Advanced Solid Tumor Clinical Trial
— SHIELD-1Official title:
A Phase 1/2 of Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of TPX-0022 in Adult Subjects With Locally Advanced or Metastatic NSCLC, Gastric Cancer, or Solid Tumors Harboring Genetic Alterations in MET
Verified date | November 2023 |
Source | Turning Point Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A phase 1/2, first-in-human, open-label study of the safety, tolerability, PK, and efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced or metastatic NSCLC, Gastric Cancer, or solid tumors harboring genetic alterations in MET. (SHIELD-I)
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | March 2, 2025 |
Est. primary completion date | March 2, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 (or age = 20 as required by local regulation). 2. Histological or cytological confirmation of advanced/metastatic MET exon 14 skipping mutation (MET?ex14) NSCLC, MET amplified NSCLC, or MET amplified gastric cancers as determined by FISH, qPCR or NGS by local liquid biopsy or tissue, solid tumors with MET fusions or oncogenic MET mutations or MET amplified other than GI/NSCLC. 3. ECOG performance status = 1. 4. Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria). 5. Subjects with asymptomatic primary CNS tumors or brain metastases are eligible for the study if they meet protocol specified criteria. 6. Adequate organ function. 7. Life expectancy = 12 weeks. Exclusion Criteria: 1. Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy. 2. Presence or history of any other primary malignancy within the past 3 years other than a history of adequately treated basal or squamous cell carcinoma of the skin, or any adequately treated in situ carcinoma. 3. Major surgery within four weeks of the start of therapy. 4. Additional exclusion criteria for subjects with NSCLC with MET alterations: known oncogene mutations (eg, ALK, ROS1, KRAS, EGFR, etc.) for which there are approved therapies. 5. Additional exclusion criteria for subjects with HCC with MET alterations: liver dysfunction greater than Child-Pugh Class A. 6. Clinically significant cardiovascular disease (either active or within six months before enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class = II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of CTCAE version 5.0 grade = 2. 7. Any of the following cardiac criteria: - Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) > 470 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value - Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec) - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval 8. Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity). 9. Peripheral neuropathy = Grade 2. |
Country | Name | City | State |
---|---|---|---|
France | Local Institution - 4202 | La Tronche | Rhone-Alpes |
France | Local Institution - 4201 | Lyon | Rhone-Alpes |
France | Local Institution - 4203 | Saint-Mandé | Val-de-Marne |
France | Local Institution - 4204 | Villejuif | Val-de-Marne |
Korea, Democratic People's Republic of | Local Institution - 6304 | Seoul | |
Korea, Republic of | Local Institution - 6301 | Seoul | Seoul-teukbyeolsi [Seoul] |
Korea, Republic of | Local Institution - 6302 | Seoul | |
Korea, Republic of | Local Institution - 6303 | Seoul | |
Spain | Local Institution - 4101 | Madrid | |
Spain | Local Institution - 4103 | Madrid | |
Spain | Local Institution - 4104 | Madrid | |
Spain | Local Institution - 4102 | Pamplona | |
United States | Local Institution - 2106 | Ann Arbor | Michigan |
United States | Local Institution - 2107 | Boston | Massachusetts |
United States | Local Institution - 2109 | Boston | Massachusetts |
United States | Local Institution - 2111 | Chicago | Illinois |
United States | Local Institution - 2105 | Denver | Colorado |
United States | Local Institution - 2113 | Detroit | Michigan |
United States | Local Institution - 2112 | Fairfax | Virginia |
United States | Local Institution - 2101 | Houston | Texas |
United States | Local Institution - 2102 | La Jolla | California |
United States | Local Institution - 2108 | Orange | California |
United States | Local Institution - 2103 | Saint Louis | Missouri |
United States | Local Institution - 2104 | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
Turning Point Therapeutics, Inc. |
United States, France, Korea, Democratic People's Republic of, Korea, Republic of, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of first cycle dose-limiting toxicities (DLTs) of elzovantinib | Evaluate the safety and tolerability of elzovantinib | Within 28 days of the first elzovantinib dose for each patient | |
Primary | Define the Recommended Phase 2 Dose | Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of elzovantinib | Approximately 48 months | |
Secondary | Adverse events (AEs) | Evaluate the overall safety profile of elzovantinib | Approximately 48 months | |
Secondary | Cmax (maximum plasma concentration) of elzovantinib | Evaluate the maximum plasma concentration of elzovantinib | Up to 72 hours post-dose | |
Secondary | AUC (area under plasma concentration time curve) of elzovantinib | Evaluate the AUC of elzovantinib | Up to 72 hours post-dose | |
Secondary | Cmax (maximum plasma concentration) of TPX-0022 under different food intake conditions | Determine the effect of food (specifically, a high-fat, high-calorie meal) on the single-dose PK (Cmax) of elzovantinib at the RP2D | Up to 72 hours post-dose | |
Secondary | AUC (area under plasma concentration time curve) of elzovantinib under different food intake conditions | Determine the effect of food (specifically, a high-fat, high-calorie meal) on the single-dose PK (AUC) of elzovantinib at the RP2D | Up to 72 hours post-dose | |
Secondary | Preliminary Objective Response Rate (ORR) | Determine the preliminary objective response rate (ORR) by Blinded Independent Central Review (BICR) of elzovantinib | Approximately 48 months | |
Secondary | Clinical benefit rate (CBR) | Determine the CBR of elzovantinib | Approximately 48 months | |
Secondary | Time to response (TTR) | Determine the TTR of elzovantinib | Approximately 48 months | |
Secondary | Duration of Response (DOR) | Determine the DOR of elzovantinib | Approximately 48 months | |
Secondary | Progression free survival (PFS) | Determine the PFS of elzovantinib | Approximately 48 months | |
Secondary | Intracranial tumor response | Determine the intracranial tumor response in subjects with measurable brain metastases, as determined by BICR | Approximately 48 months | |
Secondary | Overall survival (OS) | Determine efficacy and safety of elzovantinib | Approximately 48 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT05508100 -
Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT05515185 -
B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors
|
Early Phase 1 | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT02836600 -
A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04890613 -
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
|
Phase 1 | |
Recruiting |
NCT04390737 -
Evaluate the Safety and Clinical Activity of HH2853
|
Phase 1/Phase 2 | |
Recruiting |
NCT05981703 -
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06007482 -
A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT04108676 -
Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects
|
Phase 1 | |
Recruiting |
NCT05798611 -
Study of ART0380 in Patients With Biologically Selected Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05076396 -
PM14 Administered Intravenously to Patients With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06008366 -
A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06054932 -
Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04825392 -
A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT06365918 -
Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis
|
Phase 1 | |
Recruiting |
NCT05443126 -
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05569057 -
A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma
|
Phase 1 | |
Recruiting |
NCT05461287 -
Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors
|
Phase 1 |