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APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

ConditionsSolid TumorsAdvanced CancerRenal CancerGastric CancerGastroesophageal Junction AdenocarcinomaNSCLCLung CancerBrain TumorGlioblastoma MultiformeEGFR Gene MutationMET AmplificationHGFThyroid CancerPancreatic CancerColon CancerMET AlterationMET FusionExon 14 Skipping
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorApollomics Inc.

About this trial

To assess:

* efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET * efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women 18 years of age or older.

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 (Stage 3b/4); treatment-naive subjects in first line; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations

Cohort A2 / Exon 14 NSCLC - MET inhibitor naïve: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease (Stage 3b/4); pretreated subjects refractory to or intolerant of standard therapies with no more than three lines of prior therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations

Cohort B / Exon 14 NSCLC MET inhibitor experienced: ENROLLMENT COMPLETED

Disqualifiers

Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.

Known actionable mutation/gene rearrangement of EGFR (except for NSCLC subjects in Cohort C and C-2), ALK, ROS1, RET, NTRK, KRAS, and BRAF.

Use or intended use of any other investigational product, including herbal medications, through Study Treatment Termination.

Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process, which in the opinion of the investigator makes the risk: benefit unfavorable for the participation of the trial.

Trial design

Design model

Single group

Treatments tested in this trial

  • APL-101 Oral Capsules

    Drug

    Subjects will receive APL-101 capsules BID for oral administration.

Treatment groups

497 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: NSCLC Exon 14 Skip Treatment NaiveExperimental treatment 1 intervention
Group B: NSCLC Exon 14 Skip Previously TreatedExperimental treatment 1 intervention
Group C: NSCLC Exon 14 MET Inhibitor ExperiencedExperimental treatment 1 intervention
Group D: Basket of tumor types MET amplification except for primary CNS tumorsExperimental treatment 1 intervention
Group E: NSCLC MET amplification and EGFR wild-typeExperimental treatment 1 intervention
Group F: EGFR positive NSCLC MET amplification as an acquired resistanceExperimental treatment 1 intervention
Group G: Basket of solid tumor with MET gene fusions except for primary CNS tumorsExperimental treatment 1 intervention
Group H: Primary CNS tumors with MET alterationsExperimental treatment 1 intervention
Group I: Basket of tumor types wild-type MET with over-expression of HGF and METExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)

Anti-tumor activity per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.

Time frame
From time of informed consent signature through completion of treatment (1 cycle = 28 days) or progression

Secondary outcomes

1

Median duration of response (DOR) per IRC.

DOR per RECIST v1.1 criteria, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.

Time frame
Approximately 2 years
2

ORR per investigator assessment based on RECIST v1.1.

ORR per RECIST v1.1 or relevant evaluation criteria per tumor type.

Time frame
Approximately 2 years
3

Median DOR per investigator assessment.

DOR per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.

Time frame
Approximately 2 years
4

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).

Benefit rate per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Apollomics Inc.

Lead sponsor

Source ClinicalTrials.gov
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