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

ConditionsSolid TumorHNSCCRCCCRC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSparX Biotech(Jiangsu) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females ≥18 years of age who comprehend, are not incarcerated, are willing and able to provide consent by signing an ICF, and able to comply with scheduled visits, treatment schedule, and laboratory tests, including other requirements for the study

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Disqualifiers

History of prior malignancy, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast, prostate) for which the patient has been disease free for at least 3 years. Prostate cancer patients on active surveillance are eligible.

Active brain or leptomeningeal metastasis. Except patients with known brain metastases if they have been treated and MRI shows no evidence of progression for at least 8 weeks and require less than 10 mg/day prednisone/prednisolone or equivalent.

Treatment with anti neoplastic therapy ≤ 28 days or ≤ 5× elimination half life, whichever is shorter, before the first dose of study drug.

Major surgery requiring general anesthesia ≤ 28 days prior to dosing.

Trial design

Design model

Sequential

Treatments tested in this trial

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

    Biological/Vaccine

    SPX- 303 Injection

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose escalation and expansion study of SPX-303Experimental treatment 1 intervention
Group B: Part 2: Dose expansion study of SPX-303 in specific indicationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
First 21 days of Cycle 1
2

Part 1: Treatment-Related Adverse Events (TRAE)

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)

Time frame
3.5 years
3

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

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.

Time frame
3-6 months
4

Part 2: Phase 2 dose (RP2D) determination

RP2D is determined evaluating two dose levels in each specific indications.

Time frame
1-3 years

Secondary outcomes

1

Part 1: Objective Response Rate (ORR)

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.

Time frame
1-3 years
2

Part 1: Duration of Response (DOR)

DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v5.0 or death due to any cause, whichever occurs first.

Time frame
1-3 years
3

Part 1: Disease Control Rate (DCR)

DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per CTCAE v5.0.

Time frame
1-3 years
4

Part 1: Progression-free Survival (PFS)

PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v5.0 or death which occurs first.

Time frame
1-3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SparX Biotech(Jiangsu) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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