Advanced Solid Tumor, Esophageal Squamous Cell Carcinoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Conditions
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.
Interventions
DRUGJAB-3068
JAB-3068 administrated orally as a tablet.
DRUGPD1 inhibitor
JS001 administrated as an intravenous(IV) infusion.
Sponsors
AbbVie
Jacobio Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dose limiting toxicities | 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) | 24 months | ORR is defined as the proportion of participants with complete response or partial response (CR+PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | 24 months | Area under the plasma concentration time curve of JAB-3068 and JS001 |
| Duration of response ( DCR ) | 24 months | DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). |
| Progression-free survival (PFS) | 24 months | 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. |
| Plasma concentration (Cmax) | 24 months | Highest observed plasma concentration of JAB-3068 and JS001 |
| Overall survival (OS) | 24 months | 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. |
| Number of Participants with Treatment-related Adverse Events(TRAE) | 24 months | TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug. |
| Duration of response ( DOR ) | 24 months | 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. |
| Time to achieve Cmax (Tmax) | 24 months | Time of highest observed plasma concentration of JAB-3068 and JS001 |
Countries
China
Outcome results
None listed