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Clinical Trials/NCT07055594
NCT07055594RecruitingPhase 1

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.

Shine-On Biomedical Co., Ltd.1 site in 1 country76 target enrollmentStarted: July 30, 2025Last updated:
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Interventions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Sponsor
Enrollment
76
Locations
1
Primary Endpoint
Maximum Tolerated Dose (MTD) of SOA101 for Phase I
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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-L
  • •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.

Arms & Interventions

SOA101

Experimental

Intervention: SOA101 (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Maximum observed plasma concentration of SOA101 (Cmax)(Up to end of study visit (90 days after the last dose))
  • Area Under the Curve of SOA101 (AUC)(Up to end of study visit (90 days after the last dose))
  • Half-life of SOA101 (T1/2)(Up to end of study visit (90 days after the last dose))
  • Overall Response Rate (ORR)(Up to end of study visit (90 days after the last dose))

Investigators

Sponsor
Shine-On Biomedical Co., Ltd.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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