JAB-3312 Activity in Adult Patients With Advanced Solid Tumors
- Interventional
- Recruiting
- NCT04720976
Contact Information
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
- 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