A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SOA101.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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
- Drug SOA101
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.
Primary outcome measures
- Maximum Tolerated Dose (MTD) of SOA101 for Phase I [Time frame: from start until 3 months after the last dosing]
- Objective Response Rate (ORR) of SOA101 for Phase IIa [Time frame: from start until 3 months after the last dosing]
Secondary outcome measures (4)
- Area Under the Curve of SOA101 (AUC) [Time frame: Up to end of study visit (90 days after the last dose)]
- Maximum observed plasma concentration of SOA101 (Cmax) [Time frame: Up to end of study visit (90 days after the last dose)]
- Half-life of SOA101 (T1/2) [Time frame: Up to end of study visit (90 days after the last dose)]
- Overall Response Rate (ORR) [Time frame: Up to end of study visit (90 days after the last dose)]
Eligibility criteria
Inclusion criteria
- Male or female subjects aged ≥ 18 years old.
- 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:
- Non-small cell lung cancer (NSCLC);
- Ovarian cancer (OC);
- Head and neck carcinoma (H\&N);
- Breast cancer (BC);
- Colorectal cancer (CRC).
- Pathologically confirmed combined positive score (CPS) with ≥ 1% expression of PD-L1.
- At least one measurable lesion
- Adequate organ function
- Female subject must either not be of childbearing potential or a negative pregnancy test
- Non-vasectomized male subjects must practice highly effective contraception
Exclusion criteria
- Active bacterial, fungal, viral OR atypical infection requiring systemic medication.
- Received any investigational drug within 4 weeks before screening.
- Confirmed active HIV (without controlled disease on HAART), HBV, or HCV infection.
- Symptomatic, unstable central nervous system malignancy OR metastasis
- Have received organ or tissue transplantation or allogeneic cell therapies.
- Non-adequate cardiac function
- Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- China Medical University Hospital — Taichung
Publications
- Lin 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
Identifiers
NCT: NCT07055594 · SOA101-CL-Proto-01