Advanced Solid Tumors
Conditions
Brief summary
This is the first in human study of QLP2117. To evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in patients with advanced solid tumors.
Interventions
DRUGQLP2117
Specified dose on specified days
Sponsors
Qilu Pharmaceutical 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
1. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. 2. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion) 3. Eastern Cooperative Oncology Group Performance Status of 0 or 1 4. Agree to provide archived tumor tissue samples of primary or metastatic lesions. 5. Have adequate organ function as described in the protocol.
Exclusion criteria
1. Women who are pregnant or breastfeeding 2. HBsAg/HBcAb positive and HBV-DNA\>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication 3. Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment 4. Has an active autoimmune disease that has required systemic treatment in past 2 years. 5. Has an active infection requiring systemic therapy 6. Has received a live vaccine wihtin 30 days of planned start of study treatment 7. Has know history of, or any evidence of interstitial lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity(DLT) | 21days |
| Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | up to 96 weeks |
| Objective Response Rate for phase 1b | up to 96 weeks |
Countries
China
Contacts
Primary ContactZhang Meijiang, PhD
Outcome results
None listed