Mass General - Division of Clinical Research

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Key Eligibility Criteria :

1. Participants must sign a written informed consent form (ICF); and agree to comply
with study requirement

2. Phase 1a (Dose Escalation):

Part A, A-CN, and B: Participants with histologically or cytologically confirmed
unresectable locally advanced or metastatic solid tumor previously treated with
standard systemic therapy or for whom treatment is not available or not tolerated
Note: Only Chinese participants will be eligible for Part A-CN.

Part C: Participant has histologically or cytologically confirmed, locally advanced,
unresectable Stage III Non-small cell lung cancer (NSCLC) suitable for definitive
chemoradiotherapy (CRT)

Part D: Participant with locally advanced, histologically confirmed inoperable
esophageal squamous cell carcinoma (ESCC) suitable for definitive CRT

Phase 1b (Dose Expansion): Participants with histologically or cytologically
confirmed solid tumors of selected types previously treated with standard therapy.

3. Participants must be able to provide formalin-fixed paraffin embedded (FFPE) tumor
tissue sample.

4. Phase 1a Part A, A-CN, B and Phase 1b: ≥ 1 measurable lesion per Response evaluation
criteria in solid tumors (RECIST) v1.1

5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

Key Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

2. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the
specific cancer under investigation in this study and any locally recurring cancer
that has been treated with curative intent

3. Any condition that required systemic treatment with either corticosteroids or other
immunosuppressive medication ≤ 14 days before the first dose of study drug(s).

4. Clinically significant infection requiring systemic therapy ≤ 14 days before the
first dose of study drug(s).

5. Prior exposure to agents with second mitochondria-derived activator of caspases
(SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.