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Advanced Solid TumorsPhase 1NCT05768321

Study of GEC255 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

A Phase 1 study testing GEC255 tablets in people with Advanced Solid Tumors, run by GenEros Biopharma Hangzhou Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
GEC255 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
4 Nov 2021to 30 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • 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)
  • 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.
  • 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.
  • Has estimated survival period ≥ 3 months.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

Who cannot join

  • Has received KRAS inhibitor treatment (for second part only).
  • 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) .
  • Has had any anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy within 4 weeks prior to the first dose of GEC255.
  • Has gastrointestinal disorder affecting absorption (eg, gastrectomy).
  • Has significant cardiovascular disease. Male subjects with corrected QT interval (QTc) ≥ 450ms, female subject with QTc ≥ 470ms
  • Has primary central nervous system (CNS) tumor;
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  • Has unstable brain metastases with meningeal metastasis, spinal cord compression, symptomatic or requiring steroid/anti-epileptic medication 4 weeks before enrollment
  • HIV positive or active infection of hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, tuberculosis
  • Allergic to ingredients of GEC255; or is currently taking medicines which strongly inhibit CYP3A4.

Trial locations and contacts

1 site in 1 country.

XinYu Liu, PhD contact

+8619941365716

xyliu@generosbiopharma.com

China1 site, 1 recruiting

  • China West Hospital

    Chengdu, Sichuan, 610000

    You Lu, MD, 00862885423571, radyoulu@hotmail.com

    Yongmei Liu, 008615308237886, lymi75@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 Open-Label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of GEC255 Oral Tablets in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

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.

Read the 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.

Being tested
GEC255 tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEC255 tabletsDrug

    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

Study groups in NCT05768321
Study groupRoleWhat they receive
GEC255 treatmentExperimentalOral tablet(s), once daily in 28-day cycles
Receives: Drug: GEC255 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients experiencing Dose limiting toxicities (DLTs) during the Maximum tolerated dose (MTD) evaluation period for study drug in monotherapy

    characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug(Part 1)

    Measured: 28 days

  2. Determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen

    Measured by the number of subjects with dose limiting toxicities

    Measured: 24 months

  3. Incidence of Treatment-Emergent Adverse Events

    Characterized by type, frequency, severity (as graded by NCI-CTCAE version 5.0), timing, seriousness

    Measured: 24 months

  4. Incidence of vital signs abnormalities

    Characterized by type, frequency, severity (as graded by NCI CTCAE version5.0), and timing,seriousness

    Measured: 24 months

  5. Incidence of ECG (PR interval, QRS complex, QT corrected interval prolonged, and QT interval corrected using Fridericia's formula) abnormalities

    Characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

    Measured: 24 months

  6. Incidence of laboratory abnormalities

    Characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

    Measured: 24 months

Secondary outcomes (14)

  1. All study parts, Area under the plasma concentration-time curve from time zero to time t(AUC0-t) of GEC255

    All study parts, Area under the plasma concentration-time curve from time zero to time t(AUC0-t) of GEC255

    Measured: Up to 24 months

  2. All study parts,Area under the plasma concentration-time curve from time zero to time infinity(AUC0-∞) of GEC255

    All study parts,Area under the plasma concentration-time curve from time zero to time infinity(AUC0-∞) of GEC255

    Measured: Up to 24 months

  3. All study parts,Area under the plasma concentration-time curve over dosing interval (AUCtau) of GEC255

    All study parts,Area under the plasma concentration-time curve over dosing interval (AUCtau) of GEC255

    Measured: Up to 24 months

  4. All study parts,Apparent plasma clearance of drug after extravascular administration(CL/F) of GEC255

    All study parts,Apparent plasma clearance of drug after extravascular

    Measured: Up to 24 months

  5. All study parts,Terminal half-life(t½) of GEC255

    All study parts,Terminal half-life(t½) of GEC255

    Measured: Up to 24 months

  6. All study parts,Apparent Volume of Distribution(VZ/F) of GEC255

    All study parts,Apparent Volume of Distribution(VZ/F) of GEC255

    Measured: Up to 24 months

  7. All study parts,Maximum concentration (Cmax) of GEC255

    All study parts,Maximum concentration (Cmax) of GEC255

    Measured: Up to 24 months

  8. All study parts,Time to maximum plasma concentration (Tmax) of GEC255

    All study parts,Time to maximum plasma concentration (Tmax) of GEC255

    Measured: Up to 24 months

  9. Overall response rate (ORR) per RECIST v1.1, by treatment

    Overall response rate is defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1, and will be summarized along with the corresponding 95% exact binomial confidence interval (CI)

    Measured: 24 months

  10. Disease Control Rate (DCR) per RECIST v1.1

    The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease. It will be summarized along with the corresponding 95% exact CI

    Measured: 24 months

  11. Duration of Response (DOR) per RECIST v1.1

    Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due any cause. Estimates will use Kaplan-Meier method, and median DOR and corresponding 95% CI will be presented

    Measured: 24 months

  12. Progression-free survival (PFS) per RECIST v1.1

    Per RECIST 1.1, PFS is defined as the time from the date of start of treatment to the date of the first documented progression. If patient has not had an event, PFS will be censored at the date of last adequate tumor assessment

    Measured: 24 months

  13. To evaluate Overall Survival (OS) following initiation of GEC255

    OS is defined as the time from the date of start of treatment to the date of the death

    Measured: 24 months

  14. Evaluation of gene mutations profiles

    Evaluation of gene mutations profiles including KRAS, STK11, KEAP1 etc in cell-free DNA (cfDNA) samples by Next-generation sequencing (NGS) method at various time points during treatment until disease progression

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start4 Nov 2021
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion30 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05768321
Sponsor's protocol ID
GEC255-P1-01
Status last verified
Mar 2023
First submitted
15 Feb 2023
Last updated
16 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEC255 tablets in people with Advanced Solid Tumors, run by GenEros Biopharma Hangzhou Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact XinYu Liu, PhD (+8619941365716, xyliu@generosbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients experiencing Dose limiting toxicities (DLTs) during the Maximum tolerated dose (MTD) evaluation period for study drug in monotherapy (time frame: 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05768321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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