APL-101 for Lung Cancer
(SPARTA Trial)
Recruiting in Palo Alto (17 mi)
+110 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Apollomics Inc.
Must be taking: EGFR inhibitors
Must not be taking: QTc risk drugs
Disqualifiers: Uncontrolled infection, Heart disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing APL-101, a new drug, on patients with specific genetic changes in their cancer. These patients often don't respond to typical treatments. The drug aims to block a protein that helps cancer cells grow and spread.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications with known QTc risk and strong CYP3A4 inducers or inhibitors at least 5 half-lives before starting the study drug. If these medications can be safely replaced with alternatives, you may still qualify for the trial.
What data supports the effectiveness of the drug APL-101 (Vebreltinib) for lung cancer?
The research on apatinib, a drug similar to APL-101, shows it can be effective for treating advanced non-small cell lung cancer, especially after other treatments have failed. This suggests that APL-101 might also be effective for lung cancer.
12345Eligibility Criteria
Adults with various cancers, including lung cancer with specific genetic changes (c-Met EXON 14 skip mutations), who have acceptable organ function and a life expectancy of at least 3 months. They must not be planning major surgery soon, can provide a tumor sample, and women should not be pregnant. People with uncontrolled infections or certain other health conditions are excluded.Inclusion Criteria
Patients meeting specific criteria for each of the 9 cohorts (A1, A2, B, C, C1, C2, D, E, F)
I am 18 years old or older.
I have brain or spinal cord disease that doesn’t cause symptoms.
+8 more
Exclusion Criteria
Use or intended use of any other investigational product, including herbal medications, through Study Treatment Termination
I currently have an active COVID-19 infection.
I have hepatitis or HIV but am not stable on medication, or I am stable with HIV and meet specific health criteria.
+12 more
Participant Groups
APL-101 Oral Capsules are being tested for their effectiveness as both a standalone treatment and an add-on therapy to EGFR inhibitors in patients with non-small cell lung cancer (NSCLC) and other solid tumors that show specific genetic alterations related to the MET gene.
9Treatment groups
Experimental Treatment
Group I: Primary CNS tumors with MET alterationsExperimental Treatment1 Intervention
Cohort E: APL-101 Oral Capsules
Group II: NSCLC MET amplification and EGFR wild-typeExperimental Treatment1 Intervention
Cohort C-1: APL-101 Oral Capsules
Group III: NSCLC Exon 14 Skip Treatment NaiveExperimental Treatment1 Intervention
Cohort A-1: APL-101 Oral Capsules
Group IV: NSCLC Exon 14 Skip Previously TreatedExperimental Treatment1 Intervention
Cohort A-2: APL-101 Oral Capsules
Group V: NSCLC Exon 14 MET Inhibitor ExperiencedExperimental Treatment1 Intervention
Cohort B: APL-101 Oral Capsules
Group VI: EGFR positive NSCLC MET amplification as an acquired resistanceExperimental Treatment1 Intervention
Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor
Group VII: Basket of tumor types wild-type MET with over-expression of HGF and METExperimental Treatment1 Intervention
Cohort F: APL-101 Oral Capsules
Group VIII: Basket of tumor types MET amplification except for primary CNS tumorsExperimental Treatment1 Intervention
Cohort C: APL-101 Oral Capsules
Group IX: Basket of solid tumor with MET gene fusions except for primary CNS tumorsExperimental Treatment1 Intervention
Cohort D: APL-101 Oral Capsules
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Christiana HospitalNewark, DE
Lady Davis Institute for Medical Research Jewish General HospitalMontreal, Canada
St. Francis Cancer CenterGreenville, SC
Miami Cancer InstituteMiami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Apollomics Inc.Lead Sponsor
References
Observation on the Clinical Effect of Apatinib Combined with Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer. [2022]To evaluate the clinical effect of apatinib combined with chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC).
A Phase II Clinical Trial of Apatinib in Pretreated Advanced Non-squamous Non-small-cell Lung Cancer. [2019]Apatinib exhibits broad-spectrum antitumor activities by selectively inhibiting vascular endothelial growth factor receptor-2. This study evaluated the efficacy and safety of apatinib in patients with advanced non-squamous non-small-cell lung cancer who were heavily pretreated or not suitable to receive standard second-line chemotherapy.
[Efficacy and Survival Analysis of Apatinib in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer after Failure of First-line Treatment]. [2018]The efficacy of second or third-line chemotherapy in advanced non-small cell lung cancer (NSCLC) patients is low. The use of targeted drugs brings survival benefit for some patients. Apatinib, as a novel small molecule antiangiogenic drug, has demonstrated satisfactory anticancer activity across a broad range of malignancies. The aim of this study is to evaluate the efficacy and safety of apatinib in patients with advanced NSCLC after first-line treatment failure.
Apatinib monotherapy for advanced non-small cell lung cancer after the failure of chemotherapy or other targeted therapy. [2019]Apatinib, a small-molecule inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), has proven to be effective and safe for treating patients with advanced gastric cancer after second-line chemotherapy failure. As VEGFR-2 targeted therapy has made encouraging progress for the treatment of a broad range of malignancies, we explored the efficacy and safety of apatinib for the treatment of advanced non-small cell lung cancer after the failure of chemotherapy or other targeted therapy.
Short-term efficacy and safety of apatinib in advanced squamous cell carcinoma of the lung. [2022]To evaluate the short-term efficacy and safety of apatinib alone or combined with chemotherapy in the treatment of advanced squamous cell lung cancer.