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Protocol NumberBGB-290-AU-002
NCT Number(ClinicalTrials.gov Identfier)NCT02361723
Completed

2018-06-01 - 2020-05-31

Phase I

Terminated5

ICD-10C7A.1

Malignant poorly differentiated neuroendocrine tumors

ICD-10C7A.8

Other malignant neuroendocrine tumors

ICD-10C7B.09

Secondary carcinoid tumors of other sites

ICD-10C7B.1

Secondary Merkel cell carcinoma

ICD-10C7B.8

Other secondary neuroendocrine tumors

ICD-10C80.0

Disseminated malignant neoplasm, unspecified

ICD-10D3A.8

Other benign neuroendocrine tumors

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9199.0

Disseminated malignant neoplasm

A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation, and Expansion Study to Investigate the Safety, Pharmacokinetics, Food Effect, and Antitumor Activities of BGB-290 in Subjects with Advanced Solid Tumors

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    BeiGene, Ltd

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/10/14

Investigators and Locations

Principal Investigator Yee Chao Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 夏和雄 Division of Hematology & Oncology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming-Mo Hou
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment

Objectives

The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the Pharmacokinetics (PK) of BGB 290 in participants with advanced solid tumors.

Test Drug

BGB-290

Active Ingredient

BGB-290

Dosage Form

Capsules

Dosage

20, 40

Endpoints

Phase 1A (Parts 1 and 2):

Primary endpoints:

• The safety of BGB 290 will be assessed throughout the trial by monitoring adverse events (AEs), serious adverse events (SAEs) (as defined by NCI CTCAE version 4.03), physical examinations, and laboratory test results.

Pharmacokinetic endpoints:

• Single-dose profile: Area under the curve (AUClast) of plasma concentration from 0 to the last measurable concentration, Area under the curve (AUC) of plasma concentration from 0 to infinity, observed maximum plasma concentration (Cmax), time elapsed before the maximum plasma concentration (tmax), terminal half-life (t1/2), apparent clearance (CL/F), and apparent volume of distribution at the terminal stage (Vz/F). Steady-state: AUClast,ss, Cmax,ss, and tmax,ss.

Secondary endpoints:

• Unless specific guidelines exist for individual cancers, RECIST version 1.1 will be used to assess the number and proportion of participants achieving an objective tumor response (complete response [CR], partial response [PR], and CR+PR) or stable disease (SD) based on local radiology assessments from the first administration of the investigational drug to the end of the trial. For participants with ovarian cancer, RECIST version 1.1 and CA-125 criteria from the GCIG standard may also be used to assess tumor response. For participants with prostate cancer, the PCWG2 standard may be used by the trial administrator to assess response.

• Progression-free survival (PFS, defined as the time interval from the first administration of BGB-290 until the first confirmed disease progression [PD] or death (whichever is earlier). Participants who withdraw from the trial without confirmed progression will be limited to the last tumor assessment date on which the participant is known to be progression-free. Participants who are known to be alive but have no post-screening tumor assessment results will be limited to the first administration date of BGB 290.)

• Duration of response (CR or PR) and duration of SD (defined only as the time interval from the date of achieving the earliest qualifying response until the date of PD or death from any cause [whichever occurs earlier], if the subject's confirmed best response is CR, PR, or SD. For subjects who have achieved a qualifying response and are still alive, the duration of response will be limited to the date of the last measurable tumor assessment or the last disease progression follow-up date).

Exploratory assessment endpoints:

• Inhibition of PARP concentration in PBMCs in Phase 1A, Part 1, to determine the pharmacodynamic activity of BGB290.

• Relationship between candidate biomarkers in tissues or circulation and treatment response or disease progression.

Phase 1B:

Part A:
Primary endpoints:

• Objective response rate ([ORR]: CR + PR) as determined by the trial administrator according to RECIST version 1.1.

• PSA response as determined by the trial administrator according to PCWG2 criteria (applicable only to subjects with prostate cancer).

Secondary endpoints:
• Progression-free survival (PFS), defined as the time interval from the day of first administration of BGB 290 until the first confirmed PD or death; disease control rate ([DCR], CR+PR+SD) and clinical benefit rate ([CBR], CR + PR + durable SD [SD ≥ 24 weeks]).

• Radiological progression-free survival as determined by PCWG2 criteria (applicable only to subjects with prostate cancer).

• Time to PSA progression as determined by PCWG2 criteria (applicable only to subjects with prostate cancer).

• Safety and tolerability assessments including adverse events (AEs), severe acute exacerbations (SAEs), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory measurements.

• Steady state: Cmax and Cmin.

• CA 125 concentration (applicable only to subjects with ovarian cancer), and tumor response as determined by the GCIG CA-125 criteria: A CA-125 response is considered to have occurred if the CA 125 concentration decreases by at least 50% compared to the pre-treatment level. The response must be confirmed within 28 days of the first observation.

• In ovarian cancer, tumor response can also be assessed using the RECIST version 1.1 and GCIG CA-125 criteria.

Inclution Criteria

Key Inclusion Criteria

Phase 1A, Parts 1 and 2, and Phase 1B/Part B:

1. Written consent form signed prior to enrollment.

2. Male or female aged at least 18 years (20 years or older for Taiwanese participants).

3. Life expectancy of at least 12 weeks.

4. Histologically or cytologically confirmed malignancy that has progressed to an advanced or metastatic stage and for which there is currently no effective standard of care.

5. BRCA1/2 mutation is not mandatory, but large populations of such participants are permitted. Participants with ovarian cancer, fallopian tube cancer, primary peritoneal cancer, breast cancer, gastric cancer, SCLC, or mCRPC must consent to germline BRCA mutation testing via blood sample, even if previously tested. This is optional for previously enrolled participants.

6. East Coast Cancer Clinical Research Group (ECOG) performance status ≤ 1.

7. Ability to swallow and not vomit oral medications.

8. Adequate bone marrow, liver, and kidney function:

• ANC ≥ 1000/mm3

• Heme > 9 g/dL (transfusion-independent)

• Platelets ≥ 100,000/mm3

• Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)

• Aspartate transaminase and alanine transaminase ≤ 2.5 x ULN (≤ 5 x ULN for subjects with known liver metastases)

• Creatinine clearance ≥ 45 mL/min (calculated using the Cockcroft-Gault formula)

9. Female subjects of childbearing age and unsterilized males must use highly effective contraception during this trial and for at least 6 months after the last administration of the investigational drug.

(Applicable only to) Phase 1B/A:

1. Obtain additional subject consent for this pre-screening phase (applicable only to Phase 1B/A). 2. Males or females aged at least 18 years on the day they sign the participant consent form. (Taiwanese participants must be at least 20 years old.)

3. Subjects must have a malignant tumor that has progressed to an advanced or metastatic stage, or is in stage IV at the time of initial diagnosis, confirmed by histological or cytological examination.

4. Eligible subjects who have received at least one chemotherapy cycle in an advanced or metastatic setting may be recruited into one of the five expansion groups:

Group 1. Subjects with high-grade epithelial, non-mucinous ovarian, fallopian tube, or primary peritoneal cancer that is susceptible to platinum-based drugs and is known to have harmful or suspected harmful germline or somatic BRCA1/2 mutations, or have HR deficiency, and must meet the following criteria:

a. Received at least one first-line platinum-based therapy in an advanced or metastatic setting.

b. Must not have progressed, or have relapsed within 6 months of the end of the previous platinum-based therapy cycle.

Note: Subjects who meet the criterion of susceptibility to platinum-based drugs can receive additional therapy after their previous platinum-based therapy cycle.

i. Subjects with tumors carrying harmful or suspected harmful BRCA1 or BRCA2 mutations, regardless of molecular imprinting results, are classified as HRD-positive.

ii. If HRD testing or BRCA mutation status is unclear prior to enrollment, pre-screening tissue testing using the Myriad myChoice® diagnostic test is mandatory, and a separate subject consent form for HRD tissue testing must be used.

Group 2. Subjects with TNBC who meet the following criteria:

a. Subjects with tumors carrying harmful or suspected harmful BRCA1 or BRCA2 mutations, regardless of molecular imprinting results, are classified as HRD-positive.

i. If HRD testing or BRCA mutation status is unclear prior to enrollment, pre-screening tissue testing using the Myriad myChoice® diagnostic test is mandatory, and a separate subject consent form for HRD tissue testing must be used.

b. The number of platinum-based therapies received in any treatment context is 0-1. Note: Subjects may receive other therapies since their last platinum-based treatment, provided other eligibility criteria are met.

c. In advanced or metastatic settings, the patient has received ≤3 lines of therapy.

Group 3. Subjects with mCRPC (including but not limited to mutations within the HR pathway and/or as defined by the HRD pathway) must meet the following criteria:

a. Subjects with known or suspected harmful germline or somatic BRCA1/2 mutations, regardless of molecular imprinting results, are classified as HRD-positive.

i. If HRD testing or BRCA mutation status is unclear prior to enrollment, pre-screening tissue testing using the Myriad myChoice® diagnostic test is mandatory, along with a separate subject consent form specifically for HRD tissue testing.

b. Subjects may not have received chemotherapy, or may not have received more than two cycles of taxane-containing chemotherapy, including docetaxel and carbazitaxel. If docetaxel is used more than once, it will be considered one cycle.

c. Subjects may not have received treatment with a novel androgen receptor-targeted therapy (e.g., abiraterone and/or enzalutamide), or may have received prior treatment.

d. At least 14 days have passed since the completion of previous treatment with flutamide, bicalutamide, and nilutimide, or enzalutamide and abiraterone.

e. At least 14 days have passed since any radiotherapy; except for single-shot radiotherapy for palliative purposes (limited to a single field).

f. Confirmed prostate cancer and meeting one of the following criteria:

• Improved prostate-specific antigen (PSA) levels, defined as at least three sustained increases in PSA concentration at least one week apart. PSA levels at screening follow-up should be at least 2 µg/L (2 ng/mL).

• Radiographically improved soft tissue disease as determined by RECIST 1.1 (Revised).

• Has undergone surgical or medical castration. Testosterone levels do not need to be checked as long as the subject is still undergoing chemical castration or has undergone surgical castration >4 months ago. In all cases, luteinizing hormone-releasing hormone (LHRH) antagonists/agonists should continue to be used in these subjects.

• Subjects with only unmeasurable bone lesions must have experienced progression (more than two new lesions) or PSA progression before enrollment.

Group 4. Subjects with high-stage SCLC must meet the following criteria:

a. Received ≤2 lines of therapy.

Group 5. Subjects with gastric cancer must meet the following criteria:

a. Received ≤2 lines of therapy.

5. Subjects must have a measurable disease as defined in RECIST version 1.1, with the following exceptions:

a. Subjects with ovarian cancer but no measurable disease may still be considered if, after discussion with the sponsoring manufacturer's medical supervisor, it is determined that the disease can be assessed according to the GCIG CA-125 criteria.

b. Subjects with prostate cancer and only unmeasurable bone lesions must have two or more new lesions or PSA progression before enrollment.

6. ECOG performance status ≤ 1.

7. Life expectancy at least 12 weeks.

8. Subjects must have adequate organ function, as indicated by the following laboratory test values:

 ANC ≥ 1,500/mL
 Platelets ≥ 100,000/mL
 Heme ≥ 9 g/dL or ≥ 5.6 mmol/L (not dependent on transfusion)
 Creatinine clearance ≥ 45 mL/min (calculated using the Cockcroft-Gault formula)
 Total serum bilirubin ≤ 1.5 X ULN
 AST (serial glutamate-oxalate-acetate transaminase [SGOT]) and ALT (serial glutamate-pyruvate transaminase [SGPT]) ≤ 2.5 X ULN; for subjects with liver metastases, ≤ 5 X ULN

9. Subjects have voluntarily agreed to participate by signing a written subject consent form.

10. Female subjects of childbearing age and unsterilized men must use highly effective contraception during this trial and for at least 6 months after the last administration of the investigational drug.

11. Able to swallow oral medications without vomiting.

Exclusion Criteria

Exclusion Criteria

1. Pregnant or breastfeeding female subjects.

2. Subjects who have previously received poly(adenosine diphosphate-ribose) polymerase (PARP) targeted therapy.

3. Applicable only to Phase 1B/Part A: Subjects deemed unresponsive to platinum-based therapy (e.g., disease progression detected at the first tumor assessment during platinum-based therapy).

4. Subjects who have received chemotherapy, biotherapy, immunotherapy, or other investigational drug treatments (or have not yet recovered from side effects of such treatments) within five half-lives of their previous treatment or within four weeks prior to starting the investigational drug (whichever is longer).

5. Subjects who have undergone major surgery/surgical treatment for any reason within four weeks prior to the screening follow-up visit. Subjects must have recovered from such treatment and be clinically stable prior to enrollment in this trial.

6. Subjects whose target lesions have previously received therapeutic radiation therapy.

7. Subjects who have received palliative radiotherapy to control local symptoms at non-target lesions within the past 21 days must have recovered from any adverse reactions to radiotherapy before screening symptoms are recorded.

8. Subjects with unresolved grade >1 toxicities caused by previous cancer therapy (as determined by NCI CTCAE version 4.03), excluding adverse events (AEs) deemed not to pose a safety risk by the trial administrator (e.g., hair loss).

9. Subjects with a known history of immediate or delayed allergic or idiopathic reactions to chemically related drugs or any component of BGB-290 (currently, there are no chemically related drugs approved by the FDA for use in the United States).

10. Leptomeningeal disease.

11. Untreated brain metastases. Subjects with previously treated brain metastases are eligible to participate if their brain metastases have not worsened on CT or MRI scans of the brain for at least 28 days, they have no symptoms caused by brain metastases, and they have been on a stable or tapering dose of corticosteroids for at least 28 days.

12. Subjects with any unstable, pre-existing major medical conditions deemed by the trial administrator to preclude the use of the investigational drug, including active infections or known positive human immunodeficiency virus (HIV).

13. Untreated individuals with chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA > 500 IU/mL, or those with active hepatitis C. This trial may include inactive hepatitis B surface antigen (HBsAg) carriers, subjects with treated and stable hepatitis B (defined as HBV DNA < 500 IU/mL), and subjects cured of hepatitis C.

14. Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticulosis, or a history of total gastrectomy or gastric banding surgery.

a. Subjects with gastroesophageal reflux disease currently being treated with proton pump inhibitors are permitted (assuming no potential drug interactions).

15. Active cardiac disease
a. Evidence of current myocardial ischemia
b. Symptomatic pulmonary embolism
c. Acute myocardial infarction within ≤6 months prior to Day 1 of the trial
d. New York Heart Association (NYHA) grade 3 or 4 heart failure within ≤6 months prior to Day 1 of the trial
e. Ventricular arrhythmia grade ≥2 within ≤6 months prior to Day 1 of the trial
f. Cerebrovascular accident within ≤6 months prior to Day 1 of the trial

16. Psychological, familial, social, or geographical circumstances that prevent the subject from cooperating with the trial program.

17. The trial administrator determines, through medical interviews, physical examinations, or screening tests, that the subject is unsuitable for inclusion in this trial.

18. Currently using any of the medications listed in Section 8.3.2 of the treatment plan.

19. Eligible for curative therapy.

20. Unable or unwilling to cooperate with receiving necessary treatment.

The Estimated Number of Participants

  • Taiwan

    6 participants

  • Global

    100 participants

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