Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors

• Sponsor: BeiGene (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05494762
• Collaborator: (none)
• Enrollment: 254
• Locations: 7
• Arms: 2
• Anticipated Duration (Months): 36.1
• Patients Per Site: 36.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab (BGB-A317) in participants with select advanced solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: BGB-B167; Drug: Tislelizumab	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 254 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Feb 5, 2025
• Anticipated Study Completion Date: Aug 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1a: Dose Escalation Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)	Drug: BGB-B167; Intravenous administration; Drug: Tislelizumab; Intravenous administration; Other Names: BGB-A317
Experimental: Phase 1b: Dose Expansion BGB-B167 alone or in combination with tislelizumab (BGB-A317)	Drug: BGB-B167; Intravenous administration; Drug: Tislelizumab; Intravenous administration; Other Names: BGB-A317

Outcome Measures

Primary Outcome Measures

1. Phase 1a: Number of Participants Experiencing Adverse Events (AEs) [Up to approximately 3 years]

2. Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs) [Up to approximately 3 years]

3. Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria [Up to approximately 3 years]

4. Phase 1a: Maximum tolerated dose (MTD) [Up to approximately 3 years]

   MTD is defined as the highest tolerated dose with the target toxicity rate of 30%

5. Phase 1a: Recommended Phase 2 doses (RP2Ds) [Up to 90 days after the last dose of study drug(s); up to approximately 3 years]

   RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on MTD or maximum administered dose

6. Phase 1b: Objective Response Rate (ORR) [Up to approximately 3 years]

   ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

1. Phase 1a: ORR [Up to approximately 3 years]

   ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per RECIST v1.1

2. Phase 1a and 1b: Duration of Response (DOR) [Up to approximately 3 years]

   DOR is defined as the time from the first determination of a confirmed objective response until the first documentation of progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1

3. Phase 1a and 1b: Disease Control Rate (DCR) [Up to approximately 3 years]

   DCR is defined as the percentage of participants with best overall response (BOR) of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1

4. Phase 1a and 1b: Clinical Benefit Rate (CBR) [Up to approximately 3 years]

   CBR is defined as the percentage of patients with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks, as determined by investigators per RECIST v1.1

5. Phase 1b: Progression-free Survival (PFS) [Up to approximately 3 years]

   PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1

6. Phase 1a and 1b: Serum Concentration of Tislelizumab [Up to approximately 3 years]

7. Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167 [Up to approximately 3 years]

8. Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167 [Up to approximately 3 years]

9. Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167 [Up to approximately 3 years]

10. Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167 [Up to approximately 3 years]

11. Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167 [Up to approximately 3 years]

12. Phase 1a and 1b: Total body clearance (CL) of BGB-B167 [Up to approximately 3 years]

13. Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167 [Up to approximately 3 years]

14. Phase 1b: Number of Participants with AEs or SAEs [Up to approximately 3 years]

15. Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) [Up to approximately 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 or older

• Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator

• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

• Adequate organ function as indicated by laboratory values during screening or ≤ 7 days before the first dose of study drug(s)

• Lactate dehydrogenase ≤ 2.5 x upper limit of normal (ULN)

Exclusion Criteria:

• Active leptomeningeal disease or uncontrolled, untreated brain metastasis

• Active autoimmune diseases or history of autoimmune diseases that may relapse

• Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent

• History of severe hypersensitivity reactions to other monoclonal antibody products or their excipients

• Women who are pregnant or are breastfeeding

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	Tennessee Oncology	Nashville	Tennessee	United States	37203
3	Blacktown Hospital	Blacktown	New South Wales	Australia	2148
4	Ashford Cancer Centre Research	Kurralta Park	South Australia	Australia	5125
5	Monash Health	Clayton	Victoria	Australia	3168
6	Peter MacCallum Cancer Centre	Melbourne	Victoria	Australia	3000
7	Alfred Hospital	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

• BeiGene

Investigators

• Study Director: Study Director, BeiGene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BeiGene
• ClinicalTrials.gov Identifier: NCT05494762
• Other Study ID Numbers: BGB-A317-B167-101
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Aug 10, 2022