A Study of E7386 in Participants With Advanced Solid Tumor Including Colorectal Cancer (CRC)

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to assess the safety and tolerability of E7386 in participants with solid tumor including CRC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.

Criteria

Inclusion Criteria:

1. Participants must have any of the following tumor types:

1. Dose Escalation Part: Participants with advanced, unresectable, or recurrent solid tumor including CRC for which no alternative standard therapy or no effective therapy exists

2. Expansion Part: Participants with advanced, unresectable, or recurrent CRC in third- or later-line, Or subjects with other gastrointestinal tumors such as small bowel carcinoma and gastrointestinal neuroendocrine tumors after at least 1 prior systemic chemotherapy regimen upon discussion and agreement with the sponsor

2. Dose Escalation Part: Participants with CRC must consent to biopsy and submit the archival tumor tissue if it is stored.

Expansion part: Participants with accessible tumors must consent to tumor biopsy. Participants with inaccessible tumors may be enrolled without a biopsy upon consultation and agreement by the sponsor. Participants must consent to submit the archival tumor tissue if it is stored.

3. Life expectancy of >=12 weeks.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

5. All AEs due to previous anti-cancer therapy have either returned to Grade 0-1 except for alopecia and Grade 2 peripheral neuropathy (renal/bone marrow/liver function should meet the inclusion criteria).

6. Adequate washout period before study drug administration:

1. Chemotherapy and radiotherapy: 3 weeks or more

2. Any therapy with antibody: 4 weeks or more

3. Any investigational drug or device: 4 weeks or more

4. Blood/platelet transfusion or Granulocyte-colony stimulating factor (G-CSF): 2 weeks or more

7. Adequate renal, bone marrow, liver function, and serum mineral level.

8. At least one measurable lesion based on RECIST 1.1.

9. Participants must agree to take Vitamin D continuous supplementation as per local institutional guideline/ investigators clinical discretion when 25-hydroxyvitamin D levels less than ng/mL (nanogram per milliliter).

10. Dose escalation part: Participants must consent to skin biopsies from skin tissue that is tumor-free during the study. Expansion part: Initial At least 5 participants in each dose level must consent to skin biopsies from skin tissue that is tumor-free during the study. Participants may be enrolled without skin biopsies upon consultation and agreement by the sponsor.

Exclusion Criteria:

1. Known to be human immunodeficiency virus (HIV) positive.

2. Active infection requiring systemic treatment.

3. Diagnosed with meningeal carcinomatosis.

4. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example: radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.

5. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.

6. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (example: nausea, diarrhea, or vomiting) that might impair the bioavailability of E7386.

7. Any of bone disease/conditions as follows;

1. Osteoporosis with T-score less than (<) -2.5 by Dual energy X-ray absorptiometry (DXA) scan

2. Fasting Beta-isomerised carboxy terminal telopeptide of type I collagen (β-CTX) (serum) Dose escalation part: greater than (>) 1000 picograms per milliliter (pg/mL) Expansion part: Participant who do not agree to start the treatment of anti-resorptive agent (example: bisphosphonate) when fasting β-CTX (serum) >1000 pg/mL and Grade 1 osteoporosis

3. Osteomalacia

4. Symptomatic hypercalcemia requiring bisphosphonate therapy

5. History of any fracture within 6 months prior to starting study drug

6. Any condition requiring orthopedic intervention

7. For participants with bone metastases, lack of treatment with a bisphosphonate or denosumab (participants with previous solitary bone lesions controlled with radiotherapy are eligible)

8. History of active malignancy (except for original disease, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the bladder or cervix, or early stage gastric/colorectal cancer) within the past 24 months prior to the first dose of study drug.

9. Prior treatment with E7386.