A Study of AK104 in Combination With Chiauranib in Patients With Extensive Stage Small Cell Lung Cancer

NCT05505825 | Completed Phase 1

• 1 other identifier: AK104-212
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 7

Brief Summary

A Phase Ib/II open label,international multicentre study to evaluate the efficacy and safety of anti-PD-1 and CTLA-4 bispecific antibody AK104 in combination with Chiauranib in Patients with Extensive Stage Small Cell Lung Cancer Who Failed First-line Platinum-based Chemotherapy in Combination with PD1/PDL1 Inhibitors

Conditions

SCLC,Extensive Stage

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

  Up to approximately 2 years

• Incidence and severity of adverse events(AEs)

  Incidence and severity of AEs is aim to evaluate the safety of AK104 in combination with Chiauranib.

  Up to approximately 2 years

Secondary Outcomes (7)

• Disease control rate (DCR)

  Up to approximately 2 years

• duration of response (DoR)

  Up to approximately 2 years

• time to response (TTR)

  Up to approximately 2 years

• progression-free survival (PFS)

  Up to approximately 2 years

• overall survival (OS)

  Up to approximately 2 years

Other Outcomes (2)

• alpha thalassemia/mental retardation X-linked(ATRX) gene mutation status

  Up to approximately 2 years

• SCLC subtype

  Up to approximately 2 years

Study Arms (1)

AK104 once every 3 weeks and Chiauranib once a day

EXPERIMENTAL

Subjects receive AK104 once every 3 weeks plus Chiauranib once a day until intolerable toxicity, no more clinical benefit as judged by the investigator, or completion of 24 months of treatment, or meeting other criteria for termination of treatment in the protocol, whichever occurs first.

Drug: AK104 IV infusion；Chiauranib oral

Interventions

AK104 IV infusion；Chiauranib oral DRUG

AK104 IV infusion once every 3 weeks；Chiauranib once a day oral

AK104 once every 3 weeks and Chiauranib once a day

Eligibility Criteria

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

You may qualify if:

• The subject must sign the written informed consent form (ICF) voluntarily.
• Aged ≥ 18 to ≤ 75 years.
• Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1.
• Life expectancy≥ 3 months.
• Histologically or cytologically confirmed ES-SCLC according to the Veterans Administration Lung Study Group(VALG) stage.
• Phase Ib and II: Subjects with ES-SCLC who have failed prior first-line platinum-based chemotherapy in combination with PD1/PDL1 inhibitors will be enrolled.
• At least 1 measurable lesion per RECIST v1.1, which is applicable for repeated accurate measurement. Brain metastatic lesions are not considered target lesions.
• Adequate organ function.
• Women of childbearing potential must have a negative urine or serum pregnancy test
• If a nonsterile male subject has sexual intercourse with a female partner of childbearing potential, he must use an effective method of contraception from the start of screening until Day 120 after the last dose; it should be discussed with the Investigator whether contraception should be discontinued after this time point.
• Subjects must be willing and able to comply with the scheduled visits, treatment regimens, laboratory tests, and other requirements in the study.

You may not qualify if:

• Malignancies other than SCLC within 3 years prior to enrollment. However, subjects with other malignancies that have been cured are eligible.
• Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study.
• Subjects whose imaging at screening shows that the tumor encircles important blood vessels or has significant necrosis and cavitation, and the subjects'participation is associated with a risk of hemorrhage.
• Tumor invasion of surrounding vital organs and blood vessels.
• Subjects who had active autoimmune disease that required systemic treatment in the past two years.
• Subjects with prior history of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy or with non-infectious pneumonitis at present.
• Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression.
• Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require drainage.
• Subjects who cannot swallow pills, and who have malabsorption syndrome, or any condition affecting gastrointestinal absorption. Subjects with active or prior history of definite inflammatory bowel disease.
• Subjects with a history of immunodeficiency; a positive human immunodeficiency virus (HIV) antibody test; and current long-term use of systemic corticosteroids or other immunosuppressants.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Subjects who had major surgical procedure or serious trauma within 30 days prior to the first dose, or a major scheduled surgery within 30 days after the first dose; subjects who had minor local surgery within 3 days prior to the first dose.

Sponsors & Collaborators

• Akeso: lead
• Chipscreen Biosciences, Ltd.: collaborator

Study Sites (7)

Westmead Hospital

Westmead, New South Wales, Australia

Location

Icon Cancer Centre

South Brisbane, Queensland, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, Australia

Location

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Location

Sunshine Hospital

St Albans, Victoria, Australia

Location

Jilin Province Cancer Hospital

Changchun, Jilin, 130000, China

Location

Study Officials

• Ying Cheng, Professor

  Jilin Province Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: August 26, 2022
• Primary Completion: July 19, 2024
• Study Completion: July 31, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); CN (1)