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Also known as APL-101 Oral Capsules
APL-101 · 2 trials · 19 indications
Anti-tumor activity per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
-Toxicity is measured by CTCAE v 5.0
-Toxicity is measured by CTCAE v 5.0
* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up date. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
| Arm | Type | Description |
|---|---|---|
| NSCLC Exon 14 Skip Treatment Naive | EXPERIMENTAL | Cohort A-1: APL-101 Oral Capsules |
| NSCLC Exon 14 Skip Previously Treated | EXPERIMENTAL | Cohort A-2: APL-101 Oral Capsules |
| NSCLC Exon 14 MET Inhibitor Experienced | EXPERIMENTAL | Cohort B: APL-101 Oral Capsules |
| Basket of tumor types MET amplification except for primary CNS tumors | EXPERIMENTAL | Cohort C: APL-101 Oral Capsules |
| NSCLC MET amplification and EGFR wild-type | EXPERIMENTAL | Cohort C-1: APL-101 Oral Capsules |
| EGFR positive NSCLC MET amplification as an acquired resistance | EXPERIMENTAL | Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor |
| Basket of solid tumor with MET gene fusions except for primary CNS tumors | EXPERIMENTAL | Cohort D: APL-101 Oral Capsules |
| Primary CNS tumors with MET alterations | EXPERIMENTAL | Cohort E: APL-101 Oral Capsules |
| Basket of tumor types wild-type MET with over-expression of HGF and MET | EXPERIMENTAL | Cohort F: APL-101 Oral Capsules |
| Phase I Dose Level 1: APL-101 + Standard of Care Osimertinib | EXPERIMENTAL | * After 8-16 weeks of osimertinib, patients will be imaged as per standard of care. If imaging does not show disease progression, patients will continue on to study treatment with the combination of osimertinib and APL-101. * APL-101 is an oral drug which will be administered on an outpatient basis at the assigned dose twice daily on Days 1 through 28 of each 28-day cycle * Osimertinib is an oral drug which will be administered on an outpatient basis at a dose of 80 mg once daily on Days 1 through 28 of each 28-day cycle. |
| Phase I Dose Level 2: APL-101 + Standard of Care Osimertinib | EXPERIMENTAL | * After 8-16 weeks of osimertinib, patients will be imaged as per standard of care. If imaging does not show disease progression, patients will continue on to study treatment with the combination of osimertinib and APL-101. * APL-101 is an oral drug which will be administered on an outpatient basis at the assigned dose twice daily on Days 1 through 28 of each 28-day cycle * Osimertinib is an oral drug which will be administered on an outpatient basis at a dose of 80 mg once daily on Days 1 through 28 of each 28-day cycle. |
| Phase II: APL-101 + Standard of Care Osimertinib | EXPERIMENTAL | * After 8-16 weeks of osimertinib, patients will be imaged as per standard of care. If imaging does not show disease progression, patients will continue on to study treatment with the combination of osimertinib and APL-101. * APL-101 is an oral drug which will be administered on an outpatient basis at the assigned dose (this dose will be determined in Phase I of the study) twice daily on Days 1 through 28 of each 28-day cycle * Osimertinib is an oral drug which will be administered on an outpatient basis at a dose of 80 mg once daily on Days 1 through 28 of each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| APL-101 Oral Capsules | DRUG | Subjects will receive APL-101 capsules BID for oral administration. |
| APL-101 | DRUG | -Provided by Apollomics |
| Osimertinib | DRUG | -Given standard of care |
Major Inclusion Criteria: 1. Men and women 18 years of age or older. 2. 9 cohorts will be enrolled: * Cohort A1 / Exon 14 NSCLC MET inhibitor naive in first line: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
APL-101 is an investigational oral small molecule c-Met inhibitor being developed by Apollomics Inc. (ticker APLM). It is being studied in metastatic non-small cell lung cancer and advanced solid tumors, including tumors with c-Met exon 14 skipping mutations and other c-Met dysregulation. It is not yet approved and remains in clinical development.
APL-101 is being studied in metastatic non-small cell lung cancer, both as a single agent in patients whose tumors have c-Met exon 14 skipping mutations or c-Met dysregulation, and in combination with frontline osimertinib in patients with EGFR-mutated metastatic NSCLC. It is investigational and has not been approved for any indication.
APL-101 targets c-Met, a receptor tyrosine kinase also known as the hepatocyte growth factor receptor. By inhibiting c-Met, APL-101 is designed to interfere with signaling that drives tumor growth and survival in cancers with c-Met alterations such as exon 14 skipping mutations, amplification, or fusions.
APL-101 is being developed by Apollomics Inc., which trades under the ticker APLM. The company is running clinical studies of the drug in the United States and internationally, including sites across North America, Europe, Asia, and Australia.
APL-101 is in clinical development. One Phase 1 trial, NCT04743505, evaluates APL-101 combined with frontline osimertinib in EGFR-mutated metastatic NSCLC and is active but not recruiting. A Phase 2 trial, NCT03175224, is recruiting patients with c-Met exon 14 skipping mutations and c-Met dysregulated advanced solid tumors.
APL-101 is being studied in two registered trials. NCT04743505 is a Phase 1 study of APL-101 plus frontline osimertinib in EGFR-mutated metastatic NSCLC, with 27 patients enrolled in the United States. NCT03175224 is a recruiting Phase 2 study in c-Met exon 14 skipping NSCLC and c-Met dysregulated advanced solid tumors, with 497 patients across multiple countries.
Yes. APL-101 Oral Capsules is another name for APL-101, the investigational c-Met inhibitor developed by Apollomics Inc. (APLM). Both names refer to the same oral small molecule drug candidate being studied in metastatic non-small cell lung cancer and advanced solid tumors.