A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: QLP2117

Study type: Interventional

Funder types: Industry

Identifiers

NCT05830045

QLP2117-101

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Ia： QLP2117 Dose escalation and PK expansion

Experimental group

Treatment:

Drug: QLP2117

Ib：QLP2117 Dose expansion

Experimental group

Treatment:

Drug: QLP2117