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Monoclonal Antibodies

Part 1: Dose escalation and expansion study of SPX-303 for Colorectal Cancer (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

SPX-303 Trial 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.Check my eligibility

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.See study design

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.

SPX-303 Trial 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.

SPX-303 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Part 1: Disease Control Rate (DCR)

Part 1: Duration of Response (DOR)

Part 1: Objective Response Rate (ORR)

+4 more

Side effects data

From 2021 Phase 2 trial • 22 Patients • NCT03019640

100%

Nausea

100%

White blood cell decreased

100%

Lymphocyte count decreased

100%

Fever

100%

Platelet count decreased

100%

Anemia

100%

Neutrophil count decreased

95%

Diarrhea

82%

Hyperglycemia

77%

Mucositis oral

77%

Fatigue

64%

Sinus tachycardia

59%

Hypotension

59%

Anorexia

55%

Hypophosphatemia

55%

Constipation

55%

Edema limbs

55%

Rash maculo-papular

50%

Headache

45%

Hypoalbuminemia

45%

Hypocalcemia

45%

Alanine aminotransferase increased

41%

Hypokalemia

41%

Dizziness

36%

Hyponatremia

36%

Anxiety

32%

Investigations

32%

Insomnia

32%

Vomiting

32%

Chills

32%

Cough

32%

Febrile neutropenia

32%

Hypertension

27%

Pain

27%

Alkaline phosphatase increased

27%

Aspartate aminotransferase increased

23%

Infections and infestations

23%

Hypomagnesemia

23%

Dysphagia

23%

Arthralgia

23%

Esophagitis

23%

Hiccups

18%

Dehydration

18%

Hypoxia

18%

Abdominal pain

18%

Allergic rhinitis

18%

Dyspnea

18%

Generalized muscle weakness

18%

Hemorrhoids

14%

Infusion related reaction

14%

INR increased

14%

Immune system disorders

14%

Bloating

14%

Paresthesia

14%

Pleural effusion

14%

Dyspepsia

14%

Hypermagnesemia

14%

Rectal pain

Upper respiratory infection

Sore throat

Blood bilirubin increased

Bone pain

Cholesterol high

Creatinine increased

Nasal congestion

Papulopustular rash

Arthritis

Back pain

Dry skin

Dysgeusia

Flushing

General disorders and administration site conditions

Hypernatremia

Hyperuricemia

Non-cardiac chest pain

Renal and urinary disorders

Skin ulceration

Hypoglycemia

Lymph node pain

Tremor

Hypothyroidism

Thromboembolic event

Urinary tract pain

Lymphocyte count increased

Myalgia

Urinary tract infection

Urinary frequency

Lung infection

Weight gain

Vascular disorders

Lung

Eye disorders

Gastroesophageal reflux disease

Mucosal infection

Metabolism and nutrition disorders

Musculoskeletal and connective tissue disorder

Peripheral motor neuropathy

Prostatic obstruction

Pulmonary edema

Rash acneiform

Respiratory failure

Acute kidney injury

Ear pain

Edema face

Encephalopathy

Endocrine disorders

Atelectasis

Atrial fibrillation

Bladder infection

Epistaxis

Flatulence

Gastrointestinal pain

Hematuria

Hemorrhoidal hemorrhage

Hypercalcemia

Neck pain

Nervous system disorders

Pain in extremity

Restlessness

Sinus bradycardia

Sinusitis

Skin and subcutaneous tissue disorder

Skin hyperpigmentation

Ileus

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)

SPX-303 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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

1 Previous Clinical Trials

27 Total Patients Enrolled

Guidong ZhuStudy ChairSparX Biotech

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this clinical trial at the moment?

"As per the details on clinicaltrials.gov, recruitment for this specific trial is presently closed. The initial posting was on February 1st, 2024, with the latest update noted on February 6th, 2024. Despite this particular study not actively seeking participants currently, it's worth noting that there are a substantial number of 2767 other trials open to enrollment at present."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The primary aim of this investigation will be observed over a span of approximately 3.5 years and is focused on Part 1: Identifying participants experiencing dose-limiting toxicities (DLTs). Supplementary endpoints encompass Part 1: Assessment of Pharmacodynamics (PD), ascertained through SPX-303 receptor occupancy evaluation, Part 1: Evaluation of Progression-free Survival (PFS) defined as the duration from initial treatment to either disease progression per CTCAE v5.0 or mortality - whichever comes first, and Part 2: Preliminary assessment of anti-tumor effects at Recommended Phase 2 Dose (RP"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06259552.

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