SOA101 safety and early effectiveness in adults with advanced solid tumors.

A Phase I/IIa Dose-escalation, Dose-optimization and Dose Expansion Study to Evaluate the Safety and Preliminary Efficacy of Tri-specific Antibody (SOA101) in Subjects With Advanced Solid Tumors.

This will test SOA101, a nanobody-based trispecific antibody that engages T cells, to see if it's safe and helps adults with advanced or metastatic solid tumors that express PD-L1.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shine-On Biomedical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Taichung)
• Trial ID: NCT07055594 on ClinicalTrials.gov

What this trial studies

This Phase 1/2a study uses dose-escalation, dose-optimization, and dose-expansion stages to characterize SOA101, a nanobody-based trispecific antibody targeting PD-L1, HLA-G, and CD3 to recruit T cells to tumors. The trial's main goals are to define safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity. Eligible adults have advanced or metastatic NSCLC, ovarian, head and neck, breast, or colorectal cancer with PD-L1 CPS ≥1% and at least one measurable lesion. Participants receive SOA101 at escalating and optimized doses with serial labs, imaging, and immune/PK monitoring at China Medical University Hospital (Taichung).

Who should consider this trial

Good fit: Adults (≥18) with advanced or metastatic NSCLC, ovarian, head and neck, breast, or colorectal cancer whose tumors have PD-L1 CPS ≥1%, who have at least one measurable lesion, adequate organ function, and no suitable standard-of-care alternatives are the intended participants.

Not a fit: Patients with active uncontrolled bacterial, fungal, viral or atypical infections, recent investigational drug exposure, uncontrolled HIV, or tumors with PD-L1 CPS <1% are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, SOA101 could provide a new immunotherapy option that activates patients' T cells to attack PD-L1–expressing solid tumors.

How similar studies have performed: Other bispecific and multispecific T-cell engagers have shown promising signals in early-phase trials, but trispecific agents combining PD-L1/HLA-G/CD3 like SOA101 are novel and less tested in humans.

Eligibility criteria

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.

Where this trial is running

Taichung

• China Medical University Hospital — Taichung, Taiwan (Recruiting)

Study contacts

• Study coordinator: Jennifer Ho

Conditions Solid Tumors