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Funding terminated due to business reasons
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The primary objectives of Part 1 of this study are to:
The primary objective of Part 2 of this study is to determine the objective response rate (ORR) as assessed by initial investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with BGB-3245 and panitumumab combination treatment at the RP2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Finding Part | Experimental | Participants with advanced or metastatic CRC and with known mutation status and tumor harboring an oncogenic mutation of BRAF, KRAS, or NRAS and with documented disease progression by RECIST during or after at least 1 line of prior therapy will be enrolled into 4 planned sequentially run cohorts. Participants will receive escalating doses of BGB-3245 in combination with panitumumab to establish the MTD and RP2D by assessing the safety, tolerability, preliminary antitumor activity, and pharmacokinetics (PK) for the combination of BGB-3245 with panitumumab. |
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| Part 2: Dose Expansion Part, Group 1 | Experimental | Participants with advanced or metastatic CRC that harbors KRAS or NRAS mutations who have been treated and had documented disease progression by RECIST criteria during or after at least 1 line of prior therapy. Participants will receive the RP2D of BGB-3245 in combination with panitumumab to further evaluate the safety, PK, and assess the preliminary antitumor activity of the RP2D of the BGB-3245 and panitumumab combination. |
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| Part 2: Dose Expansion Part, Group 2 | Experimental | Participants with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) that harbors KRAS mutations who have been treated and had documented disease progression by RECIST criteria during or after at least 1 line of prior therapy. Participants will receive the RP2D of BGB-3245 in combination with panitumumab to further evaluate the safety, PK, and assess the preliminary antitumor activity of the RP2D of the BGB-3245 and panitumumab combination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-3245 | Drug | Oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Serious Adverse Events (SAEs) | Up to approximately 2 years | |
| Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to approximately 2 years | |
| Part 1: Number of Participants with Adverse Events of Special Interest (AESIs) | Up to approximately 2 years | |
| Part 1: Number of Participants with Interruptions to Dosing with BGB-3245 | Up to approximately 2 years | |
| Part 1: Number of Participants with Reductions in Dosing with BGB-3245 | Up to approximately 2 years | |
| Part 1: MTD of BGB-3245 | Up to approximately 2 years | |
| Part 1: RP2D of BGB-3245 | Up to approximately 2 years | |
| Part 2: ORR as Assessed by Initial Investigator Review | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Plasma Concentrations of BGB-3245 and Any Relevant Metabolites | Day 1 of each 28 day cycle (up to approximately 2 years) | |
| Part 1: ORR as Assessed by Investigator Review using RECIST v1.1 | Up to approximately 2 years |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria apply. Summary of key criteria provided.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center - Duarte | Duarte | California | 91010 | United States | ||
| Duke Cancer Institute |
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| Panitumumab | Drug | Intravenous (IV) infusion via an infusion pump |
|
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| Part 2: ORR as Assessed by Central Review | Up to approximately 2 years |
| Part 1 and 2: Duration of Response (DoR) | Up to approximately 2 years |
| Part 1 and 2: Disease Control Rate (DCR) | Up to approximately 2 years |
| Part 1 and 2: Progression Free Survival (PFS) | Up to approximately 2 years |
| Part 2: Number of Participants with SAEs | Up to approximately 2 years |
| Part 2: Number of Participants with TEAEs | Up to approximately 2 years |
| Part 2: Number of Participants with AESIs | Up to approximately 2 years |
| Part 2: Number of Participants with Interruptions to Dosing with BGB-3245 | Up to approximately 2 years |
| Part 2: Number of Participants with Reductions in Dosing with BGB-3245 | Up to approximately 2 years |
| Durham |
| North Carolina |
| 27710 |
| United States |
| USOR - Virginia Cancer Specialists - Fairfax Office | Fairfax | Virginia | 22031 | United States |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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