A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
SparX Biotech(Jiangsu) Co., Ltd.
Study ID
NCT06259552
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody — BIOLOGICAL
    SPX- 303 Injection

Study Details

Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.

Key Dates

Start date
Mar 20, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
232 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose escalation and expansion study of SPX-303
    Dose Escalation Phase: SPX-303 will be administered intravenously (IV) every 3 weeks (Q3W). Participants enroll with measurable disease who have progressed on or after prior therapy and who are not eligible or decline treatment options. Dose Expansion phase: SPX-303 will be administered at the dose level chosen during the escalation phase in the dose expansion cohort.
  • Experimental: Part 2: Dose expansion study of SPX-303 in specific indications
    SPX-303 will be administered in specific solid tumor patients to evaluate the preliminary antitumor activity and define the RP2D.

Primary Outcome Measure

Part 1: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: First 21 days of Cycle 1 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Selena Venegas
855-776-0015
Mitesh Borad, MD (PRINCIPAL_INVESTIGATOR)
HonorHealth Research and Innovation InstituteScottsdaleArizona85258
Hannah Robertson
Justin Moser, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic FloridaJacksonvilleFlorida32224
Sam Nussbaum
855-776-0015
Yujie Zhao, MD PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Lucas Hamann
855-776-0015
Hao Xie, MD PhD (PRINCIPAL_INVESTIGATOR)

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