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. ^{1 2 3 4 5}

Research Team

Peony Yu

Principal Investigator

Apollomics Inc.

Eligibility 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.

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive APL-101 as monotherapy or in combination with EGFR inhibitors, depending on cohort assignment

Approximately 2 years

1 cycle = 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 years

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Approximately 3 years

Treatment Details

Interventions

• APL-101 (Small Molecule Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Primary CNS tumors with MET alterations Experimental Treatment 1 Intervention

Cohort E: APL-101 Oral Capsules

Group II: NSCLC MET amplification and EGFR wild-type Experimental Treatment 1 Intervention

Cohort C-1: APL-101 Oral Capsules

Group III: NSCLC Exon 14 Skip Treatment Naive Experimental Treatment 1 Intervention

Cohort A-1: APL-101 Oral Capsules

Group IV: NSCLC Exon 14 Skip Previously Treated Experimental Treatment 1 Intervention

Cohort A-2: APL-101 Oral Capsules

Group V: NSCLC Exon 14 MET Inhibitor Experienced Experimental Treatment 1 Intervention

Cohort B: APL-101 Oral Capsules

Group VI: EGFR positive NSCLC MET amplification as an acquired resistance Experimental Treatment 1 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 MET Experimental Treatment 1 Intervention

Cohort F: APL-101 Oral Capsules

Group VIII: Basket of tumor types MET amplification except for primary CNS tumors Experimental Treatment 1 Intervention

Cohort C: APL-101 Oral Capsules

Group IX: Basket of solid tumor with MET gene fusions except for primary CNS tumors Experimental Treatment 1 Intervention

Cohort D: APL-101 Oral Capsules

Who Is Running the Clinical Trial?

Apollomics Inc.

Lead Sponsor

Trials

6

Recruited

750+

Findings from Research

In a study of 80 patients with advanced non-small cell lung cancer, the combination of apatinib and chemotherapy resulted in a total effective rate of 67.5%, significantly higher than the 45% effectiveness of chemotherapy alone.

Patients receiving apatinib also experienced a greater improvement in quality of life scores and lower levels of tumor markers (CEA and CA153) after treatment, with no significant increase in adverse reactions compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observation on the Clinical Effect of Apatinib Combined with Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer. Cui, YJ., Liu, J., Liu, MM., et al.[2022]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Observation on the Clinical Effect of Apatinib Combined with Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Phase II Clinical Trial of Apatinib in Pretreated Advanced Non-squamous Non-small-cell Lung Cancer. [2019]

3. China pubmed.ncbi.nlm.nih.gov

[Efficacy and Survival Analysis of Apatinib in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer after Failure of First-line Treatment]. [2018]

4. Singapore pubmed.ncbi.nlm.nih.gov

Apatinib monotherapy for advanced non-small cell lung cancer after the failure of chemotherapy or other targeted therapy. [2019]

5. India pubmed.ncbi.nlm.nih.gov

Short-term efficacy and safety of apatinib in advanced squamous cell carcinoma of the lung. [2022]