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KRAS G12CPhase 1/2NCT05005234

A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

A Phase 1/2 study testing GFH925 in people with KRAS G12C, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase Ia: To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
KRAS G12C
What is being tested?
GFH925
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
1 siteChina
Study dates
13 Sep 2021to 20 Dec 2024
Phase
Phase 1/2
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

  • Volunteer to participate in the study and sign the informed consent form.
  • Aged 18 years or older at the time of signing the informed consent form.
  • Subjects must have one measurable lesion (per RECIST 1.1).
  • Subjects with toxic reaction caused by prior anticancer therapy need to have recovered to baseline level (except residual alopecia) or ≤ Grade 1 (neurotoxicity ≤ Grade 2 acceptable).
  • Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0 ~ 1.
  • Expected survival ≥ 12 weeks.
  • Female subjects or male subjects of childbearing potential must take effective contraceptive measures from the time of signing the informed consent form to 30 days after the last dose of GFH925, or to 60 days after the last dose of cetuximab. Female subjects of childbearing potential should have a negative blood pregnancy test within 7 days (inclusive) prior to initiation of study treatment.
  • The investigators deem the subject able to communicate well, attend regular follow-up visits, and complete the study according to the protocol.

Who cannot join

  • Significant cardiovascular system disease.
  • Subjects with unstable brain metastases diagnosed by investigators.
  • Significant gastrointestinal diseases, such as intractable hiccup, nausea, vomiting, severe gastrointestinal ulcers, cirrhosis, active gastrointestinal bleeding, or other diseases that affect swallowing tablets or significantly affect oral drug absorption; subjects with severe portal hypertension caused by the presence of Budd-Chiari syndrome or portal emboli in subjects with liver cancer also need to be excluded.
  • Presence of serious acute or chronic infections.
  • Pregnant or lactating women.
  • Known allergy to the study drug or any component of its formulation.
  • Other conditions that the investigators consider inappropriate for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: An Open-label, Multi-center Phase I/II Clinical Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Effectiveness of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

Phase Ia:

To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925.

Phase Ib:

To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced colorectal cancer or other tumors.

Phase II:

To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).

Conditions
KRAS G12C
Being tested
GFH925

What participants receive

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

  • GFH925Drug

    Administered as an oral tablet formulation

Study groups in NCT05005234
Study groupRoleWhat they receive
GFH925ExperimentalPhase Ia Dose Escalation Subjects with advanced NSCLC and gastrointestinal tumors will be enrolled in dose escalation cohorts based on Bayesian optimal interval (BOIN) design. Phase Ia Dose Expansion Upon completing the dose exploration part of the study and depending on data obtained, dose expansion may proceed with responsive groups consisting of subjects with KRAS G12C mutant advanced NSCLC. Dose expansion may be done concurrently. Phase Ib Subjects with KRAS G12C mutant advanced colorectal cancer or other tumors will be enrolled and treated at the monotherapy RP2D to evaluate the efficacy. Phase 2 Subjects with KRAS G12C mutant advanced NSCLC will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy.
Receives: Drug: GFH925

What is being measured

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

  1. Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); changes in laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs)

    Safety measures

    Measured: Baseline to 24 Months

  2. Phase Ia: Incidence of dose-limiting toxicity (DLT) events

    Safety measures

    Measured: At the end of Cycle 1（each cycle is 21 days）

  3. Phase Ib: ORR per RECIST 1.1

    Efficacy measures

    Measured: Continuous evaluation during treatment

  4. Phase II: ORR assessed by Independent Radiographic Review Committee (IRRC) according to RECIST 1.1

    Efficacy measures

    Measured: Continuous evaluation during treatment

Secondary outcomes (5)

  1. Phase Ia: PK parameters of GFH925 include but are not limited to: Cmax, Tmax, AUC, t1/2, CL/F and Vd/F

    Efficacy measures and safety measures

    Measured: To complete 3 treatments cycles（each cycle is 21 days）

  2. Phase Ia: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS),Overall survival (OS)

    Efficacy measures

    Measured: Continuous evaluation during treatment

  3. Phase Ib and Phase II: DCR, DoR, TTR, PFS per RECIST 1.1, progression-free survival rate at 6 and 12 months, overall survival rate at 12 months

    Efficacy measures

    Measured: Continuous evaluation during treatment

  4. Phase Ib and Phase II: Incidence and severity of AEs, SAEs, AEs leading to treatment interruption, and AEs leading to treatment discontinuation of GFH925 monotherapy

    Safety measures

    Measured: Baseline to 24 Months

  5. Phase Ib and Phase II: Plasma concentration (including Ctrough) after multiple dose administration in subjects

    Efficacy measures and safety measures

    Measured: To complete 3 treatments cycles（each cycle is 21 days）

Timeline

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

  1. First posted13 Aug 2021
  2. Study start13 Sep 2021
  3. Primary completion20 Feb 2023
  4. Study completion20 Dec 2024

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05005234
Sponsor's protocol ID
GFH925X1101
Status last verified
Nov 2025
First submitted
8 Aug 2021
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yuan Y, Deng Y, Jin Y, Guo Z, Pan Y, Wang C, Wang Z, Hu Y, Hua D, Meng X, Zhang Z, Zhao M, Dong X, Huang D, Li X, Liu L, Sun M, Wang H, Wang X, Yang N, Zhang M, Hu S, Wu D, Huang J, Zhang S, Huang M, Ding K. Efficacy and safety of IBI351 (fulzerasib) monotherapy in KRASG12C inhibitor-naive Chinese patients with KRASG12C-mutated metastatic colorectal cancer: a pooled analysis from phase I part of two studies. Signal Transduct Target Ther. 2025 Jul 25;10(1):241. doi: 10.1038/s41392-025-02315-7.

    PubMed 40715048

  • Zhou Q, Meng X, Sun L, Huang D, Yang N, Yu Y, Zhao M, Zhuang W, Guo R, Hu Y, Pan Y, Shan J, Sun M, Yuan Y, Fan Y, Huang J, Liu L, Chu Q, Wang X, Xu C, Lin J, Huang J, Huang M, Sun J, Zhang S, Zhou H, Wu YL. Efficacy and Safety of KRASG12C Inhibitor IBI351 Monotherapy in Patients With Advanced NSCLC: Results From a Phase 2 Pivotal Study. J Thorac Oncol. 2024 Dec;19(12):1630-1639. doi: 10.1016/j.jtho.2024.08.005. Epub 2024 Aug 9.

    PubMed 39127176

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GFH925 in people with KRAS G12C, run by Innovent Biologics (Suzhou) Co. 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 17 Nov 2025. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); changes in laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs) (time frame: Baseline to 24 Months). The study lists 4 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 NCT05005234, which also lists 2 linked publications.

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 17 Nov 2025.

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