Clinical trial NCT04721223: JAB-3068 Activity in Adult Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Esophageal Squamous Cell Carcinoma
Non Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2021-01-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Number of participants with dose limiting toxicities
timeFrame: 24 months
measure: Objective response rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Plasma concentration (Cmax)
timeFrame: 24 months
measure: Time to achieve Cmax (Tmax)
timeFrame: 24 months
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 24 months
measure: Duration of response ( DCR )
timeFrame: 24 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Duration of response ( DOR )
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: Number of Participants with Treatment-related Adverse Events(TRAE)
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
References: