Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04047862




Registration number
NCT04047862
Ethics application status
Date submitted
1/08/2019
Date registered
7/08/2019
Date last updated
1/03/2024

Titles & IDs
Public title
Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
Scientific title
Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
AdvanTIG-105
Secondary ID [2] 0 0
BGB-900-105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced and Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ociperlimab
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - 5fluorouracil
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Capecitabine

Experimental: Phase 1 - Cycle 1 (28 Days): A flat dose of ociperlimab as a single agent on Day 1. In the first cycle, 200 mg tislelizumab will be administered on Day 8.
If ociperlamib is tolerated in Cycle 1, participants will receive tislelizumab + ociperlimab sequentially on Day 29 and every 21 days for up to 8 months.

Experimental: Phase 1b Cohort 1 - Participants with metastatic squamous NSCLC will receive ociperlamib + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by ociperlimab + tislelizumab Q3W)

Experimental: Phase 1b Cohort 2 - Participants with metastatic squamous NSCLC will receive ociperlimab + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by ociperlamib+tislelizumab Q3W)

Experimental: Phase 1b Cohort 3 - Participants with metastatic NSCLC (PD-L1 positive, [TC] = 1%) will be treated with ociperlimab + tislelizumab

Experimental: Phase 1b Cohort 4 - Patients with extensive stage SCLC will be treated with ociperlimab + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by ociperlamib+tislelizumab Q3W

Experimental: Phase 1b Cohort 5 - Checkpoint inhibitor (CPI)-experienced NSCLC patients will be treated with ociperlimab plus tislelizumab

Experimental: Phase1b Cohort 6 - Patients with metastatic ESCC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W

Experimental: Phase1b Cohort 7 - Patients with metastatic EAC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W

Experimental: Phase1b Cohort 8 - Patients with recurrent or metastatic HNSCC (PD-L1 positive, vCPS= 1%) will be treated with ociperlimab + tislelizumab Q3W

Experimental: Phase1b Cohort 9 - Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + [oxalipatin + capecitabine] or [cisplatin + 5-fluorouracil] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W

Experimental: Phase 1b Cohort10 - Patients with metastatic NSCLC (PD-L1 positive, [TC] = 1%) will be treated with tislelizumab in combination with ociperlimab 450mg, 900mg or 1800mg Q3W.


Treatment: Drugs: Ociperlimab
Administered as an intravenous (IV) injection

Treatment: Drugs: Tislelizumab
Administered as an IV injection

Treatment: Drugs: Pemetrexed
Administered in accordance with local guidelines, prescribing information/summary of product

Treatment: Drugs: Paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product

Treatment: Drugs: Nab paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product

Treatment: Drugs: Carboplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Treatment: Drugs: Cisplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Treatment: Drugs: Etoposide
Administered in accordance with local guidelines , prescribing information/summary of product

Treatment: Drugs: 5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product

Treatment: Drugs: Oxaliplatin
Administered in accordance with local guidelines , prescribing information/summary of product

Treatment: Drugs: Capecitabine
Administered in accordance with local guidelines , prescribing information/summary of product
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 Dose Escalation - Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
Timepoint [1] 0 0
Up to 28 Days in Cycle 1
Primary outcome [2] 0 0
Phase 1 Dose Escalation - Number of participants experiencing Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 1.5 years
Primary outcome [3] 0 0
Phase 1 Dose Escalation - Recommended Phase Ib dose (RP2D) of ociperlimab in combination with tislelizumab
Timepoint [3] 0 0
Up to 1.5 years
Primary outcome [4] 0 0
Phase 1b Dose Confirmation - Anti-tumor activity of ociperlimab in combination with tislelizumab in patients with select advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using RECIST v. 1.1.
Timepoint [4] 0 0
Up to 1.5 years
Secondary outcome [1] 0 0
Duration of response (DOR)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Progression free survival
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Immunogenicity as assessed by the presence of anti-drug antibodies
Timepoint [4] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
Key

Phase 1 Key Inclusion Criteria

1. Has Eastern Cooperative Oncology Group (ECOG) Performance Status =1.

2. = 1 measurable lesion per RECIST v1.1.

3. Has adequate organ function.

4. phase 1- Patients with histologically or cytologically confirmed advanced, metastatic,
unresectable solid tumors who have previously received standard systemic therapy or
for which treatment is not available, not tolerated or refused.

Phase 1b Key Inclusion Criteria

1. Signed informed consent form (ICF) and able to comply with study requirements.

2. Age = 18 years (or the legal age of consent) at the time the ICF is signed.

3. Histologically or cytologically confirmed tumor types in the following disease
cohorts:

Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3:
stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage
SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV
EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9:
stage IV G/GEJ adenocarcinoma. Cohort 10: stage IV squamous or non-squamous NSCLC with
PD-L1 positive.

4. ECOG Performance Status = 1

5. Adequate organ function

6. Willing to use highly effective method of birth control

Phase 1 Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active brain or leptomeningeal metastasis.

2. Active autoimmune diseases or history of autoimmune diseases that may relapse.

3. With severe chronic or active infections requiring systemic antibacterial, antifungal
or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is
permitted for patients with hepatocellular carcinoma).

4. Concurrent participation in another therapeutic clinical trial.

5. Received prior therapies targeting TIGIT.

Phase 1b Key

1. Patients with any prior therapy for recurrent/metastatic disease.

2. Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR)
mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.

3. Gastric cancer patients with squamous or with positive HER2 expression.

4. Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint
pathways. (anti-PD(L)1 exception for Cohort 5).

5. Active leptomeningeal disease or uncontrolled brain metastasis.

6. Active autoimmune diseases or history of autoimmune diseases that may relapse.

7. With severe chronic or active infections requiring systemic antibacterial, antifungal
or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is
permitted for patients with hepatocellular carcinoma).

8. Concurrent participation in another therapeutic clinical study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
Accrual to date
Final
449
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincents Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kansas
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
Chongqing
Country [4] 0 0
China
State/province [4] 0 0
Fujian
Country [5] 0 0
China
State/province [5] 0 0
Guangdong
Country [6] 0 0
China
State/province [6] 0 0
Heilongjiang
Country [7] 0 0
China
State/province [7] 0 0
Henan
Country [8] 0 0
China
State/province [8] 0 0
Hubei
Country [9] 0 0
China
State/province [9] 0 0
Jilin
Country [10] 0 0
China
State/province [10] 0 0
Shaanxi
Country [11] 0 0
China
State/province [11] 0 0
Shandong
Country [12] 0 0
China
State/province [12] 0 0
Shanghai
Country [13] 0 0
China
State/province [13] 0 0
Sichuan
Country [14] 0 0
China
State/province [14] 0 0
Tianjin
Country [15] 0 0
China
State/province [15] 0 0
Zhejiang
Country [16] 0 0
Taiwan
State/province [16] 0 0
Kaohsiung
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taichung
Country [18] 0 0
Taiwan
State/province [18] 0 0
Taipei
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of this study are : to assess the safety and tolerability, to
determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to
determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in
combination with tislelizumab in participants with advanced solid tumors in phase 1.

Primary objective of Phase 1b is to assess overall response rate (ORR) determined by
Investigator per RECIST v1.1 for patients in each dose- expansion cohort
Trial website
https://clinicaltrials.gov/ct2/show/NCT04047862
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04047862