Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
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| ClinicalTrials.gov Identifier: NCT02407990 |
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Recruitment Status :
Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : November 9, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Cancer | Biological: BGB-A317 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 451 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Subjects With Advanced Tumors |
| Actual Study Start Date : | June 2, 2015 |
| Estimated Primary Completion Date : | January 31, 2021 |
| Estimated Study Completion Date : | January 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: BGB-A317 Phase 1A |
Biological: BGB-A317
In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the schedule exploration part, participants will be assigned to doses and dose schedules. In the fix dose exploration, participants will be assigned to dose group(s) not to exceed the Maximum Tolerated Dose (MTD). In the dose expansion part, participants will be assigned to different groups based on their tumor type. |
| Experimental: BGB-A317 Phase 1B |
Biological: BGB-A317
Participants will be assigned to different groups based on their tumor types |
- Phase 1A: Number of participants with adverse events [ Time Frame: From first dose to within 30 days of last dose of BGB-A317, up to 2 years and 1 month ]
- Phase 1B: Overall response based on RECIST v 1.1 in participants with select tumor types by the Investigators [ Time Frame: Performed at an expected average of 10 weeks during treatment period (up to 2 years) and within 30 days of last dose of BGB-A317 during follow-up period ]
- Phase 1A: Area under the plasma concentration-time curve (AUC) [ Time Frame: During first 4 months ]
- Phase 1A: Maximum plasma concentration (Cmax) [ Time Frame: During first 4 months ]
- Phase 1A: Time to reach maximum plasma concentration (Tmax) [ Time Frame: During first 4 months ]
- Phase 1A: Terminal elimination half-life (t1/2) [ Time Frame: During first 4 months ]
- Phase 1A: Disease assessment by CT/MRI scan [ Time Frame: Performed at an expected average of 10 weeks during treatment period (up to 2 years) and within 30 days of last dose of BGB-A317 during follow-up period ]
- Phase 1A: Anti-BGB-A317 antibody [ Time Frame: Performed at an expected average of 6 weeks during treatment period (up to 2 years) and within 30 days of last dose of BGB-A317 during follow-up period ]
- Phase 1B: Disease assessment by CT/MRI scan [ Time Frame: Performed at an expected average of 10 weeks during treatment period (up to 2 years) and within 30 days of last dose of BGB-A317 during follow-up period ]
- Phase 1B: Number of participants with adverse events [ Time Frame: From first dose to within 30 days of last dose of BGB-A317, up to 2 years and 1 month ]
- Phase 1B: Plasma concentration [ Time Frame: During first 4 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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Participants must have a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy is available.
- For Phase 1A: no specific restriction
- For Phase 1B: histology specified below
i. NSCLC (Participants with documented epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement should be excluded) ii. ovarian cancer iii. gastric cancer iv. HCC (Barcelona-Clinic Liver Cancer stage C, stage B not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach, and Child-Pugh A) v. HNSCC vi. esophageal carcinoma vii. Triple Negative Breast Cancer (TNBC) viii. cholangiocarcinoma ix. Renal Cell Cancer (RCC), bladder cancer, melanoma, Merkel-cell carcinoma, sarcoma, gastrointestinal stromal tumor (GIST), or Cutaneous squamous cell carcinoma (cuSCC). Or any other solid tumors with known microsatellite instability-high (MSI-H) or deficient MisMatch Repair (dMMR) status, such as Colorectal Cancer (CRC) or pancreatic cancer
- Participants with previously treated brain metastasis (es) that is asymptomatic or radiographically/clinically stable and not requiring steroids medications for 4 weeks prior to enrollment are permitted.
- Participants must have archival tumor tissues or agree to a tumor biopsy for analysis of predictive biomarkers such as PD-L1. (Fresh tumor biopsies are strongly recommended at baseline for biomarker analysis in participants with readily accessible tumor lesions and who consent to the biopsies.)
- Participants must have measurable disease as defined per RECIST Version 1.1.
- Male or female and ≥18 years of age on day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
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Participants must have adequate organ function as indicated by the following laboratory values.
- Absolute neutrophil count (ANC) ≥1,500 /mL
- Platelets ≥100,000 / mL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications
- Serum creatinine ≤1.5 X upper limit of normal (ULN)
- Serum total bilirubin ≤ 1.5 X ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for participants with liver metastases
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN
Key Exclusion Criteria:
- History of severe hypersensitivity reactions to other Monoclonal antibodies (mAbs).
- Prior malignancy active within the previous 2 years except for tumor for which a participant is enrolled in the study, and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
- Prior therapies targeting PD-1 or PD-L1.
- Participants who fail to meet enrollment criteria for other PD-1 or PD-L1 trials solely due to low or negative predictive biomarkers.
- Participants with active autoimmune diseases or history of autoimmune diseases should be excluded.
- Participants should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
- Has history of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies..
- Known history of Human Immunodeficiency Virus;
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Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) except in participant with HCC, who meet the following criteria:
- HBV viral load (VL) <200 IU/mL (approximately 1000 cps/mL)
- Participants with active Hepatitis B Virus (HBV) infection need to be on anti-HBV suppression ≥3 months, throughout treatment and for 6 months after
- Participants Hepatitis C Virus (HCV)-positive after successful treatment (defined as sustained virologic response [SVR] 12 or SVR 24) are allowed as long as 4 weeks have passed between completion of HCV therapy and start of study drug
- Use of any vaccines against infectious diseases (e.g., influenza, varicella, etc.) within 4 weeks (28 days) of initiation of study therapy and 60 days after the last administration of the study medication.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407990
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| Principal Investigator: | Jayesh Desai, MD | Peter MacCallum Cancer Centre, Australia |
| Responsible Party: | BeiGene |
| ClinicalTrials.gov Identifier: | NCT02407990 |
| Other Study ID Numbers: |
BGB-A317_Study_001 |
| First Posted: | April 3, 2015 Key Record Dates |
| Last Update Posted: | November 9, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Upon request, and subject to certain criteria, conditions, and exceptions, BeiGene will provide access to individual de-identified participant data from BeiGene-sponsored global interventional clinical studies conducted for medicines for indications that have been approved or in programmes that have been terminated. BeiGene will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data requests can be submitted to medicalinformation@beigene.com. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |