New drug combo aims to boost immune system against Hard-to-Treat cancers

NCT ID NCT04215978

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a combination of two immunotherapy drugs, BGB-A445 and tislelizumab, in 204 people with advanced solid tumors including lung, head and neck, and nasopharyngeal cancers. The main goals were to check safety and find the best dose. The trial is now complete, and results will help guide future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BGB-A445 (gimistotug) and tislelizumab
What this could lead to: If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong: This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The combination may cause significant side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

204 people

The number who actually took part.

Started

Jan 2020

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1\. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused. 1. Enrollment will be limited to participants with advanced solid tumors for which there is clinical evidence of response to T cell based immuno-oncology agents (eg, anti PD 1) or other scientific evidence in support of an immunologically sensitive tumor type. 2. Participant has not received prior therapy targeting OX40 or any other T cell agonist therapy (prior checkpoint inhibitor therapy is allowed) 2\. Phase 1b, the dose expansion phase, aims to include participants in specific tumor type cohorts who do not have access to standard systemic treatment, cannot tolerate it, or it is deemed inappropriate by the investigator. Cohort 1 focuses on non-small cell lung cancer (NSCLC) patients with advanced or metastatic disease, while Cohort 2 involves individuals with recurrent or metastatic head and neck squamous cell cancer (HNSCC). Cohort 3 includes participants with nasopharyngeal carcinoma (NPC), and Cohort 4 is for NSCLC patients with PD-L1 expression of at least 50%. Each cohort has specific eligibility criteria related to prior therapies, tumor characteristics, and treatment-free intervals. 3\. Has at least 1 measurable lesion as defined per RECIST 1.1. The target lesion(s) selected have not been previously treated with local therapy OR the target lesion(s) selected that are within the field of prior local therapy have subsequently progressed as defined by RECIST 1.1 4. Participants should be able to provide tumor tissue sample 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 and a life expectancy of ≥ 6 months. 6\. Adequate organ function as indicated by the following laboratory values up to first dose of study drug a. Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection for the following: * Absolute neutrophil count ≥ 1.5 x 10\^9/L * Platelet count ≥ 75 x 10\^9/L * Hemoglobin ≥ 90 g/L b. Estimated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 determined by the Cockcroft-Gault formula without correction for body surface area (BSA) * The estimated GFR for participants with renal cell carcinoma must be ≥ 30 mL/min/1.73 m\^2 by the Cockcroft-Gault formula c. Serum total bilirubin ≤ 1.5 x ULN (\< 3 x ULN for participants with Gilbert syndrome) d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; * ≤ 5 x ULN for participants with hepatocellular carcinoma or liver metastases Key Exclusion Criteria: 1. Active leptomeningeal disease or uncontrolled brain metastasis. Participants with equivocal findings or with confirmed brain metastases are eligible for enrollment provided they are asymptomatic and radiologically stable without the need for corticosteroid treatment for at least 4 weeks prior to the first dose of study drug(s) 2. Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy, with the following exceptions: 1. Controlled type 1 diabetes 2. Hypothyroidism (provided it is managed with hormone-replacement therapy only) 3. Controlled celiac disease 4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia) 5. Any other disease that is not expected to recur in the absence of external triggering factors (requires consultation with the medical monitor prior to enrollment) 3. Any active malignancy ≤ 2 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) 4. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s), with the following exceptions: 1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) 2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption 3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen) 5. Any major surgical procedure occurring ≤ 28 days before the first dose of study drug(s). If surgical procedure occurs \> 28 days, they must have recovered adequately from the toxicity NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma nasopharyngeal carcinoma neoplasm non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Head and neck squamous cell carcinoma HNSCC Nasopharyngeal carcinoma (NPC) Non-small cell lung cancer

Contacts and locations

Locations

Affiliated Zhongshan Hospital Of Fudan University

Shanghai, Shanghai Municipality, 200032, China
Auckland City Hospital

Auckland, 1023, New Zealand
Blacktown Cancer And Haematology Centre

Blacktown, New South Wales, 2148, Australia
California Cancer Associates for Research & Excellence (cCARE)

San Diego, California, 92127, United States
Cha Bundang Medical Center, Cha University

Gyeonggido, Gyeonggi-do, 13496, South Korea
Changhua Christian Hospital

Changhua, NAP, 500-06, Taiwan
Jinan Central Hospital

Jinan, Shandong, 250013, China
King Chulalongkorn Memorial Hospital (Chulalongkorn University)

Bangkok, 10330, Thailand
Linear Clinical Research

Nedlands, Western Australia, 6009, Australia
Linyi Cancer Hospital

Linyi, Shandong, 276001, China
Monash Health

Clayton, Victoria, 3168, Australia
National Cancer Center (NCC)

Goyang-si, Gyeonggi-do, 10408, South Korea
National Cheng Kung University Hospital

Tainan, 704, Taiwan
Nucleus Network

Melbourne, Victoria, 3004, Australia
Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia
Pindara Private Hospital

Benowa, Queensland, 4217, Australia
Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia
Ramathibodi Hospital Mahidol University

Bangkok, 10400, Thailand
Sarawak General Hospital

Kuching, 93586, Malaysia
Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, 13620, South Korea
Severance Hospital Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 03722, South Korea
Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China
Srinagarind Hospital (Khon Kaen University)

Muang, 40002, Thailand
The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea
The Second Xiangya Hospital Of Central South University

Changsha, Hunan, 410011, China
UPMC Hillman Cancer Center (Univ Of Pittsburgh)

Pittsburgh, Pennsylvania, 15232, United States
Union Hospital Of Tongji Medical College, Huazhong University Of Science And Technology

Wuhan, Hubei, 430022, China
University of Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia
Valkyrie Clinical Trials

Los Angeles, California, 90067, United States
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

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