Clinical trial
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
Name
GFH925X1101
Description
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).
Trial arms
Trial start
2021-09-10
Estimated PCD
2024-01-10
Trial end
2024-04-10
Status
Recruiting
Phase
Early phase I
Treatment
GFH925
Administered as an oral tablet formulation
Arms:
GFH925
Size
264
Primary endpoint
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); changes in laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs)
Baseline to 24 Months
Phase Ia: Incidence of dose-limiting toxicity (DLT) events
At the end of Cycle 1（each cycle is 21 days）
Phase Ib: ORR per RECIST 1.1
Continuous evaluation during treatment
Phase II: ORR assessed by Independent Radiographic Review Committee (IRRC) according to RECIST 1.1
Continuous evaluation during treatment
Eligibility criteria
Inclusion Criteria:
1. Volunteer to participate in the study and sign the informed consent form.
2. Aged 18 years or older at the time of signing the informed consent form.
3. Subjects must have one measurable lesion (per RECIST 1.1).
4. 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).
5. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0 \~ 1.
6. Expected survival ≥ 12 weeks.
7. 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.
8. The investigators deem the subject able to communicate well, attend regular follow-up visits, and complete the study according to the protocol.
Exclusion Criteria:
1. Significant cardiovascular system disease.
2. Subjects with unstable brain metastases diagnosed by investigators.
3. 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.
4. Presence of serious acute or chronic infections.
5. Pregnant or lactating women.
6. Known allergy to the study drug or any component of its formulation.
7. Other conditions that the investigators consider inappropriate for participation in this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 264, 'type': 'ESTIMATED'}}
Updated at
2023-08-16
1 organization
1 product
1 abstract
1 indication
Organization
Innovent Biologics (Suzhou)Product
GFH925Indication
KRASG12CAbstract
Efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: Preliminary results from a pooled analysis of two phase I studies.Org: Department of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, The Sixth Affiliated Hospital, SYSU, Guangzhou, China, The Sixth Affiliated hospital, Sun Yat-sen University, Guangzhou, China, Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, Third Affiliated Hospital of Kunming Medical University, Kunming, China, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, Department of Medical Oncology, Sichuan Cancer Hospital, Chengdu, China, Department of Tumor Chemotherapy, Anhui Provincial Hospital, Hefei, China, Department of Oncology, The First Affiliated Hospital of Hunan Traditional Chinese Medical College, Zhuzhou, China,