Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Chemotherapy in Patients With ES-SCLC

NCT05116007 | Completed Phase 1

• 1 other identifier: AK112-103
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Phase Ib open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with chemotherapy in patients with ES-SCLC.

Conditions

SCLC, Extensive Stage

Outcome Measures

Primary Outcomes (2)

• Incidence of Grade 3 or higher adverse events (AEs)

  Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0

  Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years

• Objective Response Rate (ORR)

  ORR is proportion of subjects with complete response(CR) or partial response(PR). Tumor responses will be evaluated according to RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders.

  Interval between the date of enrollment and the date of death from any cause, up to a maximum of 18 months.

Secondary Outcomes (3)

• Disease control rate (DCR)

  Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years

• Progression free survival (PFS)

  Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 24 months.

• Overall survival (OS)

  Interval between the date of enrollment and the date of death from any cause, up to a maximum of 24 months.

Study Arms (1)

Experimental

EXPERIMENTAL

Subjects receive AK112 plus Etoposide and Carboplatin every 3- week cycle (Q3W) for 4 cycles followed by AK112 until progression.

Drug: AK112; Drug: Etoposide; Drug: Carboplatin

Interventions

AK112 DRUG

IV infusion

Experimental

Etoposide DRUG

Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

Experimental

Carboplatin DRUG

Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4)

Experimental

Eligibility Criteria

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

You may qualify if:

• to 75 years old (at the time of inform consent obtained).
• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system).
• Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy.
• Have a life expectancy of at least 3 months.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator
• Has adequate organ function
• All female and male 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.

You may not qualify if:

• Undergone major surgery within 30 days prior to the first dose of study treatment
• History of prior malignancy except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• Active central nervous system (CNS) metastases
• History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
• Active infection requiring systemic therapy
• Active Hepatitis B or Hepatitis C
• History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment;
• Pregnant or lactating women

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Shun Lu

Shanghai, Shanghai Municipality, 021, China

Location

MeSH Terms

Interventions

Etoposide; Carboplatin

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes

Study Officials

• Shun Lu, Professor

  Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, P. R. China

  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: September 21, 2021
• First Posted: November 10, 2021
• Study Start: March 29, 2021
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

CN (1)