| Primary | Dose Escalation (Phase 1): Safety Analysis - Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | | Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630. | Posted | | Count of Participants | | Participants | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles). | | OG004 | Dose Escalation (12 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (12 mg) once daily in a continuous regimen (28-day cycles). | | OG005 | Dose Escalation (18 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (18 mg) once daily in a continuous regimen (28-day cycles). | | OG006 | Dose Escalation (27 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (27 mg) once daily in a continuous regimen (28-day cycles). |
| | | Title | Denominators | Categories |
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| Primary | Dose Escalation (Phase 1): Safety Analysis - Number of Participants With Dose-limiting Toxicities (DLTs) Following Oral Administration of THE-630 | | DLT-Evaluable Analysis Set (Phase 1 only), which includes patients enrolled in the Dose Escalation (Phase 1) portion who completed at least 75% of the planned total dose during Cycle 1 (DLT evaluation period, i.e. 21 of 28 days) and patients who experienced a protocol-defined DLT, regardless of dosing adherence in Cycle 1. | Posted | | Count of Participants | | Participants | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 |
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| Primary | Dose Escalation (Phase 1): Safety Analysis - Maximum Tolerated Dose (MTD) of Orally Administered THE-630 | The MTD is defined as the highest dose at which ≤1 of 6 DLT-assessment eligible patients experience a DLT within the first 28 days of treatment (end of Cycle 1). | DLT-Evaluable Analysis Set (Phase 1 only), which includes patients enrolled in the Dose Escalation (Phase 1) portion who completed at least 75% of the planned total dose during Cycle 1 (DLT evaluation period, i.e. 21 of 28 days) and patients who experienced a protocol-defined DLT, regardless of dosing adherence in Cycle 1. | Posted | | Number | | mg | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg to 27 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg, 4 mg, 6 mg, 9 mg, 12 mg, 18 mg, or 27 mg) once daily in a continuous regimen (28-day cycles). |
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| Primary | Dose Escalation (Phase 1): Recommended Phase 2 Dose (RP2D) of Orally Administered THE-630 | The RP2D was expected to be equal to the MTD or less than the MTD, if aspects of tolerability or efficacy not encompassed by the MTD determination suggested utilizing a lower dose. | DLT-Evaluable Analysis Set (Phase 1 only), which includes patients enrolled in the Dose Escalation (Phase 1) portion who completed at least 75% of the planned total dose during Cycle 1 (DLT evaluation period, i.e. 21 of 28 days) and patients who experienced a protocol-defined DLT, regardless of dosing adherence in Cycle 1. | Posted | | Number | | mg | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg to 27 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg, 4 mg, 6 mg, 9 mg, 12 mg, 18 mg, or 27 mg) once daily in a continuous regimen (28-day cycles). |
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| Primary | Expansion (Phase 2): Efficacy Assessment - For Each Expansion Phase Cohort (Cohorts 1, 2, and 3), Confirmed Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | | The Sponsor terminated the study due to early dose-limiting toxicities and not initiate Expansion Cohort 1, Expansion Cohort 2 or Expansion Cohort 3 (Phase 2). | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
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| Secondary | Dose Escalation (Phase 1): Plasma Pharmacokinetic (PK) Parameters of THE-630 and Its Active Metabolite - Cmax (Maximum Observed Concentration) | Cmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses | The scope of planned analyses and data reporting was reduced (per statistical analysis plan [SAP] v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). |
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| Secondary | Dose Escalation (Phase 1): Plasma PK Parameters of THE-630 and Its Active Metabolite - Tmax (Time of First Occurrence of Cmax) | Tmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses | The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). |
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| Secondary | Dose Escalation (Phase 1): Plasma PK Parameters of THE-630 and Its Active Metabolite - AUC 0-24 (Area Under the Concentration-time Curve From Time Zero to 24 Hours) | AUC 0-24 of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses | The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). |
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| Secondary | Dose Escalation (Phase 1): Plasma PK Parameters of THE-630 and Its Active Metabolite - AUC 0-t (Area Under the Concentration-time Curve From Time Zero to Time t) | AUC 0-t of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses | The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Confirmed ORR, According to Modified RECIST 1.1 | | Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles). |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Best Overall Response, According to Modified RECIST 1.1 | | Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630. | Posted | | Count of Participants | | Participants | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles). |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Best Target Lesion Response, According to Modified RECIST 1.1 | | The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Time to Response, According to Modified RECIST 1.1 | | The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Duration of Response (DOR), According to Modified RECIST 1.1 | | The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Disease Control Rate (DCR), According to Modified RECIST 1.1 | | Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles). |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Clinical Benefit Rate (CBR) at 16 Weeks, According to Modified RECIST 1.1 | | Full Analysis Set, which includes all patients who were enrolled and received at least 1 dose of THE-630. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (9 mg) once daily in a continuous regimen (28-day cycles). |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Progression Free Survival (PFS), According to Modified RECIST 1.1 | | The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | |
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| Secondary | Dose Escalation (Phase 1): Efficacy Assessment - Overall Survival (OS) | | The scope of planned analyses and data reporting was reduced (per SAP v3.0), given the Sponsor's decision to terminate the study early due to dose-limiting toxicities and to discontinue the THE-630 development program. As a result, data for this outcome measure are not available. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Dose Escalation (3 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (3 mg) once daily in a continuous regimen (28-day cycles). | | OG001 | Dose Escalation (4 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (4 mg) once daily in a continuous regimen (28-day cycles). | | OG002 | Dose Escalation (6 mg Once Daily) | Patients with unresectable or metastatic GIST who received orally administered THE-630 (6 mg) once daily in a continuous regimen (28-day cycles). | | OG003 | Dose Escalation (9 mg Once Daily) | |
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| Secondary | Expansion (Phase 2): Efficacy Assessment - Best Overall Response, According to Modified RECIST 1.1 | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
|
| Secondary | Expansion (Phase 2): Efficacy Assessment - Best Target Lesion Response, According to Modified RECIST 1.1 | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
|
| Secondary | Expansion (Phase 2): Efficacy Assessment - Time to Response, According to Modified RECIST 1.1 | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
|
| Secondary | Expansion (Phase 2): Efficacy Assessment - DOR, According to Modified RECIST 1.1 | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
|
| Secondary | Expansion (Phase 2): Efficacy Assessment - DCR, According to Modified RECIST 1.1 | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
|
| Secondary | Expansion (Phase 2): Efficacy Assessment - CBR at 16 Weeks, According to Modified RECIST 1.1 | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
|
| Secondary | Expansion (Phase 2): Efficacy Assessment - PFS, According to Modified RECIST 1.1 | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
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| Secondary | Expansion (Phase 2): Efficacy Assessment - OS | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
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| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
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| Secondary | Expansion (Phase 2): Safety Analysis - Number of Participants With Treatment-emergent Adverse Events as Assessed by NCI CTCAE v5.0 | | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Up to 24 months after first dose | | | | ID | Title | Description |
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| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib (including in the adjuvant setting) and who have not received additional systemic therapy for advanced GIST, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. |
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| Secondary | Expansion (Phase 2): Plasma PK Parameters of THE-630 and Its Active Metabolite - Cmax (Maximum Observed Concentration) | Cmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days) | | | | ID | Title | Description |
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| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | |
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| Secondary | Expansion (Phase 2): Plasma PK Parameters of THE-630 and Its Active Metabolite - Tmax (Time of First Occurrence of Cmax) | Tmax of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days) | | | | ID | Title | Description |
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| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | |
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| Secondary | Expansion (Phase 2): Plasma PK Parameters of THE-630 and Its Active Metabolite - AUC 0-24 (Area Under the Concentration-time Curve From Time Zero to 24 Hours) | AUC 0-24 of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | |
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| Secondary | Expansion (Phase 2): Plasma PK Parameters of THE-630 and Its Active Metabolite - AUC 0-t (Area Under the Concentration-time Curve From Time Zero to Time t) | AUC 0-t of THE-630 and its active metabolite after single oral dose and at steady state after multiple oral doses | No patients were enrolled in the Expansion cohorts, as the study was terminated by the Sponsor due to dose-limiting toxicities prior to initiation of the Expansion phase (Phase 2) of the study. | Posted | | | | | | Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is 28 days) | | | | ID | Title | Description |
|---|
| OG000 | Expansion Cohort 1 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib, regorafenib and ripretinib who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG001 | Expansion Cohort 2 | Patients with unresectable or metastatic GIST who have progressed on or are intolerant to imatinib, sunitinib and 0-1 additional lines of therapy in the advanced/metastatic setting, who will receive orally administered THE-630 (once daily in a continuous regimen) at the recommended Phase 2 dose based on the dose escalation phase. | | OG002 | Expansion Cohort 3 | |
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