A Phase 1b/2a, Multi-Center, Open-Label，Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JAB-3068 in Combination With JS001 in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Enrollment
- 118
- Locations
- 3
- Primary Endpoint
- Number of participants with dose limiting toxicities
Overview
Brief Summary
To evaluate the safety and tolerability of JAB-3068 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-3068 in combination with PD1 inhibitor in patients with advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Exclusion Criteria
- •History (≤3 years) of cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer
- •Known serious allergy to experimental drugs
- •Brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage for ≤21 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥21 days before the start of treatment with the study drugs
Arms & Interventions
JAB-3068+PD1 inhibitor Part1
JAB-3068+JS001 dose escalation
Intervention: JAB-3068 (Drug)
JAB-3068+PD1 inhibitor Part1
JAB-3068+JS001 dose escalation
Intervention: PD1 inhibitor (Drug)
JAB-3068+PD1 inhibitor Part2
JAB-3068+JS001 dose expansion
Intervention: JAB-3068 (Drug)
JAB-3068+PD1 inhibitor Part2
JAB-3068+JS001 dose expansion
Intervention: PD1 inhibitor (Drug)
Outcomes
Primary Outcomes
Number of participants with dose limiting toxicities
Time Frame: 24 months
Incidence of dose limiting toxicities (DLTs) . 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 with JAB-3068 and JS001.
Objective response rate (ORR)
Time Frame: 24 months
ORR is defined as the proportion of participants with complete response or partial response (CR+PR).
Secondary Outcomes
- Number of Participants with Treatment-related Adverse Events(TRAE)(24 months)
- Duration of response ( DOR )(24 months)
- Overall survival (OS)(24 months)
- Time to achieve Cmax (Tmax)(24 months)
- Duration of response ( DCR )(24 months)
- Plasma concentration (Cmax)(24 months)
- Area under the plasma concentration-time curve (AUC)(24 months)
- Progression-free survival (PFS)(24 months)