Overview
The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.
Description
Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of solid tumor
- Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies
- Radiologically or clinically determined progressive disease during or after most recent line of therapy
- Measurable disease per RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate hematological and biochemical parameters
- A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate
- A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment
Exclusion Criteria
- Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
- Prior treatment with an ADC containing a topoisomerase I inhibitor payload
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
- Other malignancy
- Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
- Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment
- Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1
- Clinically significant cardiovascular disease
- Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2
- Current active liver disease due to hepatitis B or hepatitis C
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis
