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Trial Title:
Study of GEC255 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation
NCT ID:
NCT05768321
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GEC255 tablets
Description:
Part 1: Dose escalation After initial starting dose cohort, daily dosages in subsequent
cohorts are determined by cohort review committee.
Part 2: Dose expansion Daily oral dosage RP2D based on data from Part 1
Arm group label:
GEC255 treatment
Summary:
The overall objective of this Phase 1 study is to evaluate the safety, Pharmacokinetics
(PK), and anti-tumor activity of daily oral dosing with GEC255 tablets in subjects with
advanced solid tumor with Kirsten Rat Sarcoma (KRAS) p.G12C mutation. To determine the
recommended Phase 2 dose (RP2D) based on assessments of multiple dose escalation and
expansion in target cohorts.
Detailed description:
This First-in-human dose escalation and expansion study of GEC255 tablets in patients
with advanced solid tumors with KRAS p.G12C mutation aims to evaluate the safety,
tolerability, PK and preliminary efficacy of orally administered GEC255, to determine the
MTD, DLT (if exists) and RP2D, and explore the potential biomarker associated with
efficacy or drug resistance.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Has histologically or cytologically confirmed advance tumors with KRAS p.G12C
mutation and has poor response to standard of care therapy or intolerant to standard
of care therapies (chemotherapy, targeting therapy or immunotherapy).
2. As assessed by the investigator, the subject must have at least one measurable
lesion that meets the definition of Response Evaluation Criteria in Solid Tumours
(RECIST) 1.1 (subjects with only non-target lesions are allowed to be included in
the dose escalation phase)
3. For the second part, subjects with non-small cell lung cancer must have received at
least first-line platinum-based chemotherapy and/or immunotherapy /or anti-vascular
therapy; subjects with colorectal cancer must have previously received second-line
or above therapies and have tumor progression or recurrence. Except for KRAS
mutations and other driver gene-positive subjects, they must have received at least
first-line approved targeted therapy(if any) and are assessed by researchers that
they hardly benefit from existing targeted therapies.
4. Has adequate organ functions, and had no blood transfusion, Erythropoietin (EPO),
colony stimulating factor (CSF) or other supportive medical treatment within 14 days
prior to the first dosing of GEC255.
5. Has estimated survival period ≥ 3 months.
6. Fertile female subjects must have negative serological test for pregnancy. All
subjects must agree to take contraceptive measures from Informed Consent Form (ICF)
signing till 3 months after last treatment.
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Exclusion Criteria:
1. Has received KRAS inhibitor treatment (for second part only).
2. Participated in other interventional clinical trials 4 weeks before enrollment or
within 5 half-lives of the trial drug used last time (whichever is longer) .
3. Has had any anticancer treatments, including immunotherapy, chemotherapy, or
radiotherapy within 4 weeks prior to the first dose of GEC255.
4. Has gastrointestinal disorder affecting absorption (eg, gastrectomy).
5. Has significant cardiovascular disease. Male subjects with corrected QT interval
(QTc) ≥ 450ms, female subject with QTc ≥ 470ms
6. Has primary central nervous system (CNS) tumor;
7. Has unstable brain metastases with meningeal metastasis, spinal cord compression,
symptomatic or requiring steroid/anti-epileptic medication 4 weeks before enrollment
8. HIV positive or active infection of hepatitis B virus (HBV), hepatitis C virus
(HCV), syphilis, tuberculosis
9. Allergic to ingredients of GEC255; or is currently taking medicines which strongly
inhibit CYP3A4.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
China West Hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
You Lu, MD
Phone:
00862885423571
Email:
radyoulu@hotmail.com
Contact backup:
Last name:
Yongmei Liu
Phone:
008615308237886
Email:
lymi75@163.com
Start date:
November 4, 2021
Completion date:
May 30, 2024
Lead sponsor:
Agency:
GenEros Biopharma Hangzhou Ltd
Agency class:
Industry
Source:
GenEros Biopharma Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05768321
