JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

Jacobio Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Solid Tumor; Esophageal Squamous Cell Carcinoma; Non Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma

Treatments: Drug: JAB-3068; Drug: PD1 inhibitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04721223

JAB-3068-03

Details and patient eligibility

About

To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

JAB-3068+PD1 inhibitor Part1

Experimental group

Description:

JAB-3068+JS001 dose escalation

Treatment:

Drug: PD1 inhibitor

Drug: JAB-3068

JAB-3068+PD1 inhibitor Part2

Experimental group

Description:

JAB-3068+JS001 dose expansion

Treatment:

Drug: PD1 inhibitor

Drug: JAB-3068