A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2021-01-29

Brief Summary

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This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination with immunotherapy in adult patients with advanced cancers. The goal of the study is to determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combo with Ipilimumab

Group Type EXPERIMENTAL

BBI608

Intervention Type DRUG

Patients in this trial will receive BBI608 at assigned dose-levels according to the study arm the patient is enrolled into. BBI608 Dose Level 1: 240 mg twice daily, Dose Level 2: 480 mg twice daily. The assigned dose of BBI608 will be administered twice daily with approximately 12 hours between doses.

Ipilimumab

Intervention Type DRUG

Ipilimumab 3 mg/kg is administered intravenously over 90 minutes every 21 days for a total of 4 doses.

Combo with Nivolumab

Group Type EXPERIMENTAL

BBI608

Intervention Type DRUG

Patients in this trial will receive BBI608 at assigned dose-levels according to the study arm the patient is enrolled into. BBI608 Dose Level 1: 240 mg twice daily, Dose Level 2: 480 mg twice daily. The assigned dose of BBI608 will be administered twice daily with approximately 12 hours between doses.

Nivolumab

Intervention Type DRUG

Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes every 14 days.

Combo with Pembrolizumab

Group Type EXPERIMENTAL

BBI608

Intervention Type DRUG

Patients in this trial will receive BBI608 at assigned dose-levels according to the study arm the patient is enrolled into. BBI608 Dose Level 1: 240 mg twice daily, Dose Level 2: 480 mg twice daily. The assigned dose of BBI608 will be administered twice daily with approximately 12 hours between doses.

Pembrolizumab

Intervention Type DRUG

Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every 21 days.

Interventions

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BBI608

Patients in this trial will receive BBI608 at assigned dose-levels according to the study arm the patient is enrolled into. BBI608 Dose Level 1: 240 mg twice daily, Dose Level 2: 480 mg twice daily. The assigned dose of BBI608 will be administered twice daily with approximately 12 hours between doses.

Intervention Type DRUG

Ipilimumab

Ipilimumab 3 mg/kg is administered intravenously over 90 minutes every 21 days for a total of 4 doses.

Intervention Type DRUG

Nivolumab

Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes every 14 days.

Intervention Type DRUG

Pembrolizumab

Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every 21 days.

Intervention Type DRUG

Other Intervention Names

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Napabucasin BB608 BBI-608 Yervoy Opdivo Keytruda

Eligibility Criteria

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Inclusion Criteria

1. Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
2. A histologically or cytologically confirmed cancer that is metastatic, unresectable, or recurrent and for which treatment with ipilimumab, or nivolumab, or pembrolizumab is a reasonable therapeutic option in the opinion of the investigator.
3. ≥ 18 years of age
4. Measurable disease as defined by Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last dose
7. Females of childbearing potential must have a negative serum pregnancy test
8. Aspartate transaminase (AST) \< 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN).
9. Hemoglobin (Hgb) ≥ 9 g/dl
10. Total bilirubin ≤ 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin \< 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor.
11. Creatinine ≤ 1.5 × ULN or, for patients with creatinine levels above institutional upper limit of normal, creatinine clearance must be \> 60 mL/min/1.73 m\^2.
12. Absolute neutrophil count ≥ 1.5 x 10\^9/L
13. Platelets ≥ 100 x 10\^9/L; patients with hepatocellular carcinoma may enroll provided they have a platelet count ≥ 75 x 10\^9/L.
14. Life expectancy ≥ 3 months

Exclusion Criteria

1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI608. Patients may begin BBI608 on a date determined by the investigator and medical monitor for the sponsor after a minimum of 7 days since last receiving anti-cancer treatment, provided that all treatment-related adverse events (AEs) have resolved or have been deemed irreversible
2. Had a surgical procedure requiring general anesthesia or inpatient hospitalization for recovery less than 4 weeks prior to beginning protocol therapy.
3. Any known, untreated, brain metastases. Treated subjects must be stable 4 weeks after completion of treatment for brain metastases and image documented stability is required. Patients must have no clinical symptoms from brain metastases and have not required systemic corticosteroids \>10 mg/day prednisone or equivalent for at least 2 weeks prior to first dose of study drug.
4. Pregnant or breastfeeding
5. Unable or unwilling to swallow BBI608 capsules daily
6. Significant gastrointestinal disorder(s) (e.g., active Crohn's disease or ulcerative colitis, or a history of extensive gastric resection and/or small intestinal resection) such that absorption of oral medications is impaired.
7. Has an active autoimmune disease requiring immunosuppression with the exception of subjects with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and euthyroid patients with a history of Grave's disease.
8. Has interstitial lung disease or active, non-infectious pneumonitis
9. Has a transplanted organ or has undergone allogeneic bone marrow transplant
10. Has received a live vaccine within 30 days prior to first dose.
11. Known hypersensitivity to a component of protocol therapy
12. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or on mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
13. Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; c) localized prostate cancer not requiring systemic therapy; and c) other primary tumors with no known active disease present that, in the opinion of the investigator and medical monitor for the sponsor, will not affect patient outcome in the setting of the current diagnosis.
14. Abnormal ECGs that are clinically significant such as QT prolongation (QTc \> 480 msec), clinically significant cardiac enlargement or hypertrophy, new bundle branch block or existing left bundle branch block, or signs of new, active ischemia.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No