A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
76 (estimated)
Sponsor
Shine-On Biomedical Co., Ltd. · Industry
Who this trial is looking for
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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.
Trial Locations
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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 lu…
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.
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