A Study of SPX-303 for Solid Tumors
This study is testing SPX-303, a special type of antibody called a bispecific antibody, in people with advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), and colorectal cancer (CRC). SPX-303 works by targeting two specific proteins, LILRB2 and PD-L1, which are involved in how cancer grows and how the immune system responds. The main goals are to find a safe dose of SPX-303, understand its side effects, and see if it helps shrink tumors. You might be able to join if you are at least 18 years old, have a solid tumor that has progressed after previous treatments, and are not eligible for or have declined other treatment options. The study is currently recruiting 232 participants.
- Study design
- This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It involves increasing doses of SPX-303 to find the best dose.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track treatment-related side effects for up to 3.5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors
At a glance
Conditions
Where it's being run
4 sites across 3 statesStudy leadership
- Guidong Zhu · STUDY_CHAIR · SparX Biotech
Who to contact
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What this trial measures
- Part 1: Number of participants with dose limiting toxicities (DLTs)First 21 days of Cycle 1
A DLT is defined as the clinically significant TRAE(treatment-related adverse events) or abnormal laboratory values assessment during the first 21 days of Cycle 1 and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.
- Part 1: Treatment-Related Adverse Events (TRAE)3.5 years
Treatment related adverse events (TRAEs) by seriousness per CTCAE v. 5.0. as well as tolerability (TRAEs leading to discontinuation, TRAEs leading to dose delays, duration of TRAEs, and semi-quantitative assessments of TRAE treatments)
- Part 1: Potential Phase 2 dose (RP2D) to be further evaluated in Part 23-6 months
Up to 10 patients will be evaluated for safety and tolerability at maximum tolerated dose/maximum accpeted dose or a lower, already cleared dose level.
- Part 2: Phase 2 dose (RP2D) determination1-3 years
RP2D is determined evaluating two dose levels in each specific indications.