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A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer

ConditionPancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAkeso

About this trial

This is an open-label, multi-center phase II clinical study consisting of two parts:

Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer.

Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be able and willing to provide written informed consent.

Have a life expectancy of at least 3 months.

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.

Disqualifiers

Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment.

There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.

There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.

Prior systemic therapy with either TGF-β inhibitors or anti-angiogenic agents.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK112

    Drug

    Following a predefined dose and date.

  • AK130

    Drug

    Following a predefined dose and date.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: AK112 in combination with AK130Experimental treatment 2 interventions
Group B: AK112Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of subjects with adverse events (AEs)

AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

Time frame
From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.
2

Objective Response Rate (ORR)

ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).

Time frame
Through study completion, an average of 2 years

Secondary outcomes

1

Disease control rate (DCR)

DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1).

Time frame
Through study completion, an average of 2 years
2

Duration of Response (DoR)

The time from first documented evidence of CR or PR until time of first documented disease progression.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
3

Time to response (TTR)

Time between date of start of treatment until first documented response (CR or PR).

Time frame
From date of randomization until the date of first documented response, assessed up to 24 months.
4

Progression Free Survival (PFS)

PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause.

Time frame
Through study completion, an average of 2 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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