Overview
The purpose of this study is to determine the safety and tolerability of monotherapy CR-002 and to identify the MTD and/or optimal biologic dose and RP2D(s) in participants with locally advanced or metastatic solid tumors.
Description
The study will initially comprise 2 parts: dose escalation (Part 1) and backfill (Part 2). Population-defined dose optimization (Part 3) and expansion (Part 4) cohorts may be added based on emerging data.
Part 1: The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors.
Part 2: Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee.
All participants will undergo a screening period, a treatment period, a safety follow-up period, and long-term follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, and pharmacokinetic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.
Eligibility
Inclusion Criteria:
- Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Adequate organ function and hematologic reserve based on laboratory parameters
- Have measurable disease defined by RECIST v1.1
- Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy
- Tumor indication specific inclusion criteria:
- Is progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types:
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Gastric/GEJ Cancer
- Biliary Tract Cancer (BTC)
- Esophageal Squamous Cell Carcinoma (ESCC)
- Ovarian Cancer
- Endometrial Carcinoma
- Cervical Cancer
- Non-Small Cell Lung Cancer (NSCLC)
Exclusion Criteria:
- Has malignancies other than disease under study within the past 3 years
- Has not adequately recovered from recent major surgery
- Has ongoing clinically significant toxicity related to prior therapy
- Has known sensitivity to any component of CR-002
- Has received prior treatment with an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload.
- Has active central nervous system (CNS) metastases
- Has a medical or psychological condition that could interfere with study participation, increase risk, or affect interpretation of the study results
- NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
