Solid Tumors
Conditions
Brief summary
The investigational drug, SOA101, is a nanobody-based trispecific antibody T cell engager targeting PD-L1/HLA-G/CD3. This is a Phase I/IIa study including dose-escalation, dose optimization and dose expansion parts to exam safety, tolerability, pharmacokinetics, immunogenecity and efficacy of SOA101 on advanced or metastatic solid tumor treatment.
Interventions
DRUGSOA101
Participants will receive SOA101. The RP2D will be determined based on the results of the Phase I study. During the dose expansion phase, participants will receive SOA101 at the RP2D regimen.
Sponsors
Shine-On Biomedical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged ≥ 18 years old. 2. Subjects with locally advanced, or metastatic solid tumors confirmed histologically or cytologically as one of the following cancer types for whom no suitable alternative standard-of-care therapy exists: 1. Non-small cell lung cancer (NSCLC); 2. Ovarian cancer (OC); 3. Head and neck carcinoma (H&N); 4. Breast cancer (BC); 5. Colorectal cancer (CRC). 3. Pathologically confirmed combined positive score (CPS) with ≥ 1% expression of PD-L1. 4. At least one measurable lesion 5. Adequate organ function 6. Female subject must either not be of childbearing potential or a negative pregnancy test 7. Non-vasectomized male subjects must practice highly effective contraception
Exclusion criteria
1. Active bacterial, fungal, viral OR atypical infection requiring systemic medication. 2. Received any investigational drug within 4 weeks before screening. 3. Confirmed active HIV (without controlled disease on HAART), HBV, or HCV infection. 4. Symptomatic, unstable central nervous system malignancy OR metastasis 5. Have received organ or tissue transplantation or allogeneic cell therapies. 6. Non-adequate cardiac function 7. Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) of SOA101 for Phase I | from start until 3 months after the last dosing |
| Objective Response Rate (ORR) of SOA101 for Phase IIa | from start until 3 months after the last dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of SOA101 (AUC) | Up to end of study visit (90 days after the last dose) | Pharmacokinetics (PK) parameters |
| Maximum observed plasma concentration of SOA101 (Cmax) | Up to end of study visit (90 days after the last dose) | Pharmacokinetics (PK) parameters |
| Half-life of SOA101 (T1/2) | Up to end of study visit (90 days after the last dose) | Pharmacokinetics (PK) parameters |
| Overall Response Rate (ORR) | Up to end of study visit (90 days after the last dose) | Evaluation of anti-tumor activity of SOA101 |
Countries
Taiwan
Contacts
Primary ContactJennifer Ho
Backup ContactOscar Yang
Outcome results
None listed