JAB-3312 Activity in Adult Patients With Advanced Solid Tumors

  • Interventional
  • Recruiting
  • NCT04720976
Eligibility Details Visit Clinicaltrials.gov

A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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
  • Solid Tumors

At a Glance

National Government IDNCT04720976

IRB#IRB21-0534

Lead SponsorJacobio Pharmaceuticals Co., Ltd.

Lead PhysicianArdaman Shergill

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting