Sarcomas, Solid Tumors
Conditions
Keywords
Sarcoma, Solid Tumors, Phase1, Antibody-Drug Conjugate (ADC), Leucine-Rich Repeat-Containing protein 15 (LRRC15)
Brief summary
The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.
Detailed description
An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants with Sarcoma and Selected Solid Tumors
Interventions
DRUGZL-6201
ZL-6201 as a single-agent
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Zai Lab (US) LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men and women ≥18 years of age at the time of signing the ICF with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy \> 3 months * Participants must have histologically confirmed and documented diagnosis of locally advanced unresectable and/or metastatic sarcoma or a selected solid tumor * Participants must be willing to undergo a tumor biopsy prior to start of treatment or provide archived tumor tissue sample * Participants with sarcoma should have received no more than 2 lines of previous systemic therapies in the metastatic setting * Participants with selected epithelial solid tumors should have received no more than 3 lines of previous systemic therapy in the metastatic/relapsed refractory setting * Participants must have at least one measurable target lesion as defined by RECIST v1.1 * Adequate organ and marrow function as listed per protocol * Must be negative for HIV, HBV, and HCV
Exclusion criteria
* Participants with another known malignancy that has required treatment within the last 2 years * Symptomatic central nervous system (CNS) metastasis, and/or those requiring therapy with corticosteroids or anticonvulsants to control associated symptoms * Participants with leptomeningeal metastasis * Most recent systemic anti-cancer treatment or investigational products/devices less than 3 weeks * Prior treatment with a topoisomerase-1 inhibitor antibody drug conjugate * Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment * Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions * Pregnant or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose Limiting Toxicities | 1 cycle of study treatment (each cycle is 21 days) | Number of subjects with dose limiting toxicities (DLTs) through dose escalation only. |
| Incidence of Treatment Emergent Adverse Events | 36 months | Number of subjects with treatment-emergent adverse effects through dose escalation and expansion. |
| Incidence of Serious adverse events | 36 months | Number of subjects with Serious Adverse Events through dose escalation and expansion. |
| Number of participants with clinical laboratory abnormalities | 36 months | — |
| Number of participants with vital sign abnormalities | 36 months | Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute |
| Number of participants with electrocardiogram (ECG) abnormalities | 36 months | ECG will be measured in ECG intervals (QT and QTc with Fridericia correction, and PR), QRS duration, and heart rate will be tested and analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR per RECIST 1.1 | 36 months | Objective Response Rate (ORR) is defined as the proportion of participants who have a best response of confirmed partial response (PR) or confirmed complete response (CR) to study treatment per RECIST v1.1 by investigator assessment through dose escalation and expansion. |
| Duration of Response per RECIST 1.1 | 36 months | Duration of Response is defined as the time from the first assessment of CR or PR to the first assessment of progression disease (PD) by investigator per RECIST 1.1 or death due to any cause (whichever occurs first) through dose escalation and expansion. |
| PFS per RECIST 1.1 | 36 months | Progression-Free Survival (PFS) is defined as the time from first dosing date to the first documented PD by investigator per RECIST 1.1 or death for any reasons (whichever occurs first) through dose escalation and expansion. |
| DCR per RECIST 1.1 | 36 months | Disease Control Rate (DCR) is defined as the proportion of participants who have a best response of confirmed CR, confirmed PR, or SD per RECIST 1.1 by investigator assessment through dose escalation and expansion. |
| PK characteristics of ZL-6201 (ADC conjugate), total antibody | 36 months | Pharmacokinetics: Total Antibody of ZL-6201 |
| PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads | 36 month | Pharmacokinetics: Unconjugated payloads of ZL-6201 |
Countries
China, United States
Contacts
CONTACTZL-6201-001 Study Team
Outcome results
None listed