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Tests treatment safety and results for Solid Tumors
Official title A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07055594
What this study is testing
What is SOA101?
SOA101 is an investigational medicine, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people aged ≥ 18 years old.
- people with locally advanced, or metastatic solid tumors confirmed histologically or cytologically as one of the following cancer types for whom no...
- Non-small cell lung cancer (NSCLC);
- Ovarian cancer (OC);
- Head and neck carcinoma (H\&N);
You likely can't join if
- 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
See the full eligibility criteria
- Male or female people aged ≥ 18 years old.
- people 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 people must practice highly effective contraception
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taichung, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taichung, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.