A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors

Sponsor

BeiGene (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05935098

Collaborator

(none)

318

Enrollment

Locations

Arms

18.1

Anticipated Duration (Months)

39.8

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to test the safety, tolerability, and preliminary anti-tumor activity of BGB-A3055, either alone or in combination with Tislelizumab in participants with advanced or metastatic solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor Metastatic Solid Tumor Solid Tumor	Drug: BGB-A3055 Drug: Tislelizumab	Phase 1

Detailed Description

The primary objective of the study is to assess the safety and tolerability of BGB-A3055 alone or in combination with Tislelizumab during dose escalation and to determine the recommended dose for expansion. During dose expansion, the primary objective will be to assess preliminary anti-tumor activity and further characterize the safety of the recommended dose for expansion.

. Around 318 participants will be enrolled in this study, and they will be assigned to different treatment groups. Both the participants and their doctors will be aware of which treatment group they are assigned to throughout the study.

The treatments, BGB-A3055 alone or in combination with Tislelizumab, will be administered intravenously to evaluate their safety and determine the highest dose that can be tolerated by participants. The study will be conducted at multiple medical centers worldwide. The expected duration of participation in this study is two years. Treatment will continue until participants no longer receive any benefits from the drugs, experience excessive side effects, or decide to withdraw their consent.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

318 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group 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-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy) Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels.	Drug: BGB-A3055 Administered intravenously
Experimental: Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab) Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels.	Drug: BGB-A3055 Administered intravenously Drug: Tislelizumab Administered intravenously Other Names: BGB-A317
Experimental: Phase 1b (Dose Expansion): This expansion phase will provide additional information on the safety, tolerability, and potential benefits of the recommended dose in a larger group of participants.	Drug: BGB-A3055 Administered intravenously Drug: Tislelizumab Administered intravenously Other Names: BGB-A317

Arm

Intervention/Treatment

Experimental: Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy)

Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels.

Drug: BGB-A3055

Administered intravenously

Experimental: Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab)

Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels.

Drug: BGB-A3055

Administered intravenously

Drug: Tislelizumab

Administered intravenously

Other Names:

BGB-A317

Experimental: Phase 1b (Dose Expansion):

This expansion phase will provide additional information on the safety, tolerability, and potential benefits of the recommended dose in a larger group of participants.

Drug: BGB-A3055

Administered intravenously

Drug: Tislelizumab

Administered intravenously

Other Names:

BGB-A317

Outcome Measures

Primary Outcome Measures

Phase 1a: Number of participants with adverse events (AEs) [Up to 2 Years]
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, NCI-CTCAE v5.0.
Phase 1a: Maximum tolerated dose (MTD) of BGB-A3055 [Up to 2 Years]
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 [Up to 2 Years]
The RDFEs of BGB-A3055, alone and in combination with tislelizumab will be determined based on MTD or MAD and other relevant data.
Phase 1b (Dose Expansion): Objective Response Rate (ORR) [Up to 2 Years]
Defined as the proportion of participants with best overall response (BOR) of a complete response (CR) or partial response (PR) as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

Phase 1a (Dose Escalation): Objective Response Rate (ORR) [Up to 2 Years]
ORR is defined as the percentage of participants with partial or complete response, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time to Response (TTR) [Up to 2 Years]
Defined as the time from the date of the first administration of study drug(s) to the first determination of an objective response.as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Duration of Response (DoR) [Up to 2 Years]
Defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Disease Control Rate (DCR) [Up to 2 Years]
Defined as the proportion of patients with BOR of a CR, PR, or stable disease as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Clinical Benefit Rate (CBR) [Up to 2 Years]
Defined as the proportion of patients with BOR of a CR, PR, or stable disease lasting ≥ 24 weeks as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Number of participants with anti-drug antibodies (ADAs) to BGB-A3055 [Up to 2 Years]
Number of participants with anti-drug antibodies (ADAs) to tislelizumab [Up to 2 Years]
Serum concentration of BGB-A3055 at specified time points [Up to 2 Years]
Phase 1b (Dose Expansion): Progression-Free Survival (PFS) [Up to 2 Years]
defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Phase 1b (Dose Expansion): Number of participants with adverse events (AEs) [Up to 2 Years]
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, physical examination findings, and electrocardiogram results.
CCR8 expression [Up to 2 Years]
Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab, and their association with clinical efficacy.
PD-L1 expression [Up to 2 Years]
Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab, and their association with clinical efficacy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older).
All participants are also required to demonstrate an ECOG Performance Status score of≤1 and have adequate organ function.
Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received available standard systemic therapy or for whom treatment is not available or not tolerated and could not receive any prior therapy targeting CCR8.
=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Participants should be able to provide the archival formalin-fixed paraffin-embedded (FFPE) tumor tissues (as block or unstained slides) or fresh biopsy if there is no archival tissue at baseline. For selected cohorts, participants should be willing to provide post-treatment fresh biopsy at specified timepoints.

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 (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV), and/or known history of human immunodeficiency virus (HIV)
History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases .

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
2	John Theurer Cancer Center Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
3	NEXT Dallas	Dallas	Texas	United States	75234
4	Chris O'Brien Lifehouse	Camperdown	New South Wales	Australia	2050
5	Linear Clinical Research Ltd	Nedlands	Western Australia	Australia
6	Icon Cancer Care - South Brisbane	South Brisbane		Australia
7	Centre de Lutte Contre Le Cancer - Institut Bergonie	Bordeaux		France	33076
8	Institut Curie	Paris		France	75005