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

Sponsor

Akeso (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05116007

Collaborator

(none)

100

Enrollment

Location

Arm

20.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SCLC, Extensive Stage	Drug: AK112 Drug: Etoposide Drug: Carboplatin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase Ib Clinical Study of Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Etoposide and Carboplatin for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Actual Study Start Date :

Mar 29, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Subjects receive AK112 plus Etoposide and Carboplatin every 3- week cycle (Q3W) for 4 cycles followed by AK112 until progression.	Drug: AK112 IV infusion Drug: Etoposide 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). Drug: Carboplatin 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)

Arm

Intervention/Treatment

Experimental: Experimental

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

Drug: AK112

IV infusion

Drug: Etoposide

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).

Drug: Carboplatin

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)

Outcome Measures

Primary Outcome Measures

Number of patients with Grade 3 or higher adverse events (AEs) [Up to approximately 2 years]
Objective Response Rate (ORR) [Up to approximately 2 years]]
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.

Secondary Outcome Measures

Disease control rate (DCR) [Up to approximately 2 years]]
DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST V1.1
Progression free survival (PFS) [Up to approximately 2 years]]
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first)
Overall survival (OS) [Up to approximately 2 years]]
OS is the time from the date of randomization or first dosing date to death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shun Lu	Shanghai	Shanghai	China	021

Sponsors and Collaborators

Akeso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Akeso

ClinicalTrials.gov Identifier:

NCT05116007

Other Study ID Numbers:

AK112-103

First Posted:

Nov 10, 2021

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carboplatin

Etoposide

Study Results

No Results Posted as of Nov 10, 2021