SPX-303 for Solid Tumors

(SPX-303 Trial)

Recruiting at 3 trial locations

Overseen By SparX Biotech

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SparX Biotech(Jiangsu) Co., Ltd.

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Active brain metastasis, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

232 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SPX-303 for individuals with solid tumors, a type of cancer that forms in solid organs like the lungs or liver. The study aims to determine the treatment's safety and optimal dosage. It targets patients who have exhausted other therapies without success and have no remaining treatment options. Those with advanced or metastatic solid tumors, whose cancer has progressed after other treatments, might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive SPX-303, aiding researchers in understanding how the treatment functions in humans.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have had anti-neoplastic therapy within 28 days before the first dose of the study drug and should not be on immunosuppressive systemic medication, except for certain low-dose corticosteroids.

Is there any evidence suggesting that SPX-303 is likely to be safe for humans?

Earlier research found SPX-303 to be generally safe for patients with solid tumors. Among 42 patients, most side effects were mild, such as nausea and tiredness. While some side effects occurred, they were usually not serious. As this treatment remains in early testing stages, researchers closely monitor and update safety and side effect information as more data becomes available. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SPX-303 because it offers a novel approach to treating solid tumors. Unlike traditional chemotherapy, which targets all rapidly dividing cells, SPX-303 is designed to specifically target and disrupt tumor cells, potentially reducing side effects. The treatment is administered intravenously every three weeks, allowing for a more controlled and potentially effective dosing schedule. This targeted method may enhance the antitumor activity, giving hope for better outcomes in patients who have not responded to existing treatment options.

What evidence suggests that SPX-303 might be an effective treatment for solid tumors?

Studies have shown that SPX-303 can significantly slow tumor growth in lab tests. SPX-303 is a special antibody that targets two proteins, LILRB2 and PD-L1, to help the immune system better locate and attack cancer cells. Early research suggests that blocking these proteins might enhance the effectiveness of other cancer treatments. Similar research has demonstrated that targeting these pathways can improve current therapies for solid tumors. Although SPX-303 is a newer treatment, these findings indicate it could be promising for patients with solid tumors. Participants in this trial will receive SPX-303 in different phases to evaluate its effectiveness and determine the optimal dose. ^{1 4 5 6 7}

Who Is on the Research Team?

Guidong Zhu

Principal Investigator

SparX Biotech

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Fridericia-corrected QT interval (QTcF) ≤480 msec

Has at least 1 measurable lesion per RECIST 1.1 criteria

I have recovered from side effects of my previous cancer treatments.

Exclusion Criteria

I've had cancer before, but I've been cancer-free for 3 years, except for certain skin cancers or if I'm being closely monitored for prostate cancer.

My brain cancer is stable, I've been treated, and I'm on low-dose steroids.

I haven't had cancer treatment in the last 28 days or 5 half-lives of the drug, whichever is shorter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

SPX-303 is administered intravenously every 3 weeks to determine the maximum tolerated dose or maximum accepted dose

3-6 months

Every 3 weeks

Dose Expansion

SPX-303 is administered at the chosen dose level to evaluate preliminary anti-tumor activity

1-3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-3 years

What Are the Treatments Tested in This Trial?

Interventions

• SPX-303

Trial Overview

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.

How Is the Trial Designed?

Group I: Part 2: Dose expansion study of SPX-303 in specific indications Experimental Treatment 1 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-303 Experimental Treatment 1 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.

SPX-303 is already approved in United States for the following indications:

Approved in United States as SPX-303 for:

• Solid Tumors

Who Is Running the Clinical Trial?

SparX Biotech(Jiangsu) Co., Ltd.

Lead Sponsor

Trials

2

Recruited

230+

Published Research Related to This Trial

VX15/2503 was well tolerated in a study of 42 patients with advanced solid tumors, with most side effects being mild (grade 1 or 2), such as nausea and fatigue, indicating a favorable safety profile.

The treatment showed promising antitumor activity, with one patient achieving a partial response and 45.2% of patients maintaining stable disease for at least 8 weeks, suggesting that VX15/2503 may enhance immune response against tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Pharmacokinetics, and Pharmacodynamics of a Humanized Anti-Semaphorin 4D Antibody, in a First-In-Human Study of Patients with Advanced Solid Tumors. Patnaik, A., Weiss, GJ., Leonard, JE., et al.[2022]

In a phase II trial involving 29 women with platinum-resistant or refractory epithelial ovarian cancer, Lipo-Dox demonstrated an overall response rate of 23.1%, with a median response duration of 11.6 weeks, indicating its efficacy in this challenging patient population.

The treatment was generally well-tolerated, with most side effects being mild (Grade 1/2), including hand-foot skin reactions (4.5%) and nausea (14.2%), suggesting a favorable safety profile for Lipo-Dox in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin (Lipo-Dox) for platinum-resistant or refractory epithelial ovarian carcinoma: a Taiwanese gynecologic oncology group study with long-term follow-up. Chou, HH., Wang, KL., Chen, CA., et al.[2018]

In a phase I study involving 43 patients with advanced solid tumors, MEDI-573 demonstrated a favorable safety profile with no dose-limiting toxicities and only one case of treatment-related hyperglycemia.

While MEDI-573 did not lead to any partial or complete responses in the tumors, 13 out of 39 evaluable patients showed stable disease, indicating some preliminary antitumor activity in a heavily pretreated population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I dose-escalation study of MEDI-573, a bispecific, antiligand monoclonal antibody against IGFI and IGFII, in patients with advanced solid tumors. Haluska, P., Menefee, M., Plimack, ER., et al.[2021]

The maximum tolerated dose (MTD) of paclitaxel when used weekly with concurrent intensity-modulated radiotherapy (IMRT) for locally advanced nasopharyngeal carcinoma (NPC) is determined to be 50 mg/(m²·week), with mucositis identified as the dose-limiting toxicity (DLT).

In a study involving 15 patients, all achieved complete clinical remission at the local site, and 93.3% achieved complete remission at the regional site, indicating that this treatment combination is highly effective for NPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Weekly paclitaxel with concurrent intensity-modulated radiotherapy for nasopharyngeal carcinoma: outcomes of a tolerance trial]. Chen, CY., Lu, TX., Zhao, C., et al.[2015]

In a study of 42 patients receiving cumulative doses of pegylated liposomal doxorubicin (doxil) exceeding 500 mg/m2, none developed clinical congestive heart failure, indicating a favorable safety profile for higher doses compared to traditional doxorubicin.

While five patients experienced a drop in left ventricular ejection fraction (LVEF), the overall risk of cardiomyopathy appears significantly lower with doxil, even in patients previously treated with doxorubicin, suggesting that doxil may be a safer option for patients with solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin (doxil): reduced clinical cardiotoxicity in patients reaching or exceeding cumulative doses of 500 mg/m2. Safra, T., Muggia, F., Jeffers, S., et al.[2022]

Citations

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SPX-303 for Solid Tumors

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A Study of SPX-303, a Bispecific Antibody Targeting ...

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 ...

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aacrjournals.org/cancerres/article/84/6_Supplement/2729/738781/Abstract-2729-Discovery-and-characterization-of

Abstract 2729: Discovery and characterization of LILRB2XPD ...

In vivo experiments reveal that SPX-303 significantly inhibits tumor growth. Collectively, these results support SPX-303 as a novel therapeutic ...

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pmc.ncbi.nlm.nih.gov/articles/PMC12453052/

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These results demonstrated, for the first time, the great potential of ILT4 blockade in improving PD-1 inhibitor efficacy in solid tumours.

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SparX Biopharmaceutical Announces FDA Greenlight for ...

SPX-303 is meticulously designed to dismantle this barrier, empowering the immune system to discern and fervently annihilate malignant cells, ...

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mayo.edu/research/clinical-trials/cls-20570802

A Study of SPX-303, a Bispecific Antibody Targeting ...

The purpose of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / PD-L1 bispecific antibody SPX- 303 in patients with ...

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SPX-303 - Drug Targets, Indications, Patents

... SPX- 303 in Patients With Solid Tumors. 100 Clinical Results ... This study aims to evaluate SPX-303's safety, tolerability, and ...