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

An Open Label, Multicenter, Phase Ib/II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer

There're 2 parts in this interventional study:

1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK130 in combination with AK112 therapy for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced biliary tract cancer (BTC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial.
2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination with AK130 therapy or monotherapy in the treatment of advanced BTC.

Study Overview

• Status: Recruiting
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Drug: AK112; Drug: AK130

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Wenting Li; Phone Number: 18116403289; Email: wenting01.li@akesobio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Contact: Haitao Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be able and willing to provide written informed consent.
2. Have a life expectancy of at least 3 months.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Subjects with histologically and/or cytologically confirmed advanced or metastatic biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma; excluding ampullary carcinoma), who have experienced treatment failure following prior first-line systemic therapy.
5. According to RECIST v1.1, there is at least one untreatable measurable lesion, or a measurable lesion with clear imaging progression after local treatment, suitable for repeated and accurate measurement.
6. Has adequate organ function.
7. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
8. Able to to comply with all requirements of study participation (including all study procedures).

Exclusion Criteria:

1. Except for BTC, the subjects had other malignant tumors within the 3 years prior to enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ.
2. There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
3. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
4. Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
5. There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
6. History of severe bleeding tendency or coagulation dysfunction.
7. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
8. Any arterial or severe venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to the first administration of medication.
9. Pregnant or lactating female subject.
10. Any prior or concurrent disease, treatment, or laboratory test abnormality that may confuse study results, affect subjects' full participation in the study, or may not be in their best interest to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK112 in combination with AK130	Drug: AK112; Following a predefined dose and date.; Drug: AK130; Following a predefined dose and date.
Experimental: AK112	Drug: AK112; Following a predefined dose and date.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with dose limiting toxicities (DLTs)	DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.	During the first three weeks.
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.	From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.
Objective Response Rate (ORR) (Phase II)	ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).	Through study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) (Phase Ib)	ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).	Through study completion, an average of 2 years.
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).	Through study completion, an average of 2 years
Duration of Response (DoR)	The time from first documented evidence of CR or PR until time of first documented disease progression.	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
Time to response (TTR)	Time between date of start of treatment until first documented response (CR or PR).	From date of randomization until the date of first documented response, assessed up to 24 months
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.	Through study completion, an average of 2 years.
Overall survival (OS)	OS is defined as the time from first dose until death due to any cause	Through study completion, an average of 2 years.

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: AK130-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No