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

NCT06938321 | Recruiting Phase 1

• 1 other identifier: AK130-201
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

There're 2 parts in this interventional study:

1. 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. 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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Objective Response Rate (ORR) (Phase Ib)

  Through study completion, an average of 2 years.

• Disease control rate (DCR)

  Through study completion, an average of 2 years

• Duration of Response (DoR)

  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)

  From date of randomization until the date of first documented response, assessed up to 24 months

• Progression Free Survival (PFS)

  Through study completion, an average of 2 years.

Study Arms (2)

AK112 in combination with AK130

EXPERIMENTAL

Drug: AK112; Drug: AK130

AK112

EXPERIMENTAL

Drug: AK112

Interventions

AK112 DRUG

Following a predefined dose and date.

AK112; AK112 in combination with AK130

AK130 DRUG

Following a predefined dose and date.

AK112 in combination with AK130

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• 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.
• Has adequate organ function.
• 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.
• Able to to comply with all requirements of study participation (including all study procedures).

You may not qualify if:

• 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.
• 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 administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
• There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
• History of severe bleeding tendency or coagulation dysfunction.
• Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
• 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.
• Pregnant or lactating female subject.
• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Wenting Li

CONTACT

18116403289; wenting01.li@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 22, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)