Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors

• Status: Completed
• Trial end date: 2017-12-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC) dosed three times every four weeks (3q4wk) in a mixed population of patients with specified solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genmab; Seagen Inc.
• Collaborator: Genmab
• Treatments: Tisotumab vedotin

Criteria

Inclusion Criteria:

• Patients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy.

Patients must have measurable disease according to RECIST v1.1

• Age ≥ 18 years.

• Acceptable renal function.

• Acceptable liver function.

• Acceptable hematological status (hematologic support allowed under certain circumstances).

• Acceptable coagulation status.

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Life expectancy of at least three months.

• A negative serum pregnancy test (if female and aged between 18-55 years old).

• Women who are pregnant or breast feeding are not to be included.

• Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of HuMax-TF-ADC.

• Following receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out.

Exclusion Criteria:

• Known past or current coagulation defects.

• Diffuse alveolar hemorrhage from vasculitis.

• Known bleeding diathesis.

• Ongoing major bleeding.

• Trauma with increased risk of life-threatening bleeding.

• Have clinically significant cardiac disease.

• A baseline QT interval as corrected by Fridericia's formula (QTcF) > 450 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block.

• Therapeutic anti-coagulative or long term anti-platelet treatment except use of low dose acetylsalicylic acid (ASA) up to 81 mg/day and non-ASA nonsteroidal anti-inflammatory drugs (NSAIDs).

• Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support within one week or pegylated G-CSF within two weeks before the Screening Visit.

• Have received a cumulative dose of corticosteroid ≥ 150 mg (prednisone or equivalent doses of corticosteroids) within two weeks before the first infusion.

• No dietary supplements allowed during the study period, except multivitamins, vitamin D and calcium.

• Major surgery within six weeks or open biopsy within 14 days before drug infusion.

• Plan for any major surgery during treatment period.

• Patients not willing or able to have a pre-trial tumor biopsy taken (the screening biopsy can be omitted if archived material is available).

• Presence or anticipated requirement of epidural catheter in relation to infusions (within 48 hours before and after dose of trial drug).

• Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.

• Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within four weeks or five half lives, whichever is longest, before first infusion.

• Prior treatment with bevacizumab within twelve weeks before the first infusion.

• Prior therapy with a conjugated or unconjugated auristatin derivative.

• Radiotherapy within 28 days prior to first dose.

• Patients who have not recovered from symptomatic side effects of radiotherapy at the time of initiation of screening procedure.

• Known past or current malignancy other than inclusion diagnosis, except for:

• Cervical carcinoma of Stage 1B or less.

• Non-invasive basal cell or squamous cell skin carcinoma.

• Non-invasive, superficial bladder cancer.

• Prostate cancer with a current PSA level < 0.1 ng/mL.

• Breast cancer in BRCA1 or BRACA2 positive ovarian cancer patients.

• Any curable cancer with a complete response (CR) of > 5 years duration.

• Radiographic evidence of cavitating pulmonary lesions and tumor adjacent to or invading any large blood vessel unless approved by sponsor.

• Ongoing, significant , uncontrolled medical condition.

• Presence of peripheral neuropathy.

• Active viral, bacterial or fungal infection requiring intravenous treatment with antimicrobial therapy starting less than four weeks prior to first dose.

• Oral treatment with antimicrobial therapy starting less than two weeks prior to first dose.

• Known human immunodeficiency virus seropositivity.

• Positive serology (unless due to vaccination or passive immunization due to Ig therapy) for hepatitis B.

• Positive serology for hepatitis C based on test at screening.

• Inflammatory bowel disease including Crohn's disease and colitis ulcerosa.

• Inflammatory lung disease including moderate and severe asthma and chronic obstructive pulmonary disease (COPD) requiring chronic medical therapy.

• Ongoing acute or chronic inflammatory skin disease.

• Active ocular surface disease at baseline (based on ophthalmological evaluation).

• History of cicatricial conjunctivitis (as evaluated by an ophthalmologist).