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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• China Medical University Hospital
  Taichung, Taiwan Recruiting

Study contacts

• Study coordinator: Jennifer Ho
• Email: rd005@shineon-bio.com
• Phone: +886423272888

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BA1203 in advanced solid tumors: safety and early signs of activity

  This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.

  Recruiting Phase 1 Shandong Boan Biotechnology Co., Ltd · Beijing · NCT07876609

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• REC-7735 for PIK3CA-H1047R-mutant solid tumors

  This study tests REC-7735 in people with unresectable, locally advanced, or metastatic solid tumors that carry the PIK3CA-H1047R mutation.

  Recruiting at 3 sites Phase 1/2 Recursion Pharmaceuticals Inc. · Grand Rapids, Michigan and 2 other locations · NCT07819136

• Preferences of physicians and patients for cell therapies in advanced solid tumors

  This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07813000

• HP007 monotherapy for relapsed or advanced solid tumors

  This study tests HP007 as a standalone treatment in adults with hard-to-treat solid tumors to see if it is safe and tolerable and to look for early signs of activity.

  Recruiting Phase 1 Parr Biotechnology (Hebei) Co., Ltd. · Changchun, Jilin · NCT07800936

• ONO-7429 in advanced or recurrent solid tumors

  This small early-phase study tests whether ONO-7429 is tolerable and safe in adults with unresectable advanced or recurrent solid tumors who have tried other treatments.

  Recruiting at 10 sites Phase 1 Ono Pharmaceutical Co., Ltd. · Kashiwa, Chiba and 9 other locations · NCT07787208

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.