Clinical Trials /

JAB-3312 Activity in Adult Patients With Advanced Solid Tumors

NCT04720976

Description:

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04720976

Trial Eligibility

Document

Title

  • Brief Title: JAB-3312 Activity in Adult Patients With Advanced Solid Tumors
  • 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-3312 in Combination With Pembrolizumab or Binimetinib in Adult Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: JAB-3312-1003
  • NCT ID: NCT04720976

Conditions

  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
JAB-3312JAB-3312+ Binimetinib dose escalation
BinimetinibJAB-3312+ Binimetinib dose escalation
PembrolizumabJAB-3312+Pembrolizumab dose escalation

Purpose

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

Detailed Description

      To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of
      JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid
      tumors.

Trial Arms

NameTypeDescriptionInterventions
JAB-3312+Pembrolizumab dose escalationExperimentalDose escalation part 1
  • JAB-3312
  • Pembrolizumab
JAB-3312+ Binimetinib dose escalationExperimentalDose escalation part2
  • JAB-3312
  • Binimetinib
JAB-3312+Pembrolizumab dose expansionExperimentalDose expansion part1
  • JAB-3312
  • Pembrolizumab
JAB-3312+Binimetinib dose expansionExperimentalDose expansion part2
  • JAB-3312
  • Binimetinib

Eligibility Criteria

        Inclusion Criteria:

          -  Written informed consent, according to local guidelines, signed and dated by the
             participant prior to the performance of any study-specific procedures, sampling, or
             analyses.

          -  Participant must be ≥18 years of age at the time of signature of the informed consent
             form (ICF).

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

          -  Sufficient organ function

          -  Participants with a life expectancy ≥3 months

          -  Participants must have at least 1 measurable lesion as defined by Response Evaluation
             Criteria in Solid Tumors (RECIST) v1.1.

        Exclusion Criteria:

          -  History of cancer that is histologically distinct from the cancers under study

          -  Brain or spinal metastases

          -  History of severe autoimmune disease or autoimmune disorder that requires chronic
             systemic corticosteroid treatment.

          -  Has active hepatitis B, or hepatitis C infection
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with dose limiting toxicities
Time Frame:24 months
Safety Issue:
Description:Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:24 months
Safety Issue:
Description:ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)
Measure:Duration of response ( DOR )
Time Frame:24 months
Safety Issue:
Description:DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose escalation phase)
Measure:Duration of response ( DCR )
Time Frame:24 months
Safety Issue:
Description:DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)
Measure:Progression-free survival (PFS)
Time Frame:24 months
Safety Issue:
Description:PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose escalation phase)
Measure:Overall survival (OS)
Time Frame:24 months
Safety Issue:
Description:OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor(Dose escalation phase)
Measure:Plasma concentration (Cmax)
Time Frame:24 months
Safety Issue:
Description:Highest observed plasma concentration of JAB-3312(dose escalation phase)
Measure:Time to achieve Cmax (Tmax)
Time Frame:24 months
Safety Issue:
Description:Time of highest observed plasma concentration of JAB-3312(dose escalation phase)
Measure:Area under the plasma concentration-time curve (AUC)
Time Frame:24 months
Safety Issue:
Description:Area under the plasma concentration time curve of JAB-3312(dose escalation phase)

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jacobio Pharmaceuticals Co., Ltd.

Last Updated

May 25, 2021