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Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors

ConditionsSolid TumorsSarcomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZai Lab (Shanghai) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • ZL-6201

    Drug

    ZL-6201 as a single-agent

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: ZL-6201Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose Limiting Toxicities

Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.

Time frame
1 cycle of study treatment (each cycle is 21 days)
2

Incidence of Treatment Emergent Adverse Events

Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.

Time frame
36 months
3

Incidence of Serious adverse events

Number of subjects with Serious Adverse Events through dose escalation and expansion.

Time frame
36 months
4

Number of participants with clinical laboratory abnormalities

Time frame
36 months

Secondary outcomes

1

ORR per RECIST 1.1

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.

Time frame
36 months
2

Duration of Response per RECIST 1.1

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.

Time frame
36 months
3

PFS per RECIST 1.1

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.

Time frame
36 months
4

DCR per RECIST 1.1

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.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zai Lab (Shanghai) Co., Ltd.

Lead sponsor

Zai Lab (US) LLC

Collaborator

Source ClinicalTrials.gov
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