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Monoclonal Antibodies

SPX-303 for Solid Tumors (SPX-303 Trial)

Phase 1

Recruiting

Research Sponsored by SparX Biotech(Jiangsu) Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy

Patients who have progressed on or after prior therapy and who are not eligible for available treatment options

Must not have

Major surgery requiring general anesthesia ≤ 28 days prior to dosing

History of permanent discontinuation of prior IO therapy due to irAE

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SPX-303 in patients with solid tumors. The first part of the study will focus on finding the right dose of the drug and ensuring it is safe.

Who is the study for?

This trial is for individuals with certain solid tumors, including colorectal cancer, head and neck squamous cell carcinoma, and renal cell carcinoma. Participants should have a measurable disease that has progressed after treatment or be untreatable with standard therapies.

What is being tested?

The study tests SPX-303 Injection, targeting two molecules: LILRB2 and PD-L1. The first part involves finding the right dose while checking safety; the second part focuses on how well it works in specific cancers at this dose.

What are the potential side effects?

Potential side effects of SPX-303 may include immune-related reactions due to dual-targeting of LILRB2/PD-L1, typical infusion-related symptoms like fever or chills, fatigue, skin issues, and possibly changes in liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread and confirmed by lab tests.

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My condition worsened after previous treatments and I have no other treatment options.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My liver tests are within the required range.

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My kidney function is good, with a creatinine clearance rate of at least 30 mL/min.

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My blood counts meet the required levels for neutrophils, platelets, and hemoglobin.

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My blood clotting tests are within the normal range, or controlled if I'm on blood thinners.

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My heart pumps well, with an ejection fraction of 45% or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery within the last 4 weeks.

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I had to stop a previous immunotherapy because of severe side effects.

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I have received treatments targeting ILT2, ILT4, or HLA G.

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I have had a solid organ or bone marrow transplant, but not a cornea transplant.

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I haven't had major heart or blood vessel problems in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Number of participants with dose limiting toxicities (DLTs)

Part 1: Potential Phase 2 dose (RP2D) to be further evaluated in Part 2

Part 1: Treatment-Related Adverse Events (TRAE)

+1 more

Secondary study objectives

Part 1: Disease Control Rate (DCR)

Part 1: Duration of Response (DOR)

Part 1: Objective Response Rate (ORR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose expansion study of SPX-303 in specific indicationsExperimental Treatment1 Intervention

SPX-303 will be administered in specific solid tumor patients to evaluate the preliminary antitumor activity and define the RP2D.

Group II: Part 1: Dose escalation and expansion study of SPX-303Experimental Treatment1 Intervention

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.

0 / 13Eligibility criteria met