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

Trial Summary

What is the purpose of 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.

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.

What makes the drug SPX-303 unique for treating solid tumors?

SPX-303 is unique because it is a humanized antibody targeting Semaphorin 4D, which is different from traditional chemotherapy drugs that target rapidly dividing cells. This approach may offer a novel mechanism of action by interfering with tumor growth and spread. ^{1 2 3 4 5}

Research Team

Guidong Zhu

Principal Investigator

SparX Biotech

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2018]

3. United States 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin (doxil): reduced clinical cardiotoxicity in patients reaching or exceeding cumulative doses of 500 mg/m2. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Weekly paclitaxel with concurrent intensity-modulated radiotherapy for nasopharyngeal carcinoma: outcomes of a tolerance trial]. [2015]