Health TrialsbyHealthPanel

GenSci139 in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

This is a phase I, two-part, multicenter, first-in-human study. The Part 1 study will assess the safety, tolerability, preliminary anti-tumor activities, PK profile, immunogenicity and biomarker of GenSci139 in participants with locally advanced or metastatic solid tumors, as well as identity MTD (if any) and RDE. The Part 2 study is to further evaluate the preliminary anti-tumor activities, safety, PK profile, immunogenicity and biomarker of GenSci139 at RDE dose levels with selected advanced cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci139 and any study procedures).

Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.

Adult participants (≥18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent.

Is able to provide tumor tissues. Fresh biopsy specimens or archival tumor tissue samples obtained after last treatment are strongly preferred, and if not available, providing other archival tumor tissue specimens or not may be enrolled after discussion with sponsor.

Disqualifiers

Any active malignancy within 3 years before initiation dose of GenSci139 except for the cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), carcinoma in situ of the cervix or breast).

Has diagnosed as primary central nervous system (CNS) tumor.

Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 4 weeks prior to initiation dose of GenSci139.

Has a history of leptomeningeal disease or spinal cord compression.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GenSci139

    Drug

    GenSci139 is a bispecific antibody drug conjugate targeting EGFR and HER2.

Treatment groups

280 Participants
are divided into 3 treatment groups
Group A: Part1 dose escalationExperimental treatment 1 intervention
Group B: Part 1 backfillExperimental treatment 1 intervention
Group C: Part 2 dose expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 and Part2: Incidence of adverse events

Percentage of patients with adverse events by system organ class and preferred term

Time frame
From time of informed consent to 30 days post last dose of GenSci139
2

Dose limiting toxicities (DLTs)

DLTs are assessed during the DLT observation period and defined as any toxicity in DLT definition in the Clinical Study Protocol

Time frame
from time of first dose of GenSci139 to end of DLT observation period(approximately 21 days)
3

Part1: Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)

To determine the maximum tolerated dose (MTD), if any, and recommend dose of expansion (RDE) for GenSci139

Time frame
from time of first dose of GenSci139 up to 18 months
4

Part2: Objective response rate(ORR)

To evaluate the preliminary anti-tumor activities of GenSci139 as measured by ORR using RECIST criteria v1.1.

Time frame
approximately 12 months

Secondary outcomes

1

Cmax of GenSci139

Calculate maximum observed concentration of GenSci139

Time frame
approximately 24 months
2

Part1: Cmax of total antibody

Calculate maximum observed concentration of total antibody

Time frame
approximately 24 months
3

Part1: Cmax of free payload

Calculate maximum observed concentration of free payload

Time frame
approximately 24 months
4

Part1: Tmax of GenSci139

Calculate time of maximum observed concentration of GenSci139

Time frame
approximately 24 months

Other outcomes

Sponsors and contacts

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

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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