w

  • Bevacizumab

    Drug

    iv, q2w

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: AK112 in combination with FOLFOXIRIExperimental treatment 4 interventions
Group B: Bevacizumab in combination with FOLFOXIRIActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) assessed by blinded independent central review (BICR)

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).

Time frame
Up to approximately 3 years

Secondary outcomes

1

Overall survival (OS)

OS is defined as the time from randomization to death due to any cause.

Time frame
Up to approximately 5 years
2

Progression-free survival (PFS) assessed by investigator

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).

Time frame
Up to approximately 3 years
3

Objective Response Rate (ORR)

ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria.

Time frame
Up to approximately 3 years
4

Duration of Response (DoR)

DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first.

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

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

Akeso

Lead sponsor

Source ClinicalTrials.gov
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