Solid Tumors Clinical Trial
Official title:
A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
| Status | Recruiting |
| Enrollment | 102 |
| Est. completion date | August 2026 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Must be able to provide an archived tumor sample - Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor - Dose Expansion phase cohorts must meet specific expression or gene mutation where indicated - Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition - Must have at least 1 measurable lesion per RECIST v1.1 - Must have adequate organ functions - Must be able to swallow and retain orally administered medication Exclusion Criteria: - Has central nervous system (CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days - Active infection requiring systemic treatment within 7 days - Active hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV - Any severe and/or uncontrolled medical conditions - left ventricular ejection fraction (LVEF) =50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA) - QT interval using Fridericia's formula (QTcF) interval >470 msec - Experiencing unresolved CTCAE 5.0 Grade >1 toxicities - Clinically significant eye disorders |
| Country | Name | City | State |
|---|---|---|---|
| China | Research site02 | Beijing | Beijing |
| China | Research site01 | Changchun | Jilin |
| China | Research site03 | Jinan | Shandong |
| United States | Mary Crowley Cancer Research | Dallas | Texas |
| United States | University of Utah Huntsman Cancer Institute | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Jacobio Pharmaceuticals Co., Ltd. |
United States, China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) | A DLT is defined as an adverse event (AE) regardless of attribution unless clearly related to underlying disease or extraneous cause during the first 21 days of Cycle 1 (DLT observation period). | First 21 days of Cycle 1 | |
| Primary | Dose Escalation phase: Number of participants with adverse events (AEs) | Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0 | Up to 3 years | |
| Primary | Dose Expansion phase: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1 | Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD) | |
| Primary | Dose Expansion phase: Duration of Response (DOR) | DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first. | Up to 3 years | |
| Secondary | Dose Escalation phase: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with PR or CR based on RECIST v1.1 | Up to 3 years from baseline to RECIST confirmed Progressive Disease (PD) | |
| Secondary | Dose Escalation and Dose Expansion phase: Time to response (TTR) | TTR is defined as the interval of time between the date of first treatment to the first documented response (CR or PR) as determined by investigator assessment per RECIST v1.1 | Up to 3 years | |
| Secondary | Dose Escalation phase: Duration of Response (DOR) | DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first | Up to 3 years | |
| Secondary | Dose Escalation and Dose Expansion phase: peak plasma concentration (Cmax) | Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples, including peak plasma concentration (Cmax) | Up to 3 years | |
| Secondary | Dose Escalation and Dose Expansion phase: time to peak plasma concentration(Tmax) | Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including time to peak plasma concentration (tmax) | Up to 3 years | |
| Secondary | Dose Escalation and Dose Expansion phase: Ctrough | Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including pre-dose through concentration (Ctrough) | Up to 3 years | |
| Secondary | Dose Escalation and Dose Expansion phase: Area under the curve (AUC) | Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including area under the plasma concentration versus time curve (AUC) | Up to 3 years | |
| Secondary | Dose Escalation and Dose Expansion phase: half-life (t½) | Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including half-life (t½) | Up to 3 years | |
| Secondary | Dose Escalation and Dose Expansion phase: total body clearance | Pharmacokinetic (PK) parameters of JAB-2485 monotherapy and the food effect assessment by using plasma or urine PK samples. Including total body clearance | Up to 3 years | |
| Secondary | Dose Expansion phase: Progression Free Survival (PFS) | PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST v1.1 or death which occurs first. | Up to 3 years | |
| Secondary | Dose Expansion Phase 2a: Overall Survival (OS) | OS is defined as the length of time between the date of first treatment to the date of death | Up to 3 years | |
| Secondary | Dose Expansion phase: Disease Control Rate (DCR) | DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 | Up to 3 years | |
| Secondary | Dose Expansion phase: Number of participants with adverse events (AEs) | Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE v5.0 | Up to 3 years |
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