Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients

NCT05636267 | Terminated Phase 1

• 1 other identifier: AK119-201
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (3)

• Number of subjects with dose limiting toxicities (DLTs)

  DLTs will be assessed during the first 3 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 3 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 90 days after the last dose of study drug

• Objective response rate (ORR)

  ORR is defined as the proportion of subjects with confirmed CR or confirmed PR.

  Up to 2 years

Secondary Outcomes (7)

• Progression-free survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Time to response (TTR)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (3)

AK119 + AK112

EXPERIMENTAL

Subjects will receive AK119 plus AK112 via intravenously (IV) Q3W, up to 2 years.

Drug: AK119; Drug: AK112

AK119 + AK112 + Pemetrexed + Carboplatin

EXPERIMENTAL

Subjects will receive AK119 and AK112 plus pemetrexed and carboplatin via intravenously (IV) Q3W, up to 4 cycles. Afterward, AK119 and AK112 plus pemetrexed will continue to be treated up to 2 years.

Drug: AK119; Drug: AK112; Drug: Pemetrexed; Drug: Carboplatin

AK112

EXPERIMENTAL

Subjects will receive AK112 monotherapy via intravenously (IV) Q3W, up to 2 years.

Drug: AK112

Interventions

AK119 DRUG

AK119 IV every 3 weeks.

AK119 + AK112; AK119 + AK112 + Pemetrexed + Carboplatin

AK112 DRUG

AK112 IV every 3 weeks.

AK112; AK119 + AK112; AK119 + AK112 + Pemetrexed + Carboplatin

Pemetrexed DRUG

Pemetrexed IV every 3 weeks.

AK119 + AK112 + Pemetrexed + Carboplatin

Carboplatin DRUG

Carboplatin IV every 3 weeks.

AK119 + AK112 + Pemetrexed + Carboplatin

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 to understand and voluntarily sign the written informed consent, which must be signed before the designated research procedure.
• Age ≥ 18 and ≤ 75, male or female.
• Local advanced or metastatic non-squamous NSCLC confirmed by histology or cytology according to eighth edition of the TNM classification for lung cancer.
• EGFR activating mutation confirmed by tumor histology, cytology or hematology.
• Failed to previous EGFR-TKI treatment.
• ECOG performance status 0 to1.
• Life expectancy ≥3 months.
• At least one measurable lesion according to RECIST v1.1.
• Adequate organ function.

You may not qualify if:

• Histological or cytological pathology confirmed the presence of small cell carcinoma or squamous cell carcinoma.
• Have suffered from the second primary active malignant tumor in the past 3 years.
• There are other driving gene mutations that can obtain effective treatment.
• Receipt of the following treatments or procedures: immunotherapy, including immunocheckpoint inhibitors, immunocheckpoint agonists, immunocellular therapy, and any other treatment targeting tumor immune mechanism; systematic chemotherapy in the advanced stage (IIIB-IV); anti-angiogenesis drugs, except for small molecule anti-angiogenesis drugs with drug withdrawal more than 4 weeks; extensive radiotherapy within 4 weeks; EGFR-TKIs within 2 weeks.
• Symptomatic central nervous system metastases.
• The toxicity of previous anti-tumor therapy has not been alleviated.
• Uncontrolled massive ascites, pleural effusion or pericardial effusion.
• Active autoimmune diseases in the past 2 years.
• History of interstitial lung disease or noninfectious pneumonitis.
• Suffering from clinically significant cardiovascular or cerebrovascular diseases.
• History of severe bleeding tendency or coagulation dysfunction.
• History of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism in the past 3 months.
• Serious infection in the past 4 weeks.
• Acute exacerbation of chronic obstructive pulmonary disease or asthma in the past 4 weeks.
• History of human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, China

Location

MeSH Terms

Interventions

Pemetrexed; Carboplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Yilong Wu, PhD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 5, 2022
• Study Start: February 10, 2023
• Primary Completion: February 24, 2025
• Study Completion: April 15, 2025
• Last Updated: March 9, 2026

Record last verified: 2023-03

Locations

CN (1)