Solid TumorPhase 1SPX-303NCT06259552
A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors
A Phase 1 study testing SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody in people with Solid Tumor and HNSCC, run by SparX Biotech(Jiangsu) Co., Ltd. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, HNSCC, RCC
- What is being tested?
- SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Mar 2024to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Has at least 1 measurable lesion per RECIST 1.1 criteria
- Recovery from previous treatment related adverse events (TRAEs) to allow safety evaluations of SPX-303. Previous TRAEs include adverse drug reactions, and consequences of radiation, surgery, and other therapeutic modalities
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- Adequate hepatic function; bilirubin ≤1.5x upper limit of normal (ULN) (except for patients with Gilbert syndrome: ≤ 3xULN), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver metastases present).
- Adequate renal function as calculated (e.g. Cockroft Gault) creatine clearance (CrCl) ≥ 30 mL/min or 24-hour urine CrCl ≥ 30 mL/min.
- Adequate hematological function: absolute neutrophil count (ANC) ≥1 x 10^9/L; platelets ≥75 x 10^9/L, hemoglobin ≥9 g/dL.
- Patients with well controlled HIV infection (ie CD4+ count >350 cells/uL and viral copies less than 400/mL after at least 4 weeks of ART) are eligible for the trial.
- Adequate coagulation function: INR, PT and aPPT ≤ 1.5x ULN except for patients on anti-coagulation as long as PT, aPPT, or INR are within intended range.
- Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 45% by multi-gated acquisition (MUGA) or echocardiography (ECHO) scan.
- Fridericia-corrected QT interval (QTcF) ≤480 msec.
- Women of childbearing potential must have a negative pregnancy test and must agree to use of 2 different methods of acceptable contraception from screening until 4 months after the last dose of study drug. Acceptable methods of contraception are defined as those that result, alone or in combination, in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, hormonal contraception in combination with a barrier method or abstinence).
- Males who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception (eg, condom with spermicidal foam/gel/film/cream/suppository) from screening until 4 months following the last dose of study drug, in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 4 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy >6 months before signing the ICF.
Who cannot join
- 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.
- History of permanent discontinuation of prior IO therapy due to irAE.
- Prior treatment targeting ILT2 and/or ILT4 or targeting HLA G.
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- Live or live attenuated vaccine ≤ 28days prior to dosing.
- Immunosuppressive systemic medication, except topical corticosteroids or systemic corticosteroids at a dose level of ≤ 10 mg/d of prednisone/prednisolone or equivalent. Note: patients with adrenal insufficiency requiring hormonal replacement may receive higher dose of steroids.
- Prior solid organ or bone marrow transplantation (except cornea transplantation).
- History of clinically significant cardiovascular events (e.g. DVT ≤ 6 months, PE ≤ 12 months, MI or hospitalization for CHF ≤ 12 months, bleeding disorder or bleeding event ≤ 6 months, current clinically significant arrhythmia or unstable angina pectoris, current uncontrolled history of cerebrovascular accident in the past 6 months, current uncontrolled hypertension).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Sam Nussbaum, 855-776-0015
Yujie Zhao, MD PhD
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Selena Venegas, 855-776-0015
Mitesh Borad, MD
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Lucas Hamann, 855-776-0015
Hao Xie, MD PhD
- Recruiting
HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258
Hannah Robertson
Justin Moser, MD
About this study
Official title: A Phase 1, Open-label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an Anti-LILRB2 / PD-L1 Bispecific Antibody SPX- 303 in Patients With Solid Tumors
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.
Read the detailed description
This study is an open-label, dose escalation study of SPX-303 monotherapy to evaluate safety and tolerability, and to identify the MTD or MAD as well as evaluate preliminary anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of various doses of SPX- 303 in patients with measurable disease who have progressed on or after prior therapy and who are not eligible or decline treatment options.
- Conditions
- Solid Tumor, HNSCC, RCC, CRC
- Being tested
- SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody
- Keywords
- Solid Tumor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 AntibodyBiological
Also called SPX-303
SPX- 303 Injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose escalation and expansion study of SPX-303 | Experimental | 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. Receives: Biological: SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody |
| Part 2: Dose expansion study of SPX-303 in specific indications | Experimental | SPX-303 will be administered in specific solid tumor patients to evaluate the preliminary antitumor activity and define the RP2D. Receives: Biological: SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 21 days of Cycle 1
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)
Measured: 3.5 years
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.
Measured: 3-6 months
Part 2: Phase 2 dose (RP2D) determination
RP2D is determined evaluating two dose levels in each specific indications.
Measured: 1-3 years
Secondary outcomes (7)
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.
Measured: 1-3 years
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.
Measured: 1-3 years
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.
Measured: 1-3 years
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.
Measured: 1-3 years
Part 1: Pharmacokinetics (PK)
PK is evaluated using serum concentration of SPX-303.
Measured: 1-3 years
Part 1: Pharmacodynamics (PD)
PD is evaluated using receptor occupancy of SPX-303.
Measured: 1-3 years
Part 2: Preliminary anti-tumor activity at RP2D
Preliminary anti-tumor activity is evaluated in RP2D cohorts.
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start20 Mar 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part 1: After the first dose escalation cohort of one patient, further dose escalation cohorts will recruit patients to receive SPX-303 in a 3+3 design; cohorts will be expanded in the event of a DLT. A safety dose expansion of up to 10 patients will confirm the MTD or MAD. Part 2: Once the MTD or MAD has been established, the RP2D and preliminary efficacy will be determined by evaluating two dose levels in specific indications.
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SparX Biotech(Jiangsu) Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guidong Zhu, Study chair, SparX Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259552
- Sponsor's protocol ID
- PROT-CR-CP23001
- Acronym
- SPX-303
- Status last verified
- Sep 2024
- First submitted
- 20 Jan 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an Anti-LILRB2 / PD-L1 Bispecific Antibody SPX- 303 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT06259552
- Acronym / sponsor ID
- SPX-303 / PROT-CR-CP23001
- Conditions
- Solid Tumor, HNSCC, RCC, CRC
- Keywords
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- SparX Biotech(Jiangsu) Co., Ltd.University, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an open-label, dose escalation study of SPX-303 monotherapy to evaluate safety and tolerability, and to identify the MTD or MAD as well as evaluate preliminary anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of various doses of SPX- 303 in patients with measurable disease who have progressed on or after prior therapy and who are not eligible or decline treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1: After the first dose escalation cohort of one patient, further dose escalation cohorts will recruit patients to receive SPX-303 in a 3+3 design; cohorts will be expanded in the event of a DLT. A safety dose expansion of up to 10 patients will confirm the MTD or MAD. Part 2: Once the MTD or MAD has been established, the RP2D and preliminary efficacy will be determined by evaluating two dose levels in specific indications.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose escalation and expansion study of SPX-303 | Experimental | Biological: SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 AntibodyDose 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. |
| Part 2: Dose expansion study of SPX-303 in specific indications | Experimental | Biological: SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 AntibodySPX-303 will be administered in specific solid tumor patients to evaluate the preliminary antitumor activity and define the RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Has at least 1 measurable lesion per RECIST 1.1 criteria
Key exclusion criteria (10 listed)
- 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.
- History of permanent discontinuation of prior IO therapy due to irAE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 AntibodyAlso: SPX-303SPX- 303 Injection | Biological | Part 1: Dose escalation and expansion study of SPX-303, Part 2: Dose expansion study of SPX-303 in specific indications |
Primary outcome
Part 1: Number of participants with dose limiting toxicities (DLTs)
Time frame: 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)
Time frame: 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 2
Time frame: 3-6 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) determination
Time frame: 1-3 years
RP2D is determined evaluating two dose levels in each specific indications.
7 secondary outcomes
Part 1: Objective Response Rate (ORR)
Time frame: 1-3 years
Part 1: Duration of Response (DOR)
Time frame: 1-3 years
Part 1: Disease Control Rate (DCR)
Time frame: 1-3 years
Part 1: Progression-free Survival (PFS)
Time frame: 1-3 years
Part 1: Pharmacokinetics (PK)
Time frame: 1-3 years
Part 1: Pharmacodynamics (PD)
Time frame: 1-3 years
Part 2: Preliminary anti-tumor activity at RP2D
Time frame: 1-3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guidong Zhu study chair
SparX Biotech
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPX- 303 Injection, a bispecific anti-LILRB2 / anti-PD-L1 Antibody in people with Solid Tumor and HNSCC, run by SparX Biotech(Jiangsu) Co., Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SparX Biotech (847-739-6251, SPX-303@sparxbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of participants with dose limiting toxicities (DLTs) (time frame: First 21 days of Cycle 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.