Metastatic Solid Tumors
Conditions
Brief summary
The goal of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS5308 monotherapy in participants with Advanced Solid Tumors. This study is divided into two phases: Phase Ia is the dose escalation phase, where dose escalation of QLS5308 conducted and RP2D is explored; In the Phase Ib tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLS5308 with advanced solid tumors.
Interventions
DRUGQLS5308 IV infusion
Participants will receive escalating doses of QLS5308 (0.8, 1.6, 3.2, 4.0, 4.8, 5.6, 6.4 mg/kg) intravenously on Day 1 of each 21-day cycle.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1. * Has adequate organ function. * The expected survival period is ≥3 months. * Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy. * According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion.
Exclusion criteria
* Prior treatment with LIV1-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs. * There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product. * Active, uncontrolled bacterial, fungal or viral infections. * Participants with moderate to large amounts of uncontrolled pleural, pericardial, or peritoneal effusions before the first dose (those who remain stable for at least 2 weeks after drainage may be enrolled). * Subjects with a history of a second malignant tumor other than the target indication within 3 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.). * Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade 2. * Active autoimmune disease that requires systemic treatment or has the potential to recur.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLS5308 in patients with advanced solid tumors. | up to 12 months | — |
| Number of participants who experience one or more adverse events(AEs). | up to 48 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | up to 36 months | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigator. |
| DOR | up to 48 months | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator. |
| PFS | up to 48 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version1.1 (RECIST 1.1). PD is defined as ≥20%increase in the sum of diameters of target lesions. In addition to the relative increase of20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearanceof one or more new lesions is alsoconsidered PD. PFS as assessed by investigator. |
| OS | up to 60 months | OS is defined as the time from randomization to death due to any cause. |
Contacts
CONTACTShusen Wang, Doctor
Outcome results
None listed