A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors (NbTAST-01)

Shine-On Biomedical Co., Ltd.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: SOA101

Study type: Interventional

Funder types: Industry

Identifiers

NCT07055594

SOA101-CL-Proto-01

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

SOA101

Experimental group

Treatment:

Drug: SOA101