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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2019/07/01
    • Registered Date : 2019/07/12
    • Last Updated Date : 2019/07/12
Background Information
1.Background  
CRIS Registration Number KCT0004139 
Unique Protocol ID AB928CSP0004 
Public/Brief Title A Study to Evaluate Immunotherapy Combinations in Participants with Lung Cancer 
Scientific Title A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Lung Cancer  
Acronym  
MFDS Regulated Study Yes
IND/IDE Protocol Yes
Registered at Other Registry Yes
Name of Registry/
Registration Number
ClinicalTrials.gov-NCT03846310 
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number UUH 2019-04-008-001 
Approval Date 2019-05-04 
Institutional Review Board  
- Name IRB of Ulsan University Hospital  
- Address IRB of Ulsan University Hospital, 877, Bangeojin sunhwando-ro, Dong-gu, Ulsan  
- Telephone 052-250-7010 
Data Monitoring Committee Yes
Dose Escalation Committee    
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Young Joo Min 
- Title Professor 
- Telephone +82-52-250-8832 
- Affiliation Ulsan Univeristy Hospital 
- Address 877, Bangeojin sunhwando-ro, Dong-gu, Ulsan 
Contact Person for Public Queries
- Name Young Joo Min 
- Title Professor 
- Telephone +82-52-250-8832 
- Affiliation Ulsan Univeristy Hospital 
- Address 877, Bangeojin sunhwando-ro, Dong-gu, Ulsan 
Contact Person for Updating Information
- Name Jiwon Baek 
- Title RoA 
- Telephone +82-2-2143-6000 
- Affiliation Novotech Asia Korea 
- Address #405, 4F, City Airport, 22 Teheran-ro 87gil, Gangnam-gu, Seoul 
Status
4. Status Status  
Study Site Multi-center (Number of center : 11) - Multi-national
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-01 , Anticipated
Target Number of Participant 45
Primary Completion Date 2021-04-30 , Anticipated
Study Completion Date 2022-03-31 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Gachon University Gil Medical Center 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 2 
- Name of Study Site Chonnam National University Hospital Hwasun Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 3 
- Name of Study Site The Catholic University of Korea, Seoul St. Mary's Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 4 
- Name of Study Site Seoul National University Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 5 
- Name of Study Site Asan Medical Center 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 6 
- Name of Study Site The Catholic University of Korea, St. Vincent's Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 7 
- Name of Study Site Yonsei University Health System, Severance Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 8 
- Name of Study Site Bundang CHA General Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 9 
- Name of Study Site Chungbuk National University Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 10 
- Name of Study Site National Cancer Center 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Recruitment Status by Participating Study Site 11 
- Name of Study Site Ulsan Univeristy Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2019-08-01 , Anticipated
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Arcus Biosciences 
- Organization Type Pharmaceutical Company  
- Project ID AB928CSP0004 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Novotech Asia Korea 
- Organization Type Others  
Sponsor Organization 2 
- Organization Name Arcus Biosciences 
- Organization Type Pharmaceutical Company  
Study Summary
7. Study Summary  
Lay Summary This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB928 in combination with carboplatin/pemetrexed with or without pembrolizumab in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC).
Objectives is to evaluate the safety and tolerability of AB928 combination therapy and AB122 monotherapy in participants with non-small cell lung cancer (NSCLC).
Trial methods
1)Dose-escalation Phase
-Arm A: Participants will receive AB928 orally QD at escalating doses in combination with standard doses of carboplatin/pemetrexed.
-Arm B: Participants will receive AB928 orally QD at escalating doses in combination with standard doses of carboplatin/pemetrexed and pembrolizumab.
2) Dose-expansion Phase
- Arm 1: Participants will receive AB928 in combination with carboplatin/pemetrexed at the RP2D determined during dose escalation in Arm A.
-Arm 2: Participants will receive AB928 in combination with carboplatin/pemetrexed and pembrolizumab at the RP2D determined during dose escalation in Arm B.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase1 
Intervention Model Others (Sequential Assignment)
Blinding/Masking Open 
Allocation Non-RCT 
Intervention Type Drug  
Intervention Description Drug: AB928, Carboplatin, Pemetrexed, Pembrolizumab
Dose escalation of AB928 in combination with carboplatin/pemetrexed and AB928 in combination with carboplatin/pemetrexed plus pembrolizumab at standard doses will be assessed in participants with advanced metastatic non-squamous Non-Small Cell Lung Cancer. In this dose escalation combination study, participants will receive oral administration of AB928 as well as IV infused carboplatin/pemetrexed with or without pembrolizumab.
Dose expansion of AB928 in combination with carboplatin/pemetrexed and AB928 in combination with carboplatin/pemetrexed plus pembrolizumab at standard doses may be assessed in participants with advanced metastatic non-squamous Non-Small Cell Lung Cancer. The dose of AB928 used will be determined based on the findings from the dose escalation phase.
Overall duration of treatment will depend on how well the treatment is tolerated.
Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.  
Number of Arms
Arm 1 Arm Label Dose Escalation Arm A 
Target Number of Participant
Arm Type Experimental 
Arm Description Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The dose expansion dose level will be determined in this part with escalating doses of AB928 in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer 
Arm 2 Arm Label Dose Escalation Arm B 
Target Number of Participant
Arm Type Experimental 
Arm Description Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The dose expansion dose level will be determined in this part with escalating doses of AB928 in combination standard doses of carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer. 
Arm 3 Arm Label Dose Expansion Arm 1 
Target Number of Participant 16 
Arm Type Experimental 
Arm Description The dose administered in expansion will be determined during dose escalation. AB928 will be administered in combination with standard carboplatin/pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer. 
Arm 4 Arm Label Dose Expansion Arm 2 
Target Number of Participant 17 
Arm Type Experimental 
Arm Description The dose administered in expansion will be determined during dose escalation. AB928 will be administered in combination with standard carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Neoplasms
Lung Cancer  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ No Limit
Description 1.Male or female participants; age ≥ 18 years
2.Pathologically confirmed nonsquamous NSCLC that is metastatic, locally advanced, or recurrent with progression.
3.Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
5.Confirm that an archival tissue sample is available and ≤ 6 months old; if not, a new biopsy of a tumor lesion must be obtained.
6.Prior chemotherapy or immunotherapy or biologic agents must have been completed at least 4 weeks before IP administration.
7.Adequate organ and marrow function  
Exclusion Criteria 1.Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
2.Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product(s) hazardous
3.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
4.Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of investigational product for non-PD-1-containing regimens and through 90 days after the last dose of investigational products for PD-1-containing regimens.
5.Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
6.Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer.
7.Prior chemotherapy, targeted small-molecule therapy, or radiation therapy within 4 weeks prior to Day 1 or has not recovered (ie, ≤ Grade 1 or baseline) from AEs due to a previously administered agent, except ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy and other AEs considered not clinically significant by the Medical Monitor and Investigator.
8.Prior use of an adenosine pathway targeting agent.
9.Participants who are eligible for potentially curative available therapies or interventions.
10.Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before investigational product administration.  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
- Outcome Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 
- Timepoint From first dose date to 90 days after the last dose (Approximately 1 year) 
Secondary Outcome(s) 1 
- Outcome AB928 Pharmacokinetic (PK) Concentration: Cmax 
- Timepoint Recorded at baseline (screening), during the first 4 cycles of treatment (4 months) and 30 days post last dose (i.e. in total approximately 6 months). Each Cycle is 28 Days 
Secondary Outcome(s) 2 
- Outcome AB928 Pharmacokinetic (PK) Concentration: Tmax 
- Timepoint Recorded at baseline (screening), during the first 4 cycles of treatment (4 months) and 30 days post last dose (i.e. in total approximately 6 months). Each Cycle is 28 Days 
Secondary Outcome(s) 3 
- Outcome Clinical Activity of AB928 combination therapy 
- Timepoint Recorded at Baseline (Screening), every 9 weeks until progression (approximately 6 months in total) 
Secondary Outcome(s) 4 
- Outcome AB928 Receptor Occupancy 
- Timepoint Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and 30 days post last dose (in total approximately 6 months). Each Cycle is 28 Days 
Secondary Outcome(s) 5 
- Outcome AB928 Immunophenotyping 
- Timepoint Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and 30 days post last dose (in total approximately 6 months). Each Cycle is 28 Days 
Secondary Outcome(s) 6 
- Outcome AB928 Gene Expression 
- Timepoint Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and 30 days post last dose (in total approximately 6 months). Each Cycle is 28 days 
Secondary Outcome(s) 7 
- Outcome AB928 Cytokines 
- Timepoint Cycle 1 Day 1 through Cycle 4 Day 1 (4 months) and 30 days post last dose (in total approximately 6 months). Each Cycle is 28 days 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No