Overview
The primary objective of this study is to:
- Evaluate the safety and tolerability of AMG 305 in adult participants
- Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
- Determine the recommended phase 2 dose (RP2D)
Eligibility
Key Inclusion Criteria:
Pre-screening:
- Participant has provided informed consent prior to initiation of any pre screening study specific activities/procedures.
- Participants with histologically or cytologically documented solid tumor diseases expressing cadherin-3 and mesothelin (by mRNA in the Cancer Genome Atlas Program [TCGA] database), including CRC, NSCLC, mesothelioma, pancreatic cancer, gastric cancer, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer
Clinical study:
- Participant has provided inform consent to the main study prior to initiation of any study specific activities/procedures
- Male or female participants age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Participants with histologically or cytologically documented solid tumor diseases, including CRC, NSCLC, mesothelioma, pancreatic cancer, GC, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy
- For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study
- Life expectancy > 3 months
- Adequate organ function
Key Exclusion Criteria:
- Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
- History of other malignancy within the past 2 years
- Ongoing or active infection
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Known interstitial lung disease
- Positive test for human immunodeficiency virus (HIV)
- Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
- Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors (TKI) within 4 weeks or 5 half lives (whichever is longer) of administration of a first dose of study treatment; immunotherapies/monoclonal antibodies within 3 weeks of administration of a first dose of study treatment.
- Has had a major surgery within 4 weeks of administration of a first dose of study treatment
- Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease)
- Live and/or live-attenuated vaccines received within 28 days (or longer, if required locally) prior to the first dose of AMG 305
- Currently receiving treatment in another investigational device or drug study
- Female participants of childbearing potential or male participants unwilling to use protocol specified method of contraception
- Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant while on study
- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion