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Small Molecule Inhibitor
APL-101 for Lung Cancer (SPARTA Trial)
Phase 2
Recruiting
Led By Mark Awad, M.D.
Research Sponsored by Apollomics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0-1. For subjects with primary CNS tumors, KPS score ≥70
Women of child-bearing potential must have a negative serum or Beta-hCG at screening or evidence of surgical sterility or evidence of post-menopausal status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights
SPARTA Trial Summary
This trial is testing a new drug to see if it is safe and effective for people with different types of cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the trial information does not specify side effects, similar medications often cause digestive issues, fatigue, liver problems, skin reactions, and potential heart complications. Individual experiences may vary.
SPARTA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself and perform daily activities, or if I have a brain tumor, my health status allows me to live a normal life.
Select...
I am not pregnant, surgically sterile, or post-menopausal.
SPARTA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)
Secondary outcome measures
Antitumor activity by clinical benefit rate (CR + PR + SD ≥ 4 cycles) based on RECIST v1.1, RANO criteria for CNS tumors, or other relevant criteria per tumor type Median time to progression (TTP).
Median DOR per investigator assessment.
Median duration of response (DOR) per IRC.
+3 moreSPARTA Trial Design
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 Location
Who is running the clinical trial?
Apollomics Inc.Lead Sponsor
5 Previous Clinical Trials
252 Total Patients Enrolled
Marietta FrancoStudy DirectorApollomics Inc.
2 Previous Clinical Trials
191 Total Patients Enrolled
Mark Awad, M.D.Principal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have brain or spinal cord disease that doesn’t cause symptoms.My organs are functioning well.I currently have an active COVID-19 infection.You are expected to live for at least 3 months from the start of the study.I have hepatitis or HIV but am not stable on medication, or I am stable with HIV and meet specific health criteria.I cannot swallow pills whole.I had cancer before, but it was a type unlikely to come back within 3 years.My cancer has a specific change in genes like EGFR, ALK, etc., except if I'm in Cohort C or C-2 for NSCLC.I can provide a biopsy sample for the study, or I already have approved test results.I do not have any severe illnesses or conditions that could affect my safety or the study results.I have stable brain metastases and haven't increased my steroid dose in the last 2 weeks.My heart is functioning well.I am not pregnant, surgically sterile, or post-menopausal.I haven't had a recent heart attack or unstable heart issues, and I'm not on medication that affects my heart rhythm.I have a digestive condition that affects how medicines work in my body.I can stop taking certain medications that may interfere with the study drug.I can care for myself and perform daily activities, or if I have a brain tumor, my health status allows me to live a normal life.I do not have any major surgeries planned within the next 4 weeks.You are allergic to APL-101 or any other ingredients in the study treatment.I do not have any active, uncontrolled infections or other serious health conditions.I have at least one tumor that can be measured on a scan taken within the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Primary CNS tumors with MET alterations
- Group 2: Basket of solid tumor with MET gene fusions except for primary CNS tumors
- Group 3: NSCLC Exon 14 Skip Treatment Naive
- Group 4: NSCLC Exon 14 Skip Previously Treated
- Group 5: NSCLC Exon 14 MET Inhibitor Experienced
- Group 6: Basket of tumor types MET amplification except for primary CNS tumors
- Group 7: Basket of tumor types wild-type MET with over-expression of HGF and MET
- Group 8: NSCLC MET amplification and EGFR wild-type
- Group 9: EGFR positive NSCLC MET amplification as an acquired resistance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still able to add patients' names to the study?
"Yes, this study is still looking for participants and has not yet reached its target sample size. The trial was initially posted on September 27th, 2017 with the most recent update occurring on July 26th, 2022."
Answered by AI
Are many hospitals conducting this research within the US?
"To make participation more convenient for enrollees, this trial is being conducted at 42 sites. Some of these locations are in New Orleans, Kettering and Tacoma with the remaining 38 located elsewhere."
Answered by AI
How many people are enrolled in this trial?
"The sponsor, Apollomics Inc., needs to recruit 344 patients that fit the bill in order to commence this study. Multiple sites will be used including Ochsner Clinic Foundation and Kettering Health Network."
Answered by AI
What are we hoping to learn from this clinical trial?
"The main goal of this clinical trial is to assess the maximum tolerated dose (MTD) and incidence of DLTs over a period of 28 days. Secondary objectives include evaluating antitumor activity, median time to progression, and median duration of response."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Kaiser Permanente - CA
Kaiser Permanente - Vallejo
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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