Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First in-Human, Consecutive-Cohort, Clinical Trial of BI 1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
- Conditions
- Advanced solid tumorsMedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-503066-74-00
- Lead Sponsor
- Bioinvent International AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 104
Is willing and able to provide signed informed consent for the trial. If the subject does not consent to the genetic testing they may still participate in the trial., Is =18 years of age on the day of signing the informed consent form (ICF)., Has a histologically confirmed advanced/metastatic solid tumor., Has received standard of care and progressed or is intolerant of, or is not eligible to receive standard of care antineoplastic therapy., Has at least 1 measurable disease lesion as defined by RECIST v1.1., Must be willing to provide tumor biopsies as specified in the schedule of assessments unless otherwise discussed and agreed with the Sponsor in case a biopsy cannot be taken for a medical/safety reason. The Screening biopsy must be performed prior to the first dose of BI-1910 (on non previously irradiated lesions only), and at least 4 weeks following the last dose of tumor directed therapy. The biopsy at Screening can be replaced with a formalin fixed archival tumor tissue sample collected from a previous standard of care biopsy, provided that the biopsy was performed after the subject’s last tumor directed therapy and prior to trial entry., Has a life expectancy of =12 weeks., Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., Has adequate organ function as confirmed by laboratory values
Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication. During the Screening period, doses of up to 20 mg/day may be given but the dose must be reduced to 10 mg/day within 7 days prior to the first dose of study treatment. Steroids are allowed as premedication in subjects with allergies to contrast scans., Is a female subject and has the ability to become pregnant (or already pregnant or lactating/breastfeeding). However, those female subjects who have a negative serum or urine pregnancy test up to 72 hours prior to their first dose of study treatment and agree to use a highly effective method of birth control for 4 weeks before entering the trial, during the trial, and for 12 months after their last dose of study treatment (BI 1910 or pembrolizumab), are considered eligible. Highly effective methods of birth control include: a. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: i. Oral ii. Intravaginal iii. Transdermal b. Progestogen-only hormonal contraception associated with inhibition of ovulation: i. Oral ii. Injectable iii. Implantable c. Intrauterine device d. Intrauterine hormone-releasing system e. Bilateral tubal occlusion f. Vasectomized partner (given that the partner is the sole sexual partner of the subject and that the vasectomized partner has received medical assessment of the surgical success). g. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject). Note: A woman of childbearing potential is defined as any female who has experienced menarche, who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), and who is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a documented serum follicle-stimulating hormone level >40 mIU/mL to confirm menopause., Is a male subject with partner(s) of childbearing potential (unless he agrees to use a barrier method of contraception [condom plus spermicidal gel] with the female partner(s) who are using one highly effective method of contraception during the trial and for 12 months after completing treatment). Men with pregnant or lactating partners should be advised to use barrier method contraception (condom plus spermicidal gel) to prevent exposure to the fetus or neonate. All males should refrain from sperm donation for 12 months after last dose of study treatment., Has had major surgery from which the subject has not yet recovered., Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals other than the ones considered adequate for treatment of HBV., Has presence of chronic graft versus host disease., Has had an allogenic tissue/solid organ transplant., Is positive for Human Immunodeficiency Virus (HIV)., Has history of chronic HBV or HCV infections. Note: has a positive hepatitis B antigen/HBV DNA or hepatitis C antibody or RNA. Active hepatitis C is defined by a known positive hepatitis C antibody result and known quantitative hepatitis C virus RNA resul
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method