CompletedPhase 1

Safety and Preliminary Effectiveness of BGB-A445 in Combination With Tislelizumab in Participants With Advanced Solid Tumors

United States, Australia204 participantsStarted 2020-01-30

Plain-language summary

The purpose of this study is to assess the safety and tolerability of BGB-A445 alone and in combination with tislelizumab in participants with advanced solid tumors; and to determine the maximum tolerated dose(s) (MTD) or maximum administered dose(s) (MAD) and recommended Phase 2 doses (RP2D) of BGB-A445 alone and in combination with tislelizumab.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Participant has not received prior therapy targeting OX40 or any other T cell agonist therapy (prior checkpoint inhibitor therapy is allowed)

Exclusion criteria

✕. 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)
✕. 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:
✕. Controlled type 1 diabetes
✕. Hypothyroidism (provided it is managed with hormone-replacement therapy only)
✕. Controlled celiac disease
✕. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
✕. 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)
✕. 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)

What they're measuring

Phase 1a: Number of Participants Experiencing Adverse Events (AEs)

Timeframe: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy

Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)

Timeframe: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy

Phase 1a: Number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria

Timeframe: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy

Phase 1a: Maximum Tolerated Dose (MTD) of BGB-A445

Timeframe: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first

Phase 1b: RP2D of BGB-A445 when Administered Alone

Timeframe: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first

Phase 1b: Overall Response Rate (ORR) as Assessed by the Investigator

Timeframe: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first

Trial details

NCT IDNCT04215978

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-24

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Participant has not received prior therapy targeting OX40 or any other T cell agonist therapy (prior checkpoint inhibitor therapy is allowed)

Exclusion criteria

✕. 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)
✕. 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:
✕. Controlled type 1 diabetes
✕. Hypothyroidism (provided it is managed with hormone-replacement therapy only)
✕. Controlled celiac disease
✕. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
✕. 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)
✕. 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)

What they're measuring

Phase 1a: Number of Participants Experiencing Adverse Events (AEs)

Timeframe: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy

Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)

Timeframe: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy

Phase 1a: Number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria

Timeframe: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy

Phase 1a: Maximum Tolerated Dose (MTD) of BGB-A445

Timeframe: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first

Phase 1b: RP2D of BGB-A445 when Administered Alone

Timeframe: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first

Phase 1b: Overall Response Rate (ORR) as Assessed by the Investigator

Timeframe: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first