Clinical trial · Interventional
A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects 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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SOA101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SOA101
- interventionNames
- Drug: SOA101
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of SOA101 for Phase I
- timeFrame
- from start until 3 months after the last dosing
- measure
- Objective Response Rate (ORR) of SOA101 for Phase IIa
- timeFrame
- from start until 3 months after the last dosing
Secondary outcomes (4)
- measure
- Area Under the Curve of SOA101 (AUC)
- timeFrame
- Up to end of study visit (90 days after the last dose)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTLin YC, Chen MC, Huang SW, Chen Y, Ho JH, Lin FY, Tan XT, Chiang HC, Huang CC, Tu CY, Cho DY, Chiu SC. Targeting Dual Immune Checkpoints PD-L1 and HLA-G by Trispecific T Cell Engager for Treating Heterogeneous Lung Cancer. Adv Sci (Weinh). 2024 Nov;11(41):e2309697. doi: 10.1002/advs.202309697. Epub 2024 Sep 5. PMID 39234811